Trial Outcomes & Findings for COVID Protection After Transplant - Sanofi GSK (CPAT-SG) Study (NCT NCT05518487)
NCT ID: NCT05518487
Last Updated: 2025-06-25
Results Overview
The antibody is measured by using the Roche Elecsys(R) anti-RBD assay
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
At 30 days following a dose of vaccine
Results posted on
2025-06-25
Participant Flow
Participant milestones
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
One participant vaccinated on study was subsequently discovered to have an inaccurate baseline antibody level of ≥ 2500 U/ml (2948.5 U/ml). This participant was excluded from the immunogenicity population for the primary endpoint as well as the corresponding baseline population.
Baseline characteristics by cohort
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Age, Continuous
|
71 years
n=15 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
|
Years Since Transplant
|
5.1 years
n=15 Participants
|
|
Number of Prior COVID-19 Vaccines Received
Four
|
1 Participants
n=15 Participants
|
|
Number of Prior COVID-19 Vaccines Received
Five
|
11 Participants
n=15 Participants
|
|
Number of Prior COVID-19 Vaccines Received
Six
|
3 Participants
n=15 Participants
|
|
Days Between Last Vaccination and Antibody Screening
|
222.5 days
n=15 Participants
|
|
Baseline SARS-CoV-2 Antibody Level
|
223.5 U/mL
n=14 Participants • One participant vaccinated on study was subsequently discovered to have an inaccurate baseline antibody level of ≥ 2500 U/ml (2948.5 U/ml). This participant was excluded from the immunogenicity population for the primary endpoint as well as the corresponding baseline population.
|
PRIMARY outcome
Timeframe: At 30 days following a dose of vaccinePopulation: 1 participant received study vaccine but was excluded from primary immunogenicity population; baseline SARS-CoV-2 was initially misreported as eligible (≤ 2500 U/ml). This patient is included in the demographics/baseline description population and in non-immunogenicity clinical or safety outcomes (e.g. death, graft loss, need for dialysis, acute rejection).
The antibody is measured by using the Roche Elecsys(R) anti-RBD assay
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=14 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
The Proportion of Participants Who Reach a SARS-CoV-2 S Antibody Level >5000 U/mL
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 days following the study dose of vaccinePopulation: Safety Population: Participant receiving study vaccine
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Composite That Includes Death, Graft Loss, Need for Dialysis, and Acute Rejection
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 days or within 60 days of the study dose of vaccinePopulation: Safety population (Participant receiving study vaccine). 1 participant terminated the study after day 30. This patient who terminated prior to evaluation at 60 days had not had the 'event' at the time of termination and was censored.
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Death
Death within 30 days of vaccine
|
0 Participants
|
|
Death
Death within 60 days of vaccine
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 days or within 60 days of the study dose of vaccinePopulation: Safety population (Participant receiving study vaccine). 1 participant terminated the study after day 30. This patient who terminated prior to evaluation at 60 days had not had the 'event' at the time of termination and was censored.
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Graft Loss
Graft loss within 30 days of vaccine
|
0 Participants
|
|
Graft Loss
Graft loss within 60 days of vaccine
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 days or within 60 days of the study dose of vaccinePopulation: Safety population (Participant receiving study vaccine) 1 participant terminated the study after day 30. This patient who terminated prior to evaluation at 60 days had not had the 'event' at the time of termination and was censored.
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Need for Dialysis
Need for dialysis within 30 days of vaccine
|
0 Participants
|
|
Need for Dialysis
Need for dialysis within 60 days of vaccine
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 days or within 60 days of the study dose of vaccinePopulation: Safety population (Participant receiving study vaccine). 1 participant terminated the study after day 30. This patient who terminated prior to evaluation at 60 days had not had the 'event' at the time of termination and was censored.
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Acute Rejection
Within 30 days
|
0 Participants
|
|
Acute Rejection
Within 60 days
|
0 Participants
|
SECONDARY outcome
Timeframe: Collected for 7 days following the study dose of vaccine)Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Local Vaccine Reactogenicity
Injection Site Pain · Grade 0 (None)
|
3 Participants
|
|
Local Vaccine Reactogenicity
Injection Site Pain · Grade 1 (Mild)
|
11 Participants
|
|
Local Vaccine Reactogenicity
Injection Site Pain · Grade 2 (Moderate)
|
1 Participants
|
|
Local Vaccine Reactogenicity
Redness · Grade 0 (None)
|
14 Participants
|
|
Local Vaccine Reactogenicity
Redness · Grade 1 (Mild)
|
0 Participants
|
|
Local Vaccine Reactogenicity
Redness · Grade 2 (Moderate)
|
1 Participants
|
|
Local Vaccine Reactogenicity
Swelling · Grade 0 (None)
|
14 Participants
|
|
Local Vaccine Reactogenicity
Swelling · Grade 1 (Mild)
|
0 Participants
|
|
Local Vaccine Reactogenicity
Swelling · Grade 2 (Moderate)
|
1 Participants
|
SECONDARY outcome
Timeframe: Collected for 7 days following the study dose of vaccine)Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Systemic Vaccine Reactogenicity
Fever · Grade 0 (None)
|
15 Participants
|
|
Systemic Vaccine Reactogenicity
Fever · Grade 1 (Mild)
|
0 Participants
|
|
Systemic Vaccine Reactogenicity
Fever · Grade 2 (Moderate)
|
0 Participants
|
|
Systemic Vaccine Reactogenicity
Headache · Grade 0 (None)
|
14 Participants
|
|
Systemic Vaccine Reactogenicity
Headache · Grade 1 (Mild)
|
0 Participants
|
|
Systemic Vaccine Reactogenicity
Headache · Grade 2 (Moderate)
|
1 Participants
|
|
Systemic Vaccine Reactogenicity
Tired · Grade 0 (None)
|
10 Participants
|
|
Systemic Vaccine Reactogenicity
Tired · Grade 1 (Mild)
|
4 Participants
|
|
Systemic Vaccine Reactogenicity
Tired · Grade 2 (Moderate)
|
1 Participants
|
|
Systemic Vaccine Reactogenicity
Muscle Pain · Grade 0 (None)
|
14 Participants
|
|
Systemic Vaccine Reactogenicity
Muscle Pain · Grade 1 (Mild)
|
0 Participants
|
|
Systemic Vaccine Reactogenicity
Muscle Pain · Grade 2 (Moderate)
|
1 Participants
|
|
Systemic Vaccine Reactogenicity
Joint Pain · Grade 0 (None)
|
13 Participants
|
|
Systemic Vaccine Reactogenicity
Joint Pain · Grade 1 (Mild)
|
1 Participants
|
|
Systemic Vaccine Reactogenicity
Joint Pain · Grade 2 (Moderate)
|
1 Participants
|
|
Systemic Vaccine Reactogenicity
Chills · Grade 0 (None)
|
13 Participants
|
|
Systemic Vaccine Reactogenicity
Chills · Grade 1 (Mild)
|
1 Participants
|
|
Systemic Vaccine Reactogenicity
Chills · Grade 2 (Moderate)
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 year following the study dose of vaccinePopulation: Safety Population (includes all subjects, including all follow-up for the 1 participant who decided to terminate early, and the 1 participant whose baseline antibody titer was misreported, and thus enrolled despite having an ineligible baseline antibody titer \> 2500 U/ml).
The categories of AESI that required special reporting in this protocol were: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; Potential immune-mediated diseases (pIMDs)
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Adverse Events of Special Interest (AESIs), Including Potential Immune Mediated Diseases
Experienced AESI
|
0 Participants
|
|
Adverse Events of Special Interest (AESIs), Including Potential Immune Mediated Diseases
Did not experience AESI
|
15 Participants
|
SECONDARY outcome
Timeframe: Within 60 days following the study dose of vaccinePopulation: Safety Population. 1 participant terminated the study after day 30, prior to 60 day follow-up. One participant decided to terminate the study after day 30, prior to 90 days assessment; this participant had not experienced clinical or biopsy-proven rejection at any time prior to termination.
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=14 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Treated Acute Cell-mediated Allograft Rejection (Clinical or Biopsy-proven)
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 60 days following the study dose of vaccinePopulation: Safety population (Participant receiving study vaccine). 1 participant terminated the study after day 30, prior to 60-day follow-up. One participant decided to terminate the study after day 30, prior to 60 days assessment; this participant had not experienced clinical or biopsy-proven anitbody-mediated rejection at any time prior to termination.
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=14 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Treated Antibody-mediated Allograft Rejection (Clinical or Biopsy-proven)
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 90 days of the vaccine and up to 12-months post vaccinePopulation: Safety population (Participant receiving study vaccine). 3 participants terminated the study prior to 1 year (1 after day 30, 2 after day 90). One participant decided to terminate the study after day 30, prior to 90 day or 1 year assessments; this participant had not experienced clinical or biopsy-proven anitbody-mediated rejection at any time prior to termination.
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=14 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Development of de Novo Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody
Development within 90 days of vaccine
|
0 Participants
|
|
Development of de Novo Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody
Development within 1 year of vaccine
|
0 Participants
|
SECONDARY outcome
Timeframe: From study entry to 90 days post vaccine and up to 12-months post vaccinePopulation: Safety population (Participant receiving study vaccine). 3 participants terminated the study prior to 1 year (1 after day 30, 2 after day 90). One participant decided to terminate the study after day 30, prior to 90 day or 1 year assessments; this participant had not experienced clinical or biopsy-proven antibody-mediated rejection at any time prior to termination.
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=14 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Change in Pre-existing Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody
to 90 days post vaccine
|
0 Participants
|
|
Change in Pre-existing Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody
to 1 year post vaccine
|
0 Participants
|
SECONDARY outcome
Timeframe: At 30 days after the study dose of vaccinePopulation: Immunogenicity population (Participant receiving study vaccine, with baseline SARS-CoV-2 S anti-RBD assay ≤ 2500 U/ml). 1 participant received study vaccine but was excluded from immunogenicity population; baseline SARS-CoV-2 was initially misreported as eligible.
The antibody is measured by using the Roche Elecsys(R) anti-RBD assay
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=14 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Anti-RBD Antibody Concentration
|
565 U/ml
Interval 153.0 to 2038.0
|
SECONDARY outcome
Timeframe: From baseline to 30 days after the study dose of vaccinePopulation: 1 participant received study vaccine but was excluded from immunogenicity population; baseline SARS-CoV-2 was initially misreported as eligible (≤ 2500 U/ml).
The Fold Rise is the dimensionless ratio between each participant's day 30 antibody titer (in U/ml) and the participant's baseline antibody titer (in U/ml) antibody is the antibody titers are measured by using the Roche Elecsys(R) anti-RBD assay.
Outcome measures
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=14 Participants
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Fold Rise (FR) in Anti-RBD Antibody Concentration
|
1.8 ratio
Interval 1.2 to 3.4
|
SECONDARY outcome
Timeframe: At 14 and 30 days after the study vaccine dosePopulation: Data were not collected because tests were unable to be performed. Study funding was unexpectedly terminated prior to assessment of the samples. The assessment of these samples is not expected to be performed in the future.
For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability). tests unable to be performed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 14 and 30 days after the study vaccine dosePopulation: Data were not collected because tests were unable to be performed. Study funding was unexpectedly terminated prior to assessment of the samples. The assessment of these samples is not expected to be performed in the future.
For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability)
Outcome measures
Outcome data not reported
Adverse Events
SARS CoV-2 Anti-RBD Persistently Low
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 participants at risk
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Infections and infestations
COVID-19 infection
|
6.7%
1/15 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
Other adverse events
| Measure |
SARS CoV-2 Anti-RBD Persistently Low
n=15 participants at risk
Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
3/15 • Number of events 3 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
Blood and lymphatic system disorders
WBC disorder
|
20.0%
3/15 • Number of events 3 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
Endocrine disorders
Hyperglycaemia
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
Infections and infestations
Coronavirus infection
|
13.3%
2/15 • Number of events 2 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
Investigations
Blood creatinine increased
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
Investigations
Haemoglobin increased
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
13.3%
2/15 • Number of events 2 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
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Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
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Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
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Renal and urinary disorders
Nephropathy
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
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Respiratory, thoracic and mediastinal disorders
Cough
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6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
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Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
2/15 • Number of events 2 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
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Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
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6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
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Vascular disorders
Contusion
|
6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
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Vascular disorders
Dizziness
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6.7%
1/15 • Number of events 1 • Up to 1 year following the study dose of vaccine (See additional relevant information about adverse event collection in the Adverse Event Reporting Description).
Time frame for All-Cause mortality: up to 1 year following the study dose of vaccine. Time frame for SAEs and AESIs: up to 1 year following the study dose of vaccine. For this study, AESIs are the following: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; or potential Immune-Mediated Diseases (pIMD). Time frame for non-serious AEs: up to 30 days following the study dose of vaccine.
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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