Trial Outcomes & Findings for COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders (NCT NCT05000216)
NCT ID: NCT05000216
Last Updated: 2025-08-22
Results Overview
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
258 participants
Primary outcome timeframe
Week 4 Status Post Receipt of COVID-19 Vaccination
Results posted on
2025-08-22
Participant Flow
19 adult sites and 12 pediatric sites were activated in the United States. 374 adult participants and 9 pediatric participants were screened from August 2021 until April 2023 in Stage 1 and 2 of the trial. Adult arms A3, B3, B6, D1, D3, E1, and E3; Pediatric Stage 1; Pediatric Stage 2 arms D1P, E1P, F1P, and F2P did not randomized/allocate or vaccinate participants. One participant was allocated to Adult arm F1 but was not vaccinated.
In Stage 2, participants could be newly recruited, consent to rollover from Stage 1 of the trial (43 participants), or could consent to receive a second vaccine (Sanofi-GSK) after receipt of a mRNA vaccine in Stage 2 (19 participants).
Participant milestones
| Measure |
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA)
Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA)
Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX)
Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX)
Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT)
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT)
Stage 2 adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna mRNA-1273 vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT)
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F1: Janssen + Withhold IS (BCDT)
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Ad26.COV2.S (Janssen) vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA)
Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Moderna mRNA-1273 Bivalent COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Moderna mRNA-1273 Bivalent vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
2
|
2
|
9
|
10
|
2
|
3
|
3
|
11
|
11
|
41
|
45
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
1
|
1
|
5
|
6
|
1
|
2
|
2
|
5
|
9
|
22
|
13
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
1
|
1
|
4
|
4
|
1
|
1
|
1
|
6
|
2
|
19
|
32
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
0
|
8
|
0
|
57
|
2
|
0
|
1
|
1
|
1
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
5
|
0
|
33
|
2
|
0
|
0
|
1
|
1
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
0
|
24
|
0
|
0
|
1
|
0
|
0
|
|
Stage 2 Sanofi
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
6
|
0
|
0
|
20
|
0
|
0
|
0
|
|
Stage 2 Sanofi
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
3
|
0
|
0
|
17
|
0
|
0
|
0
|
|
Stage 2 Sanofi
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
0
|
0
|
3
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA)
Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA)
Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX)
Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX)
Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT)
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT)
Stage 2 adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna mRNA-1273 vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT)
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F1: Janssen + Withhold IS (BCDT)
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Ad26.COV2.S (Janssen) vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA)
Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Moderna mRNA-1273 Bivalent COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Moderna mRNA-1273 Bivalent vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Did not receive vaccine at Week 0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Received a SARS-CoV-2 vaccine off study
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Rolled over to Stage 2 of the study
|
1
|
0
|
3
|
3
|
0
|
1
|
0
|
2
|
0
|
13
|
18
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
9
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Did not receive vaccine at Week 0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
1
|
0
|
0
|
|
Stage 2
Received a SARS-CoV-2 vaccine off study
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Other reason
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2 Sanofi
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 2 Sanofi
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2 Sanofi
Received a SARS-CoV-2 vaccine off study
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
Baseline characteristics by cohort
| Measure |
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=10 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=11 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=11 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=41 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=9 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA)
n=9 Participants
Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA)
n=5 Participants
Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose
|
Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX)
n=8 Participants
Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX)
n=6 Participants
Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT)
n=57 Participants
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total
|
Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT)
n=2 Participants
Stage 2 adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna mRNA-1273 vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT)
n=20 Participants
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F1: Janssen + Withhold IS (BCDT)
n=1 Participants
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Ad26.COV2.S (Janssen) vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA)
n=1 Participants
Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Moderna mRNA-1273 Bivalent COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX)
n=1 Participants
Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Moderna mRNA-1273 Bivalent vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
Stage 1 · <=18 years
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Age, Categorical
Stage 1 · Between 18 and 65 years
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
6 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
9 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
6 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
4 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
33 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
40 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
8 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
113 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Age, Categorical
Stage 1 · >=65 years
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
3 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
3 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
5 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
7 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
8 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
4 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
34 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Age, Categorical
Stage 2 · <=18 years
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
1 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
3 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Age, Categorical
Stage 2 · Between 18 and 65 years
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
6 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
47 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
62 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Age, Categorical
Stage 2 · >=65 years
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
2 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
9 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
14 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Age, Categorical
Stage 2 Sanofi · <=18 years
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
0 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
0 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Age, Categorical
Stage 2 Sanofi · Between 18 and 65 years
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
4 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
16 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
23 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Age, Categorical
Stage 2 Sanofi · >=65 years
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
2 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
4 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
8 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Age, Continuous
Stage 1
|
62.0 years
STANDARD_DEVIATION 2.89 • n=2 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
41.0 years
STANDARD_DEVIATION 9.90 • n=2 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
50.4 years
STANDARD_DEVIATION 16.34 • n=9 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
44.7 years
STANDARD_DEVIATION 13.12 • n=10 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
59.5 years
STANDARD_DEVIATION 0.71 • n=2 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
70.7 years
STANDARD_DEVIATION 5.69 • n=3 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
64.7 years
STANDARD_DEVIATION 17.39 • n=3 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
62.3 years
STANDARD_DEVIATION 7.98 • n=11 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
66.0 years
STANDARD_DEVIATION 9.96 • n=11 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
51.3 years
STANDARD_DEVIATION 14.81 • n=41 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
45.4 years
STANDARD_DEVIATION 13.02 • n=45 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
55.1 years
STANDARD_DEVIATION 7.15 • n=9 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
51.9 years
STANDARD_DEVIATION 14.46 • n=148 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
|
Age, Continuous
Stage 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
51.4 years
STANDARD_DEVIATION 16.46 • n=9 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
—
|
62.4 years
STANDARD_DEVIATION 4.66 • n=8 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
—
|
51.1 years
STANDARD_DEVIATION 13.41 • n=57 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
54.0 years
STANDARD_DEVIATION 5.66 • n=2 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
—
|
54.0 years
STANDARD_DEVIATION NA • n=1 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
17.0 years
STANDARD_DEVIATION NA • n=1 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
12.0 years
STANDARD_DEVIATION NA • n=1 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
51.5 years
STANDARD_DEVIATION 14.39 • n=79 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
|
Age, Continuous
Stage 2 Sanofi
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
51.6 years
STANDARD_DEVIATION 19.86 • n=5 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
—
|
63.0 years
STANDARD_DEVIATION 9.19 • n=6 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
—
|
—
|
52.9 years
STANDARD_DEVIATION 11.09 • n=20 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
—
|
—
|
—
|
54.7 years
STANDARD_DEVIATION 12.73 • n=31 Participants • Data are being reported separately for stage 1, stage 2 and stage 2 Sanofi.
|
|
Sex: Female, Male
Stage 1 · Female
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
8 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
9 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
3 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
11 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
10 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
27 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
35 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
5 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
116 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Sex: Female, Male
Stage 1 · Male
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
14 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
10 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
4 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
32 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Sex: Female, Male
Stage 2 · Female
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
6 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
43 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
62 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Sex: Female, Male
Stage 2 · Male
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
2 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
14 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
17 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Sex: Female, Male
Stage 2 Sanofi · Female
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
4 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
19 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
28 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Sex: Female, Male
Stage 2 Sanofi · Male
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
2 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
1 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
3 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Ethnicity (NIH/OMB)
Stage 1 · Hispanic or Latino
|
1 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
5 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Ethnicity (NIH/OMB)
Stage 1 · Not Hispanic or Latino
|
1 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
7 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
8 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
3 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
11 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
9 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
40 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
40 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
8 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
132 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Ethnicity (NIH/OMB)
Stage 1 · Unknown or Not Reported
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Ethnicity (NIH/OMB)
Stage 2 · Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
4 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
5 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Ethnicity (NIH/OMB)
Stage 2 · Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
8 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
53 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
74 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Ethnicity (NIH/OMB)
Stage 2 · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Ethnicity (NIH/OMB)
Stage 2 Sanofi · Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
0 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
0 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Ethnicity (NIH/OMB)
Stage 2 Sanofi · Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
6 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
20 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
31 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Ethnicity (NIH/OMB)
Stage 2 Sanofi · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
0 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
0 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 1 · American Indian or Alaska Native
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 1 · Asian
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 1 · Black or African American
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
3 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
6 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
3 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
8 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
30 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 1 · White
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
6 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
3 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
3 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
7 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
6 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
38 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
35 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
7 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
109 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 1 · More than one race
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 1 · Unknown or Not Reported
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=10 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=11 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=41 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=45 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=148 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 · American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 · Asian
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
1 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 · Black or African American
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
6 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
9 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 · White
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
8 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
48 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
65 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 · More than one race
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=9 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
2 Participants
n=57 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
3 Participants
n=79 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 Sanofi · American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
0 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
0 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 Sanofi · Asian
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
1 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
2 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 Sanofi · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
0 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
0 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 Sanofi · Black or African American
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
2 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
3 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 Sanofi · White
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
6 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
17 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
26 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 Sanofi · More than one race
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
0 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
0 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Race (NIH/OMB)
Stage 2 Sanofi · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=5 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
0 Participants
n=6 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
0 Participants
n=20 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
—
|
—
|
—
|
0 Participants
n=31 Participants • Data are being reported separately for Stage 1, Stage 2, and Stage 2 Sanofi.
|
|
Region of Enrollment
United States · Stage 1
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
9 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
41 Participants
n=41 Participants
|
45 Participants
n=45 Participants
|
9 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
148 Participants
n=258 Participants
|
|
Region of Enrollment
United States · Stage 2
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
57 Participants
n=57 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
79 Participants
n=258 Participants
|
|
Region of Enrollment
United States · Stage 2 Sanofi
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=2 Participants
|
20 Participants
n=20 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
31 Participants
n=258 Participants
|
PRIMARY outcome
Timeframe: Week 4 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4
Week 4, Wu-1 Full-Length Spike
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
|
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4
Week 4, Receptor Binding Domain (RBD)
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
PRIMARY outcome
Timeframe: Week 4 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4
Week 4, Wu-1 Full-Length Spike
|
—
|
—
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
—
|
—
|
—
|
|
Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4
Week 4, Receptor Binding Domain (RBD)
|
—
|
—
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 4 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4
Week 4, Wu-1 Full-Length Spike
|
—
|
—
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4
Week 4, Receptor Binding Domain (RBD)
|
—
|
—
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
NA Percentage of participants
Threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody negative (by either Wu-1 full-length spike or RBD) at Week 0 were included in the analysis.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or COVID-19 vaccine given off-study were excluded from the analyses. Participants missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody negative at Week 0 is defined separately for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=4 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=38 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=3 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=4 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=1 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=6 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=42 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=7 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Stage 1 Adult Participants Who Seroconverted
Seroconverted, Wu-1 Full-Length Spike
|
3 Participants
|
13 Participants
|
2 Participants
|
—
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
2 Participants
|
|
Percentage of Stage 1 Adult Participants Who Seroconverted
Seroconverted, Receptor Binding Domain (RBD)
|
2 Participants
|
12 Participants
|
2 Participants
|
—
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
12 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 4 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody negative (by Wu-1 full-length spike or RBD) at Week 0 were included in the analysis.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or COVID-19 vaccine given off-study were excluded from the analyses. Participants missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody negative at Week 0 is defined separately for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=41 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=6 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Stage 2 Adult Participants Who Seroconverted
Seroconverted, Wu-1 Full-Length Spike
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
7 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Percentage of Stage 2 Adult Participants Who Seroconverted
Seroconverted, Receptor Binding Domain (RBD)
|
—
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody positive (by Wu-1 full-length spike or RBD) at Week 0 were included in the analysis.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody positive at Week 0 is defined separately for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=7 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=2 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=1 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=5 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=11 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=1 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels
Fold Change, Wu-1 Full-Length Spike
|
95.54 Fold Change
Geometric Coefficient of Variation 75.93
|
2.58 Fold Change
Geometric Coefficient of Variation 257.03
|
—
|
12.31 Fold Change
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
35.78 Fold Change
Geometric Coefficient of Variation 326.98
|
65.38 Fold Change
Geometric Coefficient of Variation 165.08
|
3.97 Fold Change
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
66.34 Fold Change
Geometric Coefficient of Variation 30.51
|
111.83 Fold Change
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
99.52 Fold Change
Geometric Coefficient of Variation 168.72
|
4.09 Fold Change
Geometric Coefficient of Variation 1485.84
|
2.91 Fold Change
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
|
Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels
Fold Change, Receptor Binding Domain (RBD)
|
80.66 Fold Change
Geometric Coefficient of Variation 115.89
|
4.99 Fold Change
Geometric Coefficient of Variation 1175.81
|
—
|
16.7 Fold Change
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
85.53 Fold Change
Geometric Coefficient of Variation 101.49
|
35.32 Fold Change
Geometric Coefficient of Variation 358.06
|
9.3 Fold Change
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
85.18 Fold Change
Geometric Coefficient of Variation 53.39
|
—
|
67.9 Fold Change
Geometric Coefficient of Variation 142.36
|
1.95 Fold Change
Geometric Coefficient of Variation 86.7
|
4.48 Fold Change
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
SECONDARY outcome
Timeframe: Week 4 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody positive (by Wu-1 full-length spike or RBD) at Week 0 were included in the analysis.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody positive at Week 0 is defined separately for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=7 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=4 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=13 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=16 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels
Fold Change, Wu-1 Full-Length Spike
|
—
|
—
|
54.15 Fold Change
Geometric Coefficient of Variation 103.71
|
9.97 Fold Change
Geometric Coefficient of Variation 146.18
|
49.62 Fold Change
Geometric Coefficient of Variation 603.67
|
5.17 Fold Change
Geometric Coefficient of Variation 278.52
|
2.74 Fold Change
Geometric Coefficient of Variation 287.75
|
—
|
0.82 Fold Change
Geometric Coefficient of Variation 12.82
|
—
|
—
|
—
|
|
Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels
Fold Change, Receptor Binding Domain (RBD)
|
—
|
—
|
93.53 Fold Change
Geometric Coefficient of Variation 111.68
|
17.65 Fold Change
Geometric Coefficient of Variation 309.52
|
44.49 Fold Change
Geometric Coefficient of Variation 716.62
|
5.46 Fold Change
Geometric Coefficient of Variation 299.38
|
4.02 Fold Change
Geometric Coefficient of Variation 648.61
|
—
|
0.8 Fold Change
Geometric Coefficient of Variation 10.47
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Stage 1 Adult Anti-COVID-19 Antibody Response
Week 0, Wu-1 Full-Length Spike
|
11.72 IU/mL
Geometric Coefficient of Variation 117.09
|
0.95 IU/mL
Geometric Coefficient of Variation 289.7
|
2.52 IU/mL
Geometric Coefficient of Variation 221.96
|
224.49 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
14.52 IU/mL
Geometric Coefficient of Variation 196.41
|
8.67 IU/mL
Geometric Coefficient of Variation 1803.07
|
16.83 IU/mL
Geometric Coefficient of Variation 279.39
|
18.83 IU/mL
Geometric Coefficient of Variation 87.58
|
5.31 IU/mL
Geometric Coefficient of Variation 107.14
|
7.22 IU/mL
Geometric Coefficient of Variation 121.07
|
1.99 IU/mL
Geometric Coefficient of Variation 1091.74
|
2.25 IU/mL
Geometric Coefficient of Variation 1536.33
|
|
Change in Stage 1 Adult Anti-COVID-19 Antibody Response
Week 4, Wu-1 Full-Length Spike
|
2211.08 IU/mL
Geometric Coefficient of Variation 252.38
|
4.88 IU/mL
Geometric Coefficient of Variation 5181.02
|
321.14 IU/mL
Geometric Coefficient of Variation 10668.22
|
2763.2 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
518.82 IU/mL
Geometric Coefficient of Variation 452.03
|
632.72 IU/mL
Geometric Coefficient of Variation 2925.17
|
296.41 IU/mL
Geometric Coefficient of Variation 70.11
|
1681.23 IU/mL
Geometric Coefficient of Variation 20.2
|
1104.81 IU/mL
Geometric Coefficient of Variation 436.85
|
459.48 IU/mL
Geometric Coefficient of Variation 1333.45
|
8.02 IU/mL
Geometric Coefficient of Variation 8352.66
|
9.03 IU/mL
Geometric Coefficient of Variation 62605.68
|
|
Change in Stage 1 Adult Anti-COVID-19 Antibody Response
Week 12, Wu-1 Full-Length Spike
|
597.3 IU/mL
Geometric Coefficient of Variation 216.04
|
6.88 IU/mL
Geometric Coefficient of Variation 3896.56
|
356.28 IU/mL
Geometric Coefficient of Variation 6108.73
|
3121.73 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
331.49 IU/mL
Geometric Coefficient of Variation 333.85
|
626.32 IU/mL
Geometric Coefficient of Variation 650.04
|
232.72 IU/mL
Geometric Coefficient of Variation 97.53
|
660.98 IU/mL
Geometric Coefficient of Variation 91.92
|
296.69 IU/mL
Geometric Coefficient of Variation 481.82
|
362.53 IU/mL
Geometric Coefficient of Variation 214.09
|
6.28 IU/mL
Geometric Coefficient of Variation 6838.48
|
5.59 IU/mL
Geometric Coefficient of Variation 1429421.94
|
|
Change in Stage 1 Adult Anti-COVID-19 Antibody Response
Week 0, Receptor Binding Domain (RBD)
|
17.42 IU/mL
Geometric Coefficient of Variation 119.26
|
2.45 IU/mL
Geometric Coefficient of Variation 134.77
|
6.45 IU/mL
Geometric Coefficient of Variation 39.72
|
207.45 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
12.34 IU/mL
Geometric Coefficient of Variation 142.28
|
12.36 IU/mL
Geometric Coefficient of Variation 424.64
|
12.27 IU/mL
Geometric Coefficient of Variation 67.11
|
24.54 IU/mL
Geometric Coefficient of Variation 92.01
|
6.65 IU/mL
Geometric Coefficient of Variation 45.13
|
13.88 IU/mL
Geometric Coefficient of Variation 65.76
|
1.74 IU/mL
Geometric Coefficient of Variation 206.49
|
7.53 IU/mL
Geometric Coefficient of Variation 282.2
|
|
Change in Stage 1 Adult Anti-COVID-19 Antibody Response
Week 4, Receptor Binding Domain (RBD)
|
3074.6 IU/mL
Geometric Coefficient of Variation 246.3
|
8.84 IU/mL
Geometric Coefficient of Variation 943.12
|
434.06 IU/mL
Geometric Coefficient of Variation 157747.37
|
3464.82 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
458.18 IU/mL
Geometric Coefficient of Variation 1185.39
|
491.61 IU/mL
Geometric Coefficient of Variation 7488.68
|
355.86 IU/mL
Geometric Coefficient of Variation 131.08
|
2266.65 IU/mL
Geometric Coefficient of Variation 59.16
|
1751.42 IU/mL
Geometric Coefficient of Variation 544.5
|
601.12 IU/mL
Geometric Coefficient of Variation 797.51
|
7.73 IU/mL
Geometric Coefficient of Variation 3104.64
|
16.64 IU/mL
Geometric Coefficient of Variation 4363.12
|
|
Change in Stage 1 Adult Anti-COVID-19 Antibody Response
Week 12, Receptor Binding Domain (RBD)
|
948.78 IU/mL
Geometric Coefficient of Variation 219.75
|
10.36 IU/mL
Geometric Coefficient of Variation 989.47
|
466.11 IU/mL
Geometric Coefficient of Variation 104511.25
|
3734.51 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
272.17 IU/mL
Geometric Coefficient of Variation 920.54
|
617.58 IU/mL
Geometric Coefficient of Variation 630.84
|
276.55 IU/mL
Geometric Coefficient of Variation 225.66
|
926.48 IU/mL
Geometric Coefficient of Variation 162
|
497.09 IU/mL
Geometric Coefficient of Variation 542.78
|
456.9 IU/mL
Geometric Coefficient of Variation 123.89
|
6.61 IU/mL
Geometric Coefficient of Variation 2278.71
|
12.37 IU/mL
Geometric Coefficient of Variation 102810.04
|
SECONDARY outcome
Timeframe: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Stage 2 Adult Anti-COVID-19 Antibody Response
Week 0, Wu-1 Full-Length Spike
|
—
|
—
|
22.14 IU/mL
Geometric Coefficient of Variation 1247.32
|
48.64 IU/mL
Geometric Coefficient of Variation 23319.38
|
127.11 IU/mL
Geometric Coefficient of Variation 3076.50
|
228.43 IU/mL
Geometric Coefficient of Variation 163.73
|
3.83 IU/mL
Geometric Coefficient of Variation 1803.22
|
0.33 IU/mL
Geometric Coefficient of Variation 144.78
|
139.71 IU/mL
Geometric Coefficient of Variation 8202.42
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Anti-COVID-19 Antibody Response
Week 4, Wu-1 Full-Length Spike
|
—
|
—
|
1329.5 IU/mL
Geometric Coefficient of Variation 3501.10
|
306.1 IU/mL
Geometric Coefficient of Variation 1263457.31
|
6307.1 IU/mL
Geometric Coefficient of Variation 166.16
|
1122.85 IU/mL
Geometric Coefficient of Variation 156.9
|
9.67 IU/mL
Geometric Coefficient of Variation 7718.35
|
0.33 IU/mL
Geometric Coefficient of Variation 145.66
|
137.36 IU/mL
Geometric Coefficient of Variation 5885.99
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Anti-COVID-19 Antibody Response
Week 12, Wu-1 Full-Length Spike
|
—
|
—
|
684.1 IU/mL
Geometric Coefficient of Variation 7400.94
|
205.05 IU/mL
Geometric Coefficient of Variation 683623.84
|
1143.73 IU/mL
Geometric Coefficient of Variation 109.59
|
701.21 IU/mL
Geometric Coefficient of Variation 193.34
|
13.88 IU/mL
Geometric Coefficient of Variation 6077.43
|
0.15 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
88.11 IU/mL
Geometric Coefficient of Variation 4049.13
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Anti-COVID-19 Antibody Response
Week 0, Receptor Binding Domain (RBD)
|
—
|
—
|
18.28 IU/mL
Geometric Coefficient of Variation 314.85
|
40.85 IU/mL
Geometric Coefficient of Variation 5113.92
|
136.55 IU/mL
Geometric Coefficient of Variation 5462.96
|
312.05 IU/mL
Geometric Coefficient of Variation 167.64
|
3.87 IU/mL
Geometric Coefficient of Variation 933.74
|
1.17 IU/mL
Geometric Coefficient of Variation 58.88
|
195.64 IU/mL
Geometric Coefficient of Variation 32100.88
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Anti-COVID-19 Antibody Response
Week 4, Receptor Binding Domain (RBD)
|
—
|
—
|
1583.14 IU/mL
Geometric Coefficient of Variation 2496.89
|
593.17 IU/mL
Geometric Coefficient of Variation 173461.30
|
8464.11 IU/mL
Geometric Coefficient of Variation 216.65
|
1668.91 IU/mL
Geometric Coefficient of Variation 162.22
|
7.56 IU/mL
Geometric Coefficient of Variation 4854.01
|
1.24 IU/mL
Geometric Coefficient of Variation 69.04
|
187.34 IU/mL
Geometric Coefficient of Variation 21600.14
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Anti-COVID-19 Antibody Response
Week 12, Receptor Binding Domain (RBD)
|
—
|
—
|
812.4 IU/mL
Geometric Coefficient of Variation 6728.02
|
311.56 IU/mL
Geometric Coefficient of Variation 120989.28
|
1458.9 IU/mL
Geometric Coefficient of Variation 113.83
|
1030.47 IU/mL
Geometric Coefficient of Variation 203.85
|
11.4 IU/mL
Geometric Coefficient of Variation 3794.97
|
0.8 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
123.87 IU/mL
Geometric Coefficient of Variation 9374.45
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples
Week 0
|
1 Fold Inhibition
Geometric Coefficient of Variation 0
|
1 Fold Inhibition
Geometric Coefficient of Variation 0
|
1 Fold Inhibition
Geometric Coefficient of Variation 0
|
2 Fold Inhibition
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
1 Fold Inhibition
Geometric Coefficient of Variation 0
|
1.08 Fold Inhibition
Geometric Coefficient of Variation 23.42
|
1 Fold Inhibition
Geometric Coefficient of Variation 0.00
|
1 Fold Inhibition
Geometric Coefficient of Variation 0
|
1 Fold Inhibition
Geometric Coefficient of Variation 0
|
1 Fold Inhibition
Geometric Coefficient of Variation 0
|
1.02 Fold Inhibition
Geometric Coefficient of Variation 10.36
|
1.09 Fold Inhibition
Geometric Coefficient of Variation 24.88
|
|
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples
Week 4
|
24.88 Fold Inhibition
Geometric Coefficient of Variation 2444.17
|
1.16 Fold Inhibition
Geometric Coefficient of Variation 38.70
|
15.03 Fold Inhibition
Geometric Coefficient of Variation 154928.64
|
18 Fold Inhibition
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
5.96 Fold Inhibition
Geometric Coefficient of Variation 291.28
|
9.49 Fold Inhibition
Geometric Coefficient of Variation 577.34
|
3.46 Fold Inhibition
Geometric Coefficient of Variation 91.02
|
5.52 Fold Inhibition
Geometric Coefficient of Variation 255.65
|
40.15 Fold Inhibition
Geometric Coefficient of Variation 914418.24
|
6.16 Fold Inhibition
Geometric Coefficient of Variation 383.45
|
1.14 Fold Inhibition
Geometric Coefficient of Variation 31.58
|
1.31 Fold Inhibition
Geometric Coefficient of Variation 73.48
|
|
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples
Week 12
|
4.25 Fold Inhibition
Geometric Coefficient of Variation 203.12
|
1.08 Fold Inhibition
Geometric Coefficient of Variation 22.87
|
9.11 Fold Inhibition
Geometric Coefficient of Variation 13182.95
|
30 Fold Inhibition
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
2.99 Fold Inhibition
Geometric Coefficient of Variation 249.41
|
3.56 Fold Inhibition
Geometric Coefficient of Variation 135.35
|
4.47 Fold Inhibition
Geometric Coefficient of Variation 162.84
|
1.59 Fold Inhibition
Geometric Coefficient of Variation 41.68
|
5.67 Fold Inhibition
Geometric Coefficient of Variation 9124.55
|
2.16 Fold Inhibition
Geometric Coefficient of Variation 63.89
|
1.55 Fold Inhibition
Geometric Coefficient of Variation 653.94
|
1.59 Fold Inhibition
Geometric Coefficient of Variation 94.74
|
SECONDARY outcome
Timeframe: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples
Week 0
|
—
|
—
|
1 Fold Inhibition
Geometric Coefficient of Variation 0.00
|
1.64 Fold Inhibition
Geometric Coefficient of Variation 51.25
|
3.2 Fold Inhibition
Geometric Coefficient of Variation 9598.10
|
1.62 Fold Inhibition
Geometric Coefficient of Variation 59.19
|
1.14 Fold Inhibition
Geometric Coefficient of Variation 86.32
|
1 Fold Inhibition
Geometric Coefficient of Variation 0
|
9.42 Fold Inhibition
Geometric Coefficient of Variation 412.99
|
—
|
—
|
—
|
|
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples
Week 4
|
—
|
—
|
23.32 Fold Inhibition
Geometric Coefficient of Variation 651.97
|
15.31 Fold Inhibition
Geometric Coefficient of Variation 6552.75
|
109.39 Fold Inhibition
Geometric Coefficient of Variation 1119.69
|
7.34 Fold Inhibition
Geometric Coefficient of Variation 1124.11
|
1.54 Fold Inhibition
Geometric Coefficient of Variation 195.75
|
1 Fold Inhibition
Geometric Coefficient of Variation 0
|
6.6 Fold Inhibition
Geometric Coefficient of Variation 268.60
|
—
|
—
|
—
|
|
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples
Week 12
|
—
|
—
|
7.61 Fold Inhibition
Geometric Coefficient of Variation 701.06
|
10.34 Fold Inhibition
Geometric Coefficient of Variation 4255.15
|
5.71 Fold Inhibition
Geometric Coefficient of Variation 319.78
|
4.03 Fold Inhibition
Geometric Coefficient of Variation 451.42
|
1.43 Fold Inhibition
Geometric Coefficient of Variation 117.21
|
1 Fold Inhibition
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
2.9 Fold Inhibition
Geometric Coefficient of Variation 100.15
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4 Status Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=38 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=9 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=44 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C)
Minimally worse
|
1 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C)
Much worse
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C)
Very much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C)
Very much improved
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C)
Much improved
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C)
Minimally improved
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C)
No change
|
7 Participants
|
26 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
42 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Weeks 4 Status Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=52 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Very much improved
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Much improved
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Minimally improved
|
—
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
No change
|
—
|
—
|
7 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
44 Participants
|
2 Participants
|
18 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Minimally worse
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Much worse
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Very much worse
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment
Week 4
|
1.3 cm
Standard Deviation 1.6
|
1.3 cm
Standard Deviation 1.7
|
2.8 cm
Standard Deviation 1.6
|
0.4 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
1.6 cm
Standard Deviation 1.2
|
1.7 cm
Standard Deviation 1.9
|
4.5 cm
Standard Deviation 2.8
|
0.7 cm
Standard Deviation 0.8
|
0.5 cm
Standard Deviation 0.8
|
1.2 cm
Standard Deviation 1.2
|
0.5 cm
Standard Deviation 1
|
0.7 cm
Standard Deviation 1.1
|
|
Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment
Week 0
|
1.2 cm
Standard Deviation 1.8
|
1.1 cm
Standard Deviation 1.5
|
1.1 cm
Standard Deviation 1.3
|
0 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
1.2 cm
Standard Deviation 0.9
|
2.5 cm
Standard Deviation 2.6
|
1.9 cm
Standard Deviation 1.5
|
1.2 cm
Standard Deviation 0.6
|
1.2 cm
Standard Deviation 1.6
|
1.5 cm
Standard Deviation 1.2
|
1.6 cm
Standard Deviation 2.6
|
1.3 cm
Standard Deviation 1.8
|
|
Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment
Week 12
|
1.3 cm
Standard Deviation 1.1
|
1.6 cm
Standard Deviation 1.9
|
2.1 cm
Standard Deviation 2.7
|
0.2 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
1.6 cm
Standard Deviation 1.1
|
1.2 cm
Standard Deviation 1.3
|
3.4 cm
Standard Deviation 4.4
|
1 cm
Standard Deviation 0.7
|
1.8 cm
Standard Deviation 0.8
|
0.7 cm
Standard Deviation 0.9
|
0.8 cm
Standard Deviation 1.5
|
1.1 cm
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment
Week 4
|
—
|
—
|
1.7 cm
Standard Deviation 1.7
|
3.4 cm
Standard Deviation 2.4
|
0.6 cm
Standard Deviation 0.5
|
0.9 cm
Standard Deviation 0.6
|
1.54 cm
Standard Deviation 1.8
|
1.1 cm
Standard Deviation 0.9
|
1.3 cm
Standard Deviation 1.6
|
—
|
—
|
—
|
|
Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment
Week 12
|
—
|
—
|
1.3 cm
Standard Deviation 1.2
|
1.8 cm
Standard Deviation 2.1
|
0.5 cm
Standard Deviation 0.4
|
1 cm
Standard Deviation 0.8
|
1.6 cm
Standard Deviation 1.8
|
0.2 cm
Standard Deviation 0.1
|
1 cm
Standard Deviation 1.4
|
—
|
—
|
—
|
|
Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment
Week 0
|
—
|
—
|
1.7 cm
Standard Deviation 1.6
|
2.6 cm
Standard Deviation 3.1
|
0.4 cm
Standard Deviation 0.4
|
1 cm
Standard Deviation 0.8
|
1.4 cm
Standard Deviation 2
|
0.8 cm
Standard Deviation 0.1
|
1.4 cm
Standard Deviation 1.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Lupus Erythematosus (SLE) are included in the analysis.
The Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=1 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=7 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
Week 0
|
4 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
2 hSLEDAI Score
Standard Deviation 2.19
|
7.83 hSLEDAI Score
Standard Deviation 6.21
|
4 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
2 hSLEDAI Score
Standard Deviation 3.46
|
0.67 hSLEDAI Score
Standard Deviation 1.15
|
2 hSLEDAI Score
Standard Deviation 2.83
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
Week 4
|
4 hSLEDAI Score
Standard Deviation 2.83
|
2 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
4 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
2 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
3.4 hSLEDAI Score
Standard Deviation 2.97
|
5.57 hSLEDAI Score
Standard Deviation 4.31
|
6 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
2.67 hSLEDAI Score
Standard Deviation 3.06
|
0.67 hSLEDAI Score
Standard Deviation 1.15
|
3 hSLEDAI Score
Standard Deviation 4.24
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
Week 12
|
4 hSLEDAI Score
Standard Deviation 2.83
|
0 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
2 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
3.33 hSLEDAI Score
Standard Deviation 3.27
|
5.57 hSLEDAI Score
Standard Deviation 6.11
|
0 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0 hSLEDAI Score
Standard Deviation 0
|
1.33 hSLEDAI Score
Standard Deviation 2.31
|
4 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Lupus Erythematosus (SLE) are included in the analysis.
The Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=3 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=3 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
Week 0
|
—
|
—
|
4 hSLEDAI Score
Standard Deviation 4
|
2 hSLEDAI Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
4 hSLEDAI Score
Standard Deviation 4.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
Week 4
|
—
|
—
|
0.7 hSLEDAI Score
Standard Deviation 1.2
|
4 hSLEDAI Score
Standard Deviation 2.8
|
4.3 hSLEDAI Score
Standard Deviation 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
Week 12
|
—
|
—
|
0.7 hSLEDAI Score
Standard Deviation 1.2
|
2 hSLEDAI Score
Standard Deviation 0
|
3 hSLEDAI Score
Standard Deviation 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Lupus Erythematosus (SLE) are included in the analysis.
The Thanou Modified Safety of Estrogens in Lupus Erythematosus: National Assessment- Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), other disease activity criteria, and hospitalization due to SLE. The hSLEDAI is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=1 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=7 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index
Severe SELENA-SLEDAI Flare at Week 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index
Severe SELENA-SLEDAI Flare at Week 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index
Severe SELENA-SLEDAI Flare at Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Lupus Erythematosus (SLE) are included in the analysis.
The Thanou Modified Safety of Estrogens in Lupus Erythematosus: National Assessment- Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), other disease activity criteria, and hospitalization due to SLE. The hSLEDAI is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=3 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=3 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index
Severe SELENA-SLEDAI Flare at Week 0
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index
Severe SELENA-SLEDAI Flare at Week 4
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index
Severe SELENA-SLEDAI Flare at Week 12
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Rheumatoid Arthritis (RA) are included in the analysis.
The Disease Activity Score 28 C-reactive Protein (DAS28-CRP) is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). Reference: van Gestel AM et al. Arthritis Rheum.1998; 41(10): 1845-50.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=3 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=3 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=7 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=7 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=10 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=8 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 0
|
—
|
—
|
2.7 DAS28-CRP Score
Standard Deviation 1.1
|
2.5 DAS28-CRP Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
2.1 DAS28-CRP Score
Standard Deviation 0.8
|
2.7 DAS28-CRP Score
Standard Deviation 1.3
|
3.1 DAS28-CRP Score
Standard Deviation 1.4
|
3.3 DAS28-CRP Score
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 4
|
—
|
—
|
3 DAS28-CRP Score
Standard Deviation 0.7
|
2.6 DAS28-CRP Score
Standard Deviation 0.9
|
1.6 DAS28-CRP Score
Standard Deviation 0.6
|
2.8 DAS28-CRP Score
Standard Deviation 1.1
|
3.3 DAS28-CRP Score
Standard Deviation 1.3
|
3.3 DAS28-CRP Score
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 12
|
—
|
—
|
3.5 DAS28-CRP Score
Standard Deviation 0
|
3.5 DAS28-CRP Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
2.1 DAS28-CRP Score
Standard Deviation 1.1
|
2.8 DAS28-CRP Score
Standard Deviation 1
|
3.4 DAS28-CRP Score
Standard Deviation 2.3
|
3.2 DAS28-CRP Score
Standard Deviation 1.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Rheumatoid Arthritis (RA) are included in the analysis.
The Disease Activity Score 28 C-reactive Protein (DAS28-CRP) is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). Reference: van Gestel AM et al. Arthritis Rheum.1998; 41(10): 1845-50.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 0
|
—
|
—
|
1.9 DAS28-CRP Score
Standard Deviation 0.6
|
1.8 DAS28-CRP Score
Standard Deviation 0.7
|
2.8 DAS28-CRP Score
Standard Deviation 1.2
|
3 DAS28-CRP Score
Standard Deviation 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 4
|
—
|
—
|
2.1 DAS28-CRP Score
Standard Deviation 0.5
|
2 DAS28-CRP Score
Standard Deviation 0.7
|
2.6 DAS28-CRP Score
Standard Deviation 1
|
2.6 DAS28-CRP Score
Standard Deviation 0.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 12
|
—
|
—
|
1.9 DAS28-CRP Score
Standard Deviation 0.4
|
2 DAS28-CRP Score
Standard Deviation 0.8
|
3 DAS28-CRP Score
Standard Deviation 1.2
|
2.3 DAS28-CRP Score
Standard Deviation 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Sclerosis (SSc) are included in the analysis.
Severe disease flare included onset of new or significant worsening of internal organ involvement requiring hospitalization or change in treatment. Internal organ involvement included scleroderma renal crisis, interstitial lung disease, left or right sided heart failure, pulmonary arterial hypertension on right-sided heart catheterization or other worsening of internal organs.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity
Severe Flare at Week 0
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity
Severe Flare at Week 4
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity
Severe Flare at Week 12
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Sclerosis (SSc) are included in the analysis.
Severe disease flare included onset of new or significant worsening of internal organ involvement requiring hospitalization or change in treatment. Internal organ involvement included scleroderma renal crisis, interstitial lung disease, left or right sided heart failure, pulmonary arterial hypertension on right-sided heart catheterization or other worsening of internal organs.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=3 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity
Severe Flare at Week 0
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity
Severe Flare at Week 4
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity
Severe Flare at Week 12
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Pemphigus are included in the analysis.
The Pemphigus Disease Area Index (PDAI) was developed by the International Pemphigus Committee and measures both activity of and damage due to pemphigus on the skin, scalp, and mucous membranes. Total scores can range from 0 to a possible 263 maximum score, with 250 points representing disease activity (120 points for skin activity, 10 points for scalp activity, and 120 points for mucosal activity) and 13 points representing disease damage. Higher scores reflect worse disease.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus
Week 0
|
—
|
—
|
1 PDAI Total Activity Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0 PDAI Total Activity Score
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus
Week 4
|
—
|
—
|
5 PDAI Total Activity Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0 PDAI Total Activity Score
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus
Week 12
|
—
|
—
|
0 PDAI Total Activity Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
1 PDAI Total Activity Score
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Pemphigus are included in the analysis.
The Pemphigus Disease Area Index (PDAI) was developed by the International Pemphigus Committee and measures both activity of and damage due to pemphigus on the skin, scalp, and mucous membranes. Total scores can range from 0 to a possible 263 maximum score, with 250 points representing disease activity (120 points for skin activity, 10 points for scalp activity, and 120 points for mucosal activity) and 13 points representing disease damage. Higher scores reflect worse disease.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=4 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus
Week 0
|
—
|
—
|
0 PDAI Total Activity Score
Standard Deviation 0
|
0 PDAI Total Activity Score
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus
Week 4
|
—
|
—
|
0 PDAI Total Activity Score
Standard Deviation 0
|
0 PDAI Total Activity Score
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus
Week 12
|
—
|
—
|
0 PDAI Total Activity Score
Standard Deviation 0
|
0 PDAI Total Activity Score
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Multiple Sclerosis (MS) are included in the analysis.
Relapse required: either criteria (a) with investigator determination of relapse or criteria (a) and (b): (a) New, recurrent or worsening neurological symptoms attributable to MS, that meet all of the following: i. Appeared or evolved subacutely (over \<3 months). ii. Persisting \>24 hours. iii. Can't be attributed to confounding factors. iv. Occur ≥30 days after onset of a prior confirmed relapse. (b) New, recurrent or worsening neurological symptoms accompanied by corresponding objective worsening on neurologic examination with an increase of any one of the following compared to the immediate prior assessment: i. ≥0.5 step(s) on the Expanded Disability Status Scale (EDSS), ii. ≥2 points on one Functional Systems Score (FSS), iii. ≥1 point on two or more FSS. Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder/bowel urgency or incontinence will not suffice to establish relapse. Sexual dysfunction and fatigue will not contribute to the EDSS/FSS for assessing relapse.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=26 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=34 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=7 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS
MS Relapse at Screening
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS
MS Relapse at Week 4
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS
MS Relapse at Week 12
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study. Only participants with Multiple Sclerosis (MS) are included in the analysis.
Relapse required: either criteria (a) with investigator determination of relapse or criteria (a) and (b): (a) New, recurrent or worsening neurological symptoms attributable to MS, that meet all of the following: i. Appeared or evolved subacutely (over \<3 months). ii. Persisting \>24 hours. iii. Can't be attributed to confounding factors. iv. Occur ≥30 days after onset of a prior confirmed relapse. (b) New, recurrent or worsening neurological symptoms accompanied by corresponding objective worsening on neurologic examination with an increase of any one of the following compared to the immediate prior assessment: i. ≥0.5 step(s) on the Expanded Disability Status Scale (EDSS), ii. ≥2 points on one Functional Systems Score (FSS), iii. ≥1 point on two or more FSS. Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder/bowel urgency or incontinence will not suffice to establish relapse. Sexual dysfunction and fatigue will not contribute to the EDSS/FSS for assessing relapse.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=37 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=12 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS
MS Relapse at Screening
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS
MS Relapse at Week 4
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS
MS Relapse at Week 12
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
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—
|
—
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—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study. Only participants with Juvenile Idiopathic Arthritis (JIA) are included in the analysis.
The Juvenile Arthritis Disease Activity Score 10-C-reactive Protein (JADAS10-CRP) is a score on a scale (0 to 40) indicating activity of juvenile idiopathic arthritis. Total active joints are scored 0 to 10, with an active joint count \>10 scored as 10 points. The Physician's Global Assessment and Patient's Global Assessment are measured on a 0-10 scale (0 cm, no disease activity to 10 cm, worst disease activity). CRP is normalized to a 0 to 10 scale according to the following formula: (CRP (mg/L) - 10)/10. CRP values \<10 mg/L are scored as 0, and CRP \>110 mg/L are scored as 10. The final score is given by the simple sum of its component. Higher scores indicate worse disease activity.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 2 Pediatric Participants With Juvenile Idiopathic Arthritis (JIA) as Measured by the Juvenile Arthritis Disease Activity Score 10 (JADAS10)
Week 0
|
—
|
—
|
0.8 JADAS10 Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Pediatric Participants With Juvenile Idiopathic Arthritis (JIA) as Measured by the Juvenile Arthritis Disease Activity Score 10 (JADAS10)
Week 4
|
—
|
—
|
0.6 JADAS10 Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Pediatric Participants With Juvenile Idiopathic Arthritis (JIA) as Measured by the Juvenile Arthritis Disease Activity Score 10 (JADAS10)
Week 12
|
—
|
—
|
0.4 JADAS10 Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Physical Function domain score is presented. A higher score represents better functioning for the Physical Function domain.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Week 0
|
41.8 T-Score
Standard Deviation 12
|
43.5 T-Score
Standard Deviation 9.5
|
37.9 T-Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
43.4 T-Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
47.6 T-Score
Standard Deviation 10.1
|
40.2 T-Score
Standard Deviation 3.9
|
35.6 T-Score
Standard Deviation 3.3
|
50.1 T-Score
Standard Deviation 6.1
|
39.6 T-Score
Standard Deviation 5
|
48.9 T-Score
Standard Deviation 9
|
44.2 T-Score
Standard Deviation 9.9
|
43.5 T-Score
Standard Deviation 11.8
|
|
Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Week 4
|
41.7 T-Score
Standard Deviation 10.5
|
43.5 T-Score
Standard Deviation 9.1
|
39.8 T-Score
Standard Deviation 0.9
|
41.8 T-Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
48.9 T-Score
Standard Deviation 8.7
|
42.7 T-Score
Standard Deviation 10
|
41.9 T-Score
Standard Deviation 2.1
|
46.5 T-Score
Standard Deviation 2.7
|
42.7 T-Score
Standard Deviation 12.3
|
47.2 T-Score
Standard Deviation 10.5
|
44.7 T-Score
Standard Deviation 10.5
|
43.6 T-Score
Standard Deviation 11.7
|
|
Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Week 12
|
41.1 T-Score
Standard Deviation 11.9
|
43.5 T-Score
Standard Deviation 9.4
|
37.3 T-Score
Standard Deviation 0.8
|
56.9 T-Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
47.6 T-Score
Standard Deviation 10.1
|
42.1 T-Score
Standard Deviation 7.7
|
35 T-Score
Standard Deviation 2.4
|
45.3 T-Score
Standard Deviation 0
|
39.3 T-Score
Standard Deviation 7.5
|
46.1 T-Score
Standard Deviation 11.5
|
44.7 T-Score
Standard Deviation 9.5
|
44.1 T-Score
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Physical Function domain score is presented. A higher score represents better functioning for the Physical Function domain.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Week 0
|
—
|
—
|
44.9 T-Score
Standard Deviation 7.9
|
46.3 T-Score
Standard Deviation 7.6
|
48.3 T-Score
Standard Deviation 10.4
|
48.3 T-Score
Standard Deviation 8.4
|
45.9 T-Score
Standard Deviation 9.9
|
56.9 T-Score
Standard Deviation 0
|
47.1 T-Score
Standard Deviation 9.5
|
—
|
—
|
—
|
|
Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Week 4
|
—
|
—
|
46.4 T-Score
Standard Deviation 8.5
|
42.5 T-Score
Standard Deviation 10.5
|
48.4 T-Score
Standard Deviation 10.4
|
47.2 T-Score
Standard Deviation 9.4
|
44.9 T-Score
Standard Deviation 9.6
|
56.9 T-Score
Standard Deviation 0
|
48.6 T-Score
Standard Deviation 9.6
|
—
|
—
|
—
|
|
Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Week 12
|
—
|
—
|
45.5 T-Score
Standard Deviation 9.3
|
46.8 T-Score
Standard Deviation 9.3
|
47.6 T-Score
Standard Deviation 9
|
44.2 T-Score
Standard Deviation 8.5
|
43.9 T-Score
Standard Deviation 10
|
51.1 T-Score
Standard Deviation 8.2
|
48.3 T-Score
Standard Deviation 9.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment
Week 0
|
5.1 cm
Standard Deviation 3.6
|
3.8 cm
Standard Deviation 2.4
|
7.2 cm
Standard Deviation 2.1
|
3 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
3.1 cm
Standard Deviation 2.9
|
3.8 cm
Standard Deviation 2.9
|
5.8 cm
Standard Deviation 1.8
|
4.8 cm
Standard Deviation 1.9
|
5.4 cm
Standard Deviation 1.6
|
3.7 cm
Standard Deviation 2.4
|
3.2 cm
Standard Deviation 2.9
|
3.9 cm
Standard Deviation 3.2
|
|
Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment
Week 4
|
4.9 cm
Standard Deviation 3.6
|
3.3 cm
Standard Deviation 2.6
|
7.9 cm
Standard Deviation 0.5
|
6.5 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
2.7 cm
Standard Deviation 2.3
|
3.1 cm
Standard Deviation 2.3
|
4.9 cm
Standard Deviation 4.4
|
6.5 cm
Standard Deviation 0.9
|
5.6 cm
Standard Deviation 1.8
|
3.6 cm
Standard Deviation 2.9
|
2.6 cm
Standard Deviation 2.4
|
3 cm
Standard Deviation 2.6
|
|
Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment
Week 12
|
4.9 cm
Standard Deviation 3
|
3.5 cm
Standard Deviation 2.5
|
5.8 cm
Standard Deviation 1.1
|
7.5 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
3.5 cm
Standard Deviation 2.9
|
3.7 cm
Standard Deviation 3.2
|
6.2 cm
Standard Deviation 1.1
|
4.6 cm
Standard Deviation 1.1
|
6.8 cm
Standard Deviation 1.5
|
4.3 cm
Standard Deviation 3.1
|
2.3 cm
Standard Deviation 2.2
|
2.3 cm
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment
Week 0
|
—
|
—
|
3.2 cm
Standard Deviation 2.6
|
2.7 cm
Standard Deviation 3.4
|
3.2 cm
Standard Deviation 2.1
|
2.8 cm
Standard Deviation 2.6
|
2.7 cm
Standard Deviation 2.5
|
2.6 cm
Standard Deviation 3.4
|
2.6 cm
Standard Deviation 2.6
|
—
|
—
|
—
|
|
Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment
Week 4
|
—
|
—
|
3 cm
Standard Deviation 2.1
|
2.9 cm
Standard Deviation 3.1
|
3 cm
Standard Deviation 2.5
|
3 cm
Standard Deviation 2
|
3 cm
Standard Deviation 2.5
|
1 cm
Standard Deviation 1.4
|
2.7 cm
Standard Deviation 2.9
|
—
|
—
|
—
|
|
Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment
Week 12
|
—
|
—
|
2.9 cm
Standard Deviation 2.7
|
1.8 cm
Standard Deviation 2.2
|
3.1 cm
Standard Deviation 2.3
|
3.9 cm
Standard Deviation 2.7
|
3.1 cm
Standard Deviation 2.5
|
2.5 cm
Standard Deviation 3.5
|
1.9 cm
Standard Deviation 2.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4 Status Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=38 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=9 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=44 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Much improved
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Very much improved
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Minimally improved
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
No change
|
6 Participants
|
31 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
41 Participants
|
7 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Minimally worse
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Much worse
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Very much worse
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 4 Status Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=52 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Very much improved
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Much improved
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Minimally improved
|
—
|
—
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
No change
|
—
|
—
|
7 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
46 Participants
|
2 Participants
|
19 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Minimally worse
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Much worse
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Very much worse
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as "possibly related" (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or "related" (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as "possibly related" (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or "related" (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine
|
—
|
—
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
An event is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered "life-threatening" if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs)
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
An event is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered "life-threatening" if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs)
|
—
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs)
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
Efficacy measure.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 Participants
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection
|
6 Participants
|
14 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
COVID-19 infections (all grades) were confirmed by molecular COVID-19 testing. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=9 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=5 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=6 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=53 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=2 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=20 Participants
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection
|
—
|
—
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
20 Participants
|
0 Participants
|
6 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody negative at Week 0 were included in the analysis.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858), defined independently for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Stage 2 Pediatric Participants Who Seroconverted
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody positive at Week 0 were included in the analysis.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858), defined independently for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fold Increase in Stage 2 Pediatric Anti-COVID-19 Antibody Levels
Fold Change, Wu-1 Full-Length Spike
|
—
|
—
|
149.84 Fold Change
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Increase in Stage 2 Pediatric Anti-COVID-19 Antibody Levels
Fold Change, Receptor Binding Domain (RBD)
|
—
|
—
|
112.05 Fold Change
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response
Week 0, Wu-1 Full-Length Spike
|
—
|
—
|
1.27 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
123.28 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response
Week 4, Wu-1 Full-Length Spike
|
—
|
—
|
6.53 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
18473.06 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response
Week 12, Wu-1 Full-Length Spike
|
—
|
—
|
—
|
3583.89 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response
Week 0, Receptor Binding Domain (RBD)
|
—
|
—
|
2.49 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
175.7 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response
Week 4, Receptor Binding Domain (RBD)
|
—
|
—
|
10.65 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
19688.14 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response
Week 12, Receptor Binding Domain (RBD)
|
—
|
—
|
—
|
3664.63 IU/mL
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 VaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples
Week 0
|
—
|
—
|
1 Fold Inhibition
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
1 Fold Inhibition
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples
Week 4
|
—
|
—
|
1 Fold Inhibition
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
722 Fold Inhibition
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
|
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples
Week 12
|
—
|
—
|
—
|
158 Fold Inhibition
Geometric Coefficient of Variation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
SECONDARY outcome
Timeframe: Weeks 4 Status Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Very much improved
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Much improved
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Minimally improved
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
No change
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Minimally worse
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Much worse
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
Very much worse
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment
Week 0
|
—
|
—
|
0 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0.8 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment
Week 4
|
—
|
—
|
0 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0.6 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment
Week 12
|
—
|
—
|
0 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0.4 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study. Only participants with Systemic Lupus Erythematosus (SLE) are included in the analysis.
The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. SLEDAI-2K total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Activity in Stage 2 Pediatric Participants With Systemic Lupus Erythematosus (SLE) as Measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
Week 0
|
—
|
—
|
2 SLEDAI-2K Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Pediatric Participants With Systemic Lupus Erythematosus (SLE) as Measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
Week 4
|
—
|
—
|
2 SLEDAI-2K Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Disease Activity in Stage 2 Pediatric Participants With Systemic Lupus Erythematosus (SLE) as Measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
Week 12
|
—
|
—
|
0 SLEDAI-2K Score
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment
Week 0
|
—
|
—
|
5 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment
Week 4
|
—
|
—
|
5 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment
Week 12
|
—
|
—
|
5 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
0 cm
Standard Deviation NA
Sample size didn't support displaying the descriptive statistic
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4 Status Post Receipt of COVID-19 Vaccine DosePopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Very much improved
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Much improved
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Minimally improved
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
No change
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Minimally worse
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Much worse
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
Very much worse
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as "possibly related" (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or "related" (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Pediatric Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
An event is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered "life-threatening" if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Pediatric Participants Who Experience Any Serious Adverse Events (SAEs)
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Pediatric Participants Who Experience Any Medically Attended Adverse Events (MAAEs)
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Pediatric Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48 post study vaccinationPopulation: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
COVID-19 infections (all grades) were confirmed by molecular COVID-19 testing. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0.
Outcome measures
| Measure |
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 Participants
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Stage 2 Pediatric Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT)
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 participants at risk
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 participants at risk
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 participants at risk
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 participants at risk
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 participants at risk
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 participants at risk
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 participants at risk
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 participants at risk
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 participants at risk
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 participants at risk
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 participants at risk
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 participants at risk
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA)
n=9 participants at risk
Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA)
n=5 participants at risk
Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX)
n=8 participants at risk
Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2), but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX)
n=6 participants at risk
Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT)
n=53 participants at risk
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2), per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT)
n=2 participants at risk
Stage 2 adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna mRNA-1273 vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT)
n=20 participants at risk
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA)
n=1 participants at risk
Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Moderna mRNA-1273 Bivalent COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX)
n=1 participants at risk
Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Moderna mRNA-1273 Bivalent vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.2%
1/45 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
1.9%
1/53 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
20.0%
1/5 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
1.9%
1/53 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
50.0%
1/2 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Cardiac disorders
Cardiomyopathy alcoholic
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.5%
1/40 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.2%
1/45 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Congenital, familial and genetic disorders
Pulmonary malformation
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.5%
1/40 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
10.0%
1/10 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.2%
1/45 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
1.9%
1/53 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
1.9%
1/53 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
5.0%
1/20 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.2%
1/45 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.5%
1/40 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
11.1%
1/9 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
1.9%
1/53 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.2%
1/45 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.2%
1/45 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
1.9%
1/53 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Nervous system disorders
Uhthoff's phenomenon
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.5%
1/40 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.5%
1/40 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Vascular disorders
Haematoma
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
1.9%
1/53 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
Other adverse events
| Measure |
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
n=2 participants at risk
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
n=1 participants at risk
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)
n=8 participants at risk
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)
n=9 participants at risk
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)
n=2 participants at risk
Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
n=3 participants at risk
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
n=3 participants at risk
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)
n=10 participants at risk
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)
n=10 participants at risk
Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)
n=40 participants at risk
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT)
n=45 participants at risk
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort C, Arm C3: Janssen + Continue IS (BCDT)
n=8 participants at risk
Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
|
Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA)
n=9 participants at risk
Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA)
n=5 participants at risk
Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX)
n=8 participants at risk
Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2), but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX)
n=6 participants at risk
Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT)
n=53 participants at risk
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2), per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT)
n=2 participants at risk
Stage 2 adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna mRNA-1273 vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT)
n=20 participants at risk
Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total.
|
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA)
n=1 participants at risk
Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Moderna mRNA-1273 Bivalent COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX)
n=1 participants at risk
Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Moderna mRNA-1273 Bivalent vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
12.5%
1/8 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
11.1%
1/9 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
General disorders
Chest pain
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
11.1%
1/9 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
General disorders
Injection site induration
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
16.7%
1/6 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
General disorders
Injection site pain
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
16.7%
1/6 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
General disorders
Injection site reaction
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
11.1%
1/9 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
1.9%
1/53 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
General disorders
Injection site swelling
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
16.7%
1/6 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
COVID-19
|
50.0%
1/2 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
37.5%
3/8 • Number of events 3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
33.3%
3/9 • Number of events 3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
33.3%
1/3 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
30.0%
3/10 • Number of events 4 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
50.0%
5/10 • Number of events 5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
35.0%
14/40 • Number of events 15 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
24.4%
11/45 • Number of events 12 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
75.0%
6/8 • Number of events 6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
22.2%
2/9 • Number of events 2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
20.0%
1/5 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
12.5%
1/8 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
50.0%
3/6 • Number of events 4 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
37.7%
20/53 • Number of events 22 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
30.0%
6/20 • Number of events 7 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
12.5%
1/8 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
12.5%
1/8 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
12.5%
1/8 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.5%
1/40 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.2%
1/45 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
11.1%
1/9 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
5.0%
1/20 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
20.0%
1/5 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
11.1%
1/9 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
11.1%
1/9 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
11.1%
1/9 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
5.0%
1/20 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
5.0%
1/20 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
10.0%
1/10 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/45 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
33.3%
1/3 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/3 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/10 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/40 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
2.2%
1/45 • Number of events 1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/9 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/5 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/8 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/6 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/53 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/2 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/20 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
0.00%
0/1 • All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).
Adverse events are reported in the vaccinated population, which includes all participants who were randomized or allocated and received study vaccine in the trial. No participants in the "Cohort F, Arm F1: Janssen + Withhold IS (BCDT)" arm were vaccinated.
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place