Trial Outcomes & Findings for Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants (NCT NCT03928821)
NCT ID: NCT03928821
Last Updated: 2022-07-11
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Measured through 3 days after each vaccine dose at T1-T3: Day 0 and T4: Days 0, 112
Results posted on
2022-07-11
Participant Flow
Participant milestones
| Measure |
T1: PGT121 + VRC07-523LS mo 0
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
9
|
|
Overall Study
COMPLETED
|
6
|
3
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
3
|
1
|
Reasons for withdrawal
| Measure |
T1: PGT121 + VRC07-523LS mo 0
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
3
|
0
|
|
Overall Study
Participant Unable to Adhere to Visit Schedule
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants
Baseline characteristics by cohort
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
29 years
n=7 Participants
|
28 years
n=5 Participants
|
30 years
n=4 Participants
|
26 years
n=21 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
18 - 20 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Customized
21 - 30 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Customized
31 - 40 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Customized
41 - 50 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each vaccine dose at T1-T3: Day 0 and T4: Days 0, 112Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
None
|
5 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each vaccine dose at T1-T3: Day 0 and T4: Days 0, 112Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Gr 2: 5 to less than 10 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Gr 3: >=10 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Not Gradable
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Gr 1: 2.5 to less than 5 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Gr 3: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · None
|
6 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Not Gradable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Gr 1: 2.5 to less than 5 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Gr 3: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Gr 4: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · None
|
5 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Gr 2: 5 to less than 10 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Gr 3: >=10 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Gr 4: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
5 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Not Gradable
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 1: 2.5 to less than 5 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 2: 5 to less than 10 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: >=10 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 4: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each vaccine dose at T1-T3: Day 0 and T4: Days 0, 112Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · None
|
6 Participants
|
5 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
6 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized pruritus · None
|
6 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized pruritus · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized pruritus · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
3 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature (C) · None
|
6 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature (C) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature (C) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature (C) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature (C) · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
5 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized pruritus · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized pruritus · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
5 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
6 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased body temperature · None
|
6 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased body temperature · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased body temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased body temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased body temperature · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
5 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
1 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · None
|
6 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · None
|
6 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · None
|
6 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · None
|
6 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Baseline
|
15 U/L
Interval 14.0 to 20.0
|
14 U/L
Interval 12.0 to 15.0
|
13 U/L
Interval 10.0 to 17.0
|
14 U/L
Interval 12.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 0
|
14 U/L
Interval 8.0 to 17.0
|
12 U/L
Interval 10.0 to 17.0
|
13 U/L
Interval 10.0 to 16.0
|
14 U/L
Interval 10.0 to 16.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 14
|
14 U/L
Interval 13.0 to 15.0
|
16 U/L
Interval 11.0 to 21.0
|
11 U/L
Interval 10.0 to 12.0
|
12 U/L
Interval 10.0 to 16.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 56
|
13 U/L
Interval 9.0 to 19.0
|
15 U/L
Interval 11.0 to 21.0
|
20 U/L
Interval 12.0 to 21.0
|
16 U/L
Interval 13.0 to 17.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 84
|
—
|
—
|
—
|
13 U/L
Interval 12.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 112
|
17 U/L
Interval 8.0 to 23.0
|
9 U/L
Interval 9.0 to 27.0
|
16 U/L
Interval 14.0 to 17.0
|
15 U/L
Interval 11.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 140
|
—
|
—
|
—
|
18 U/L
Interval 9.0 to 20.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 168
|
14 U/L
Interval 8.0 to 24.0
|
11 U/L
Interval 10.0 to 16.0
|
17 U/L
Interval 16.0 to 18.0
|
17 U/L
Interval 17.0 to 17.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 224
|
24 U/L
Interval 24.0 to 24.0
|
12 U/L
Interval 12.0 to 12.0
|
—
|
14 U/L
Interval 10.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 280
|
—
|
12 U/L
Interval 12.0 to 12.0
|
13 U/L
Interval 11.0 to 27.0
|
14 U/L
Interval 10.0 to 17.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 336
|
18 U/L
Interval 15.0 to 22.0
|
8 U/L
Interval 7.0 to 9.0
|
14 U/L
Interval 13.0 to 23.0
|
16 U/L
Interval 11.0 to 19.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 392
|
—
|
—
|
—
|
15 U/L
Interval 13.0 to 18.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 448
|
—
|
—
|
—
|
14 U/L
Interval 11.0 to 18.0
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Baseline
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 14
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 56
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 84
|
—
|
—
|
—
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 112
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 140
|
—
|
—
|
—
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 168
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 0.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 224
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
—
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 280
|
—
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 336
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 392
|
—
|
—
|
—
|
1 mg/dL
Interval 1.0 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 448
|
—
|
—
|
—
|
1 mg/dL
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 336
|
13 g/dL
Interval 13.0 to 14.0
|
13 g/dL
Interval 12.0 to 14.0
|
13 g/dL
Interval 11.0 to 14.0
|
14 g/dL
Interval 13.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Baseline
|
14 g/dL
Interval 13.0 to 15.0
|
14 g/dL
Interval 13.0 to 14.0
|
15 g/dL
Interval 11.0 to 15.0
|
14 g/dL
Interval 13.0 to 14.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 0
|
13 g/dL
Interval 12.0 to 15.0
|
13 g/dL
Interval 13.0 to 14.0
|
13 g/dL
Interval 11.0 to 15.0
|
14 g/dL
Interval 13.0 to 14.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 14
|
13 g/dL
Interval 12.0 to 14.0
|
14 g/dL
Interval 13.0 to 15.0
|
13 g/dL
Interval 11.0 to 14.0
|
14 g/dL
Interval 12.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 56
|
13 g/dL
Interval 12.0 to 14.0
|
14 g/dL
Interval 13.0 to 15.0
|
14 g/dL
Interval 11.0 to 14.0
|
14 g/dL
Interval 13.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 84
|
—
|
—
|
—
|
15 g/dL
Interval 13.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 112
|
13 g/dL
Interval 13.0 to 15.0
|
13 g/dL
Interval 13.0 to 15.0
|
14 g/dL
Interval 11.0 to 14.0
|
13 g/dL
Interval 12.0 to 14.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 140
|
—
|
—
|
—
|
14 g/dL
Interval 13.0 to 14.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 168
|
13 g/dL
Interval 13.0 to 13.0
|
13 g/dL
Interval 13.0 to 14.0
|
14 g/dL
Interval 13.0 to 15.0
|
14 g/dL
Interval 14.0 to 14.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 224
|
13 g/dL
Interval 13.0 to 13.0
|
13 g/dL
Interval 13.0 to 13.0
|
—
|
14 g/dL
Interval 12.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 280
|
—
|
13 g/dL
Interval 13.0 to 13.0
|
12 g/dL
Interval 11.0 to 14.0
|
14 g/dL
Interval 13.0 to 14.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 392
|
—
|
—
|
—
|
14 g/dL
Interval 13.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 448
|
—
|
—
|
—
|
14 g/dL
Interval 13.0 to 15.0
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 14
|
1.63 1000 cells/cubic mm
Interval 1.3 to 1.719
|
1.781 1000 cells/cubic mm
Interval 1.528 to 1.95
|
1.54 1000 cells/cubic mm
Interval 1.385 to 2.279
|
1.99 1000 cells/cubic mm
Interval 1.58 to 2.69
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 56
|
1.824 1000 cells/cubic mm
Interval 1.375 to 1.982
|
1.667 1000 cells/cubic mm
Interval 1.59 to 1.84
|
1.723 1000 cells/cubic mm
Interval 1.36 to 2.033
|
2.176 1000 cells/cubic mm
Interval 1.72 to 2.24
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Baseline
|
1.65 1000 cells/cubic mm
Interval 1.33 to 2.13
|
2.191 1000 cells/cubic mm
Interval 1.67 to 2.46
|
1.551 1000 cells/cubic mm
Interval 0.89 to 1.946
|
2.31 1000 cells/cubic mm
Interval 1.48 to 2.605
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 0
|
1.778 1000 cells/cubic mm
Interval 1.13 to 2.18
|
1.785 1000 cells/cubic mm
Interval 1.618 to 2.2
|
1.445 1000 cells/cubic mm
Interval 1.32 to 1.612
|
1.802 1000 cells/cubic mm
Interval 1.68 to 2.17
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 84
|
—
|
—
|
—
|
1.83 1000 cells/cubic mm
Interval 1.761 to 2.27
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 112
|
1.693 1000 cells/cubic mm
Interval 1.2 to 2.255
|
1.768 1000 cells/cubic mm
Interval 1.529 to 1.9
|
1.22 1000 cells/cubic mm
Interval 1.21 to 2.048
|
2.002 1000 cells/cubic mm
Interval 1.55 to 2.14
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 140
|
—
|
—
|
—
|
1.487 1000 cells/cubic mm
Interval 1.4 to 1.67
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 168
|
1.688 1000 cells/cubic mm
Interval 1.465 to 2.009
|
2.015 1000 cells/cubic mm
Interval 1.97 to 2.42
|
1.918 1000 cells/cubic mm
Interval 1.405 to 2.195
|
1.65 1000 cells/cubic mm
Interval 1.64 to 1.66
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 224
|
1.02 1000 cells/cubic mm
Interval 1.02 to 1.02
|
2.9 1000 cells/cubic mm
Interval 2.9 to 2.9
|
—
|
2.015 1000 cells/cubic mm
Interval 1.5 to 2.16
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 280
|
—
|
2.14 1000 cells/cubic mm
Interval 2.14 to 2.14
|
1.563 1000 cells/cubic mm
Interval 1.32 to 1.93
|
1.74 1000 cells/cubic mm
Interval 1.49 to 2.22
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 336
|
1.651 1000 cells/cubic mm
Interval 1.26 to 1.762
|
1.764 1000 cells/cubic mm
Interval 1.72 to 1.807
|
1.927 1000 cells/cubic mm
Interval 1.288 to 2.035
|
1.898 1000 cells/cubic mm
Interval 1.675 to 2.1
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 392
|
—
|
—
|
—
|
1.849 1000 cells/cubic mm
Interval 1.74 to 2.15
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 448
|
—
|
—
|
—
|
1.76 1000 cells/cubic mm
Interval 1.57 to 2.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Baseline
|
3.338 1000 cells/cubic mm
Interval 3.072 to 4.602
|
3.56 1000 cells/cubic mm
Interval 3.227 to 3.71
|
3.39 1000 cells/cubic mm
Interval 2.46 to 3.962
|
4.194 1000 cells/cubic mm
Interval 2.97 to 5.97
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 0
|
3.307 1000 cells/cubic mm
Interval 2.616 to 3.91
|
3.032 1000 cells/cubic mm
Interval 2.5 to 3.856
|
2.962 1000 cells/cubic mm
Interval 2.88 to 4.8
|
4.3 1000 cells/cubic mm
Interval 3.42 to 5.32
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 14
|
3.181 1000 cells/cubic mm
Interval 2.573 to 3.382
|
4.037 1000 cells/cubic mm
Interval 3.71 to 4.395
|
4.024 1000 cells/cubic mm
Interval 3.135 to 4.73
|
4.831 1000 cells/cubic mm
Interval 3.7 to 5.05
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 56
|
2.762 1000 cells/cubic mm
Interval 2.655 to 3.36
|
3.581 1000 cells/cubic mm
Interval 2.67 to 4.68
|
3.55 1000 cells/cubic mm
Interval 3.235 to 4.082
|
4.98 1000 cells/cubic mm
Interval 4.07 to 5.624
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 84
|
—
|
—
|
—
|
4.12 1000 cells/cubic mm
Interval 3.22 to 5.48
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 112
|
3.377 1000 cells/cubic mm
Interval 2.654 to 3.714
|
3.22 1000 cells/cubic mm
Interval 2.86 to 3.98
|
2.944 1000 cells/cubic mm
Interval 2.39 to 3.66
|
3.735 1000 cells/cubic mm
Interval 2.42 to 4.181
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 140
|
—
|
—
|
—
|
4.108 1000 cells/cubic mm
Interval 2.45 to 4.47
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 168
|
3.882 1000 cells/cubic mm
Interval 3.524 to 4.208
|
4.285 1000 cells/cubic mm
Interval 2.31 to 6.16
|
3.272 1000 cells/cubic mm
Interval 2.662 to 3.479
|
3.155 1000 cells/cubic mm
Interval 2.63 to 3.68
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 224
|
5.24 1000 cells/cubic mm
Interval 5.24 to 5.24
|
3.38 1000 cells/cubic mm
Interval 3.38 to 3.38
|
—
|
2.855 1000 cells/cubic mm
Interval 2.73 to 4.77
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 280
|
—
|
3.35 1000 cells/cubic mm
Interval 3.35 to 3.35
|
3.922 1000 cells/cubic mm
Interval 3.112 to 4.357
|
4.14 1000 cells/cubic mm
Interval 2.02 to 5.257
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 336
|
3.93 1000 cells/cubic mm
Interval 2.672 to 3.994
|
2.858 1000 cells/cubic mm
Interval 2.72 to 2.995
|
2.315 1000 cells/cubic mm
Interval 1.9 to 4.752
|
3 1000 cells/cubic mm
Interval 2.88 to 4.868
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 392
|
—
|
—
|
—
|
3.565 1000 cells/cubic mm
Interval 2.68 to 5.25
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 448
|
—
|
—
|
—
|
3.81 1000 cells/cubic mm
Interval 2.99 to 5.491
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 168
|
208 1000 cells/cubic mm
Interval 155.5 to 248.0
|
380 1000 cells/cubic mm
Interval 265.0 to 403.0
|
239 1000 cells/cubic mm
Interval 176.0 to 301.5
|
159 1000 cells/cubic mm
Interval 127.0 to 191.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 280
|
—
|
361 1000 cells/cubic mm
Interval 361.0 to 361.0
|
218 1000 cells/cubic mm
Interval 134.0 to 293.0
|
254 1000 cells/cubic mm
Interval 234.0 to 279.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 336
|
233 1000 cells/cubic mm
Interval 189.0 to 258.5
|
373.5 1000 cells/cubic mm
Interval 373.0 to 374.0
|
249 1000 cells/cubic mm
Interval 129.0 to 314.0
|
242 1000 cells/cubic mm
Interval 234.5 to 267.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 392
|
—
|
—
|
—
|
264.5 1000 cells/cubic mm
Interval 212.0 to 288.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 448
|
—
|
—
|
—
|
246 1000 cells/cubic mm
Interval 227.0 to 296.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Baseline
|
6.25 1000 cells/cubic mm
Interval 5.5 to 7.54
|
6.615 1000 cells/cubic mm
Interval 5.4 to 6.9
|
5.6 1000 cells/cubic mm
Interval 4.63 to 6.4
|
6.1 1000 cells/cubic mm
Interval 5.9 to 9.61
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 0
|
6.145 1000 cells/cubic mm
Interval 5.2 to 6.46
|
5.665 1000 cells/cubic mm
Interval 5.33 to 6.8
|
5.4 1000 cells/cubic mm
Interval 4.83 to 6.76
|
6.53 1000 cells/cubic mm
Interval 6.3 to 8.2
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 14
|
5.55 1000 cells/cubic mm
Interval 4.9 to 6.34
|
6.645 1000 cells/cubic mm
Interval 5.8 to 6.8
|
6.27 1000 cells/cubic mm
Interval 5.5 to 6.87
|
7.49 1000 cells/cubic mm
Interval 5.9 to 7.7
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 56
|
5.25 1000 cells/cubic mm
Interval 5.1 to 6.5
|
5.985 1000 cells/cubic mm
Interval 5.7 to 7.29
|
5.6 1000 cells/cubic mm
Interval 5.47 to 6.5
|
7.8 1000 cells/cubic mm
Interval 7.6 to 8.6
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 84
|
—
|
—
|
—
|
6.5 1000 cells/cubic mm
Interval 6.3 to 8.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 112
|
5.85 1000 cells/cubic mm
Interval 5.4 to 6.78
|
6.4 1000 cells/cubic mm
Interval 5.2 to 6.76
|
4.9 1000 cells/cubic mm
Interval 4.6 to 6.87
|
6.15 1000 cells/cubic mm
Interval 5.26 to 6.9
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 140
|
—
|
—
|
—
|
6.3 1000 cells/cubic mm
Interval 4.3 to 6.7
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 168
|
6.29 1000 cells/cubic mm
Interval 6.19 to 6.42
|
6.9 1000 cells/cubic mm
Interval 5.77 to 9.15
|
5.35 1000 cells/cubic mm
Interval 5.15 to 5.78
|
5.35 1000 cells/cubic mm
Interval 4.8 to 5.9
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 224
|
6.93 1000 cells/cubic mm
Interval 6.93 to 6.93
|
7.07 1000 cells/cubic mm
Interval 7.07 to 7.07
|
—
|
5.6 1000 cells/cubic mm
Interval 4.8 to 7.5
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 280
|
—
|
6.24 1000 cells/cubic mm
Interval 6.24 to 6.24
|
5.9 1000 cells/cubic mm
Interval 5.37 to 6.515
|
6.2 1000 cells/cubic mm
Interval 4.2 to 8.1
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 336
|
5.9 1000 cells/cubic mm
Interval 4.6 to 6.4
|
5.18 1000 cells/cubic mm
Interval 5.06 to 5.3
|
5.1 1000 cells/cubic mm
Interval 3.8 to 7.3
|
5.76 1000 cells/cubic mm
Interval 5.25 to 7.4
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 392
|
—
|
—
|
—
|
6.25 1000 cells/cubic mm
Interval 5.6 to 7.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 448
|
—
|
—
|
—
|
6.2 1000 cells/cubic mm
Interval 5.2 to 7.5
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Baseline
|
219.5 1000 cells/cubic mm
Interval 200.0 to 259.0
|
303 1000 cells/cubic mm
Interval 265.0 to 346.0
|
245.5 1000 cells/cubic mm
Interval 158.0 to 299.0
|
248 1000 cells/cubic mm
Interval 209.0 to 269.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 0
|
217 1000 cells/cubic mm
Interval 193.0 to 245.0
|
317 1000 cells/cubic mm
Interval 244.0 to 328.0
|
241.5 1000 cells/cubic mm
Interval 156.0 to 292.0
|
267 1000 cells/cubic mm
Interval 246.0 to 274.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 14
|
218.5 1000 cells/cubic mm
Interval 189.0 to 242.0
|
291 1000 cells/cubic mm
Interval 228.0 to 338.0
|
244.5 1000 cells/cubic mm
Interval 168.0 to 314.0
|
250 1000 cells/cubic mm
Interval 241.0 to 296.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 56
|
228.5 1000 cells/cubic mm
Interval 198.0 to 242.0
|
327.5 1000 cells/cubic mm
Interval 258.0 to 346.0
|
278 1000 cells/cubic mm
Interval 189.0 to 346.0
|
288 1000 cells/cubic mm
Interval 244.0 to 302.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 84
|
—
|
—
|
—
|
259 1000 cells/cubic mm
Interval 250.0 to 281.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 112
|
221.5 1000 cells/cubic mm
Interval 205.0 to 247.0
|
349 1000 cells/cubic mm
Interval 272.0 to 377.0
|
259 1000 cells/cubic mm
Interval 204.0 to 297.0
|
243 1000 cells/cubic mm
Interval 214.0 to 297.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 140
|
—
|
—
|
—
|
195 1000 cells/cubic mm
Interval 174.0 to 289.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 224
|
158 1000 cells/cubic mm
Interval 158.0 to 158.0
|
336 1000 cells/cubic mm
Interval 336.0 to 336.0
|
—
|
250.5 1000 cells/cubic mm
Interval 227.0 to 264.0
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, 448*, and 504* Days with * are only available for T4Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 336
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 392
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 14
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 56
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 336
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 392
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 336
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 392
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 336
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 392
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 56
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 112
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 168
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 280
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 336
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 392
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 336
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 392
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 336
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 392
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 4Population: Safety population
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm. The three participants discontinued treatment in T4 were due to the COVID-19 pandemic lockdown.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Participant unable to schedule visit within window
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Unable to contact participant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Incarceration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Other
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Did not Discontinue SPA
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Pregnancy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
HIV infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Clinical event other than reactogenicity, HIV infection, or death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Solicited adverse event symptom
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Investigator Reason
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Participant refused SPA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Co-Enrollment in a study with an investigational research agent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Psychiatric reason
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured during Screening, Days 0, 3, 6, 14, 28, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448* Days with * are only available for T4Population: T1-T3 particiants who received infusion at Day 0 and T4 participants who received infusions at Day 0 and 112 with available serum concentration data. Visits with 0 participants analyzed are due to: (1) mAbs were only assayed for the treatment arms that received those mAbs. (2) Treatment group T4 had more scheduled sample collection visits than treatment groups T1-T3. (3) Data were excluded if the participant didn't receive all scheduled administrations.
Serum PGDM1400, PGT121, and VRC07-523LS IgG levels were measured on a Bio-Plex instrument (Bio-Rad) using a validated assay designed to simultaneously measure infused PGDM1400, PGT121, and VRC07-523LS by its ability to bind anti-idiotype antibody captured on fluorescent magnetic beads. This assay was derived from a standardized custom HIV-1 Luminex assay. PGDM1400, PGT121 and VRC07-523LS were titrated and combined to create a standard curve that was used to determine concentration of the diluted samples. The negative controls were CH58 (an irrelevant mAb) and blank beads.Serum 10-1074 level was measured by anti-idotypic ELISA. Participant serum sample was incubated in anti-ID coated micro-plate well. A conjugated secondary antibody was used to detect bound 10-1074. Samples were titrated to ensure positive optical density (O.D.) readouts fall within the linear range of the assay for monoclonal antibody concentration calculations.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
10-1074 (Day- 0)
|
—
|
—
|
0.21 mg/ml
Interval 0.21 to 0.21
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
10-1074 (Day- 6)
|
—
|
—
|
453.99 mg/ml
Interval 378.63 to 529.19
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
10-1074 (Day- 14)
|
—
|
—
|
300.15 mg/ml
Interval 279.57 to 315.65
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
10-1074 (Day- 28)
|
—
|
—
|
242.22 mg/ml
Interval 140.97 to 253.34
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
10-1074 (Day- 56)
|
—
|
—
|
111.62 mg/ml
Interval 81.11 to 127.39
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
10-1074 (Day-112)
|
—
|
—
|
25.18 mg/ml
Interval 19.22 to 32.51
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
10-1074 (Day-168)
|
—
|
—
|
8.60 mg/ml
Interval 6.27 to 11.17
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
10-1074 (Day-280)
|
—
|
—
|
0.98 mg/ml
Interval 0.59 to 3.25
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
10-1074 (Day-336)
|
—
|
—
|
2.44 mg/ml
Interval 1.32 to 3.55
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day- 0)
|
—
|
0.02 mg/ml
Interval 0.02 to 0.02
|
—
|
0.02 mg/ml
Interval 0.02 to 0.02
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day- 3)
|
—
|
251.54 mg/ml
Interval 234.47 to 273.48
|
—
|
209.25 mg/ml
Interval 191.7 to 315.97
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day- 6)
|
—
|
182.23 mg/ml
Interval 160.51 to 186.36
|
—
|
172.18 mg/ml
Interval 163.04 to 193.95
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day- 14)
|
—
|
139.77 mg/ml
Interval 134.94 to 146.76
|
—
|
129.97 mg/ml
Interval 116.59 to 143.36
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day- 28)
|
—
|
70.92 mg/ml
Interval 67.17 to 73.87
|
—
|
67.59 mg/ml
Interval 55.45 to 75.91
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day- 56)
|
—
|
27.88 mg/ml
Interval 26.68 to 31.56
|
—
|
28.38 mg/ml
Interval 18.02 to 39.5
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day- 84)
|
—
|
—
|
—
|
10.93 mg/ml
Interval 7.79 to 14.97
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day-112)
|
—
|
5.50 mg/ml
Interval 4.63 to 6.04
|
—
|
4.99 mg/ml
Interval 3.81 to 7.11
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day-140)
|
—
|
—
|
—
|
46.07 mg/ml
Interval 46.07 to 46.07
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day-168)
|
—
|
1.08 mg/ml
Interval 1.02 to 1.1
|
—
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day-224)
|
—
|
0.26 mg/ml
Interval 0.26 to 0.26
|
—
|
6.24 mg/ml
Interval 4.22 to 9.12
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day-280)
|
—
|
0.09 mg/ml
Interval 0.09 to 0.09
|
—
|
1.27 mg/ml
Interval 0.5 to 1.55
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day-336)
|
—
|
0.02 mg/ml
Interval 0.02 to 0.02
|
—
|
0.52 mg/ml
Interval 0.18 to 0.67
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day-392)
|
—
|
—
|
—
|
0.11 mg/ml
Interval 0.04 to 0.12
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400 (Day-448)
|
—
|
—
|
—
|
0.02 mg/ml
Interval 0.02 to 0.04
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day- 0)
|
0.05 mg/ml
Interval 0.05 to 0.05
|
—
|
—
|
0.05 mg/ml
Interval 0.05 to 0.05
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day- 3)
|
196.57 mg/ml
Interval 172.85 to 210.31
|
—
|
—
|
169.62 mg/ml
Interval 153.15 to 218.39
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day- 6)
|
129.35 mg/ml
Interval 116.95 to 137.34
|
—
|
—
|
130.33 mg/ml
Interval 128.4 to 139.89
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day- 14)
|
80.12 mg/ml
Interval 79.07 to 86.22
|
—
|
—
|
95.54 mg/ml
Interval 90.48 to 101.27
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day- 28)
|
44.46 mg/ml
Interval 40.81 to 50.03
|
—
|
—
|
60.62 mg/ml
Interval 54.15 to 68.21
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day- 56)
|
22.08 mg/ml
Interval 18.83 to 23.24
|
—
|
—
|
25.79 mg/ml
Interval 16.64 to 30.72
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day- 84)
|
—
|
—
|
—
|
12.42 mg/ml
Interval 9.09 to 15.18
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day-112)
|
4.03 mg/ml
Interval 3.45 to 5.97
|
—
|
—
|
5.82 mg/ml
Interval 5.6 to 10.02
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day-140)
|
—
|
—
|
—
|
49.17 mg/ml
Interval 49.17 to 49.17
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day-168)
|
1.70 mg/ml
Interval 0.88 to 3.28
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day-224)
|
0.31 mg/ml
Interval 0.31 to 0.31
|
—
|
—
|
11.28 mg/ml
Interval 7.72 to 12.63
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day-280)
|
—
|
—
|
—
|
2.36 mg/ml
Interval 1.46 to 4.57
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day-336)
|
0.05 mg/ml
Interval 0.05 to 0.11
|
—
|
—
|
1.05 mg/ml
Interval 0.56 to 2.06
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day-392)
|
—
|
—
|
—
|
0.33 mg/ml
Interval 0.17 to 0.65
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
PGT121 (Day-448)
|
—
|
—
|
—
|
0.10 mg/ml
Interval 0.05 to 0.29
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day- 0)
|
0.01 mg/ml
Interval 0.01 to 0.02
|
0.01 mg/ml
Interval 0.01 to 0.01
|
0.01 mg/ml
Interval 0.01 to 0.01
|
0.01 mg/ml
Interval 0.01 to 0.01
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day- 3)
|
265.97 mg/ml
Interval 262.58 to 300.62
|
239.32 mg/ml
Interval 224.13 to 264.34
|
182.66 mg/ml
Interval 164.8 to 187.4
|
212.11 mg/ml
Interval 195.83 to 306.56
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day- 6)
|
171.02 mg/ml
Interval 158.01 to 209.24
|
176.51 mg/ml
Interval 158.5 to 183.85
|
176.01 mg/ml
Interval 167.23 to 176.82
|
156.15 mg/ml
Interval 154.76 to 175.84
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day- 14)
|
134.44 mg/ml
Interval 128.24 to 135.66
|
139.18 mg/ml
Interval 105.71 to 155.86
|
119.67 mg/ml
Interval 90.44 to 145.1
|
140.86 mg/ml
Interval 123.89 to 162.85
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day- 28)
|
94.58 mg/ml
Interval 88.61 to 102.26
|
96.17 mg/ml
Interval 83.8 to 110.65
|
87.91 mg/ml
Interval 85.13 to 96.66
|
101.42 mg/ml
Interval 97.05 to 107.31
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day- 56)
|
60.53 mg/ml
Interval 55.78 to 62.7
|
56.91 mg/ml
Interval 56.03 to 58.35
|
59.33 mg/ml
Interval 51.36 to 63.18
|
56.94 mg/ml
Interval 42.61 to 63.36
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day- 84)
|
—
|
—
|
—
|
39.57 mg/ml
Interval 28.79 to 45.09
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day-112)
|
24.93 mg/ml
Interval 20.69 to 26.88
|
31.65 mg/ml
Interval 20.09 to 33.07
|
29.37 mg/ml
Interval 24.02 to 30.69
|
26.07 mg/ml
Interval 19.85 to 33.7
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day-140)
|
—
|
—
|
—
|
76.03 mg/ml
Interval 76.03 to 76.03
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day-168)
|
14.45 mg/ml
Interval 12.37 to 16.66
|
12.57 mg/ml
Interval 10.74 to 14.17
|
11.57 mg/ml
Interval 9.73 to 12.35
|
—
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day-224)
|
8.47 mg/ml
Interval 8.47 to 8.47
|
11.24 mg/ml
Interval 11.24 to 11.24
|
—
|
39.86 mg/ml
Interval 31.26 to 42.29
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day-280)
|
—
|
3.88 mg/ml
Interval 3.88 to 3.88
|
3.17 mg/ml
Interval 1.81 to 3.5
|
15.13 mg/ml
Interval 14.85 to 16.5
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day-336)
|
1.33 mg/ml
Interval 1.08 to 1.38
|
1.31 mg/ml
Interval 1.16 to 1.46
|
1.48 mg/ml
Interval 0.85 to 2.34
|
9.52 mg/ml
Interval 6.85 to 10.98
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day-392)
|
—
|
—
|
—
|
4.49 mg/ml
Interval 2.73 to 5.51
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS (Day-448)
|
—
|
—
|
—
|
2.16 mg/ml
Interval 1.1 to 2.59
|
|
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
10-1074 (Day- 3)
|
—
|
—
|
598.55 mg/ml
Interval 444.43 to 844.87
|
—
|
SECONDARY outcome
Timeframe: Measured during Screening, Days 0, 3, 28, 56, 112, 140*, 168*, 224* Days with * are only available for T4Population: T1-T3 particiants who received infusion at Day 0 and T4 participants who received infusions at Day 0 and 112 with available neutralizing antibody data. Visits with 0 participants are due to: (1) Isolates were mAb-specific and only assayed for the treatment arms that received the specific mAbs. (2) Treatment group T4 had more scheduled sample collection visits than treatment groups T1-T3. (3) Data were excluded if the participant didn't receive all scheduled administrations.
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped viruses sensitive to the bnAbs (i.e., bnAb-specific viruses) in each infusion group.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
T250-4 (Day-112)
|
300.37 Relative luminescence units (RLU)
Interval 266.45 to 650.96
|
800.00 Relative luminescence units (RLU)
Interval 618.17 to 837.77
|
1189.03 Relative luminescence units (RLU)
Interval 760.3 to 1712.31
|
—
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
6540.v4.c1 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
6540.v4.c1 (Day- 3)
|
—
|
—
|
—
|
12301.30 Relative luminescence units (RLU)
Interval 9796.41 to 17398.1
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
6540.v4.c1 (Day- 28)
|
—
|
—
|
—
|
2365.28 Relative luminescence units (RLU)
Interval 1930.73 to 2730.45
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
6540.v4.c1 (Day- 56)
|
—
|
—
|
—
|
674.62 Relative luminescence units (RLU)
Interval 512.44 to 784.11
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
6540.v4.c1 (Day-112)
|
—
|
—
|
—
|
82.11 Relative luminescence units (RLU)
Interval 61.03 to 98.13
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
6540.v4.c1 (Day-140)
|
—
|
—
|
—
|
1255.62 Relative luminescence units (RLU)
Interval 1255.62 to 1255.62
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
6540.v4.c1 (Day-224)
|
—
|
—
|
—
|
64.76 Relative luminescence units (RLU)
Interval 46.21 to 113.02
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CH505TF.N334S.N160A.N280D.1 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CH505TF.N334S.N160A.N280D.1 (Day- 3)
|
—
|
—
|
—
|
13209.26 Relative luminescence units (RLU)
Interval 9855.8 to 16397.4
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CH505TF.N334S.N160A.N280D.1 (Day- 28)
|
—
|
—
|
—
|
3344.91 Relative luminescence units (RLU)
Interval 2579.95 to 3806.03
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CH505TF.N334S.N160A.N280D.1 (Day- 56)
|
—
|
—
|
—
|
1491.45 Relative luminescence units (RLU)
Interval 901.81 to 1966.97
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CH505TF.N334S.N160A.N280D.1 (Day-112)
|
—
|
—
|
—
|
339.83 Relative luminescence units (RLU)
Interval 296.59 to 554.03
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CH505TF.N334S.N160A.N280D.1 (Day-140)
|
—
|
—
|
—
|
2563.08 Relative luminescence units (RLU)
Interval 2563.08 to 2563.08
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CH505TF.N334S.N160A.N280D.1 (Day-224)
|
—
|
—
|
—
|
429.44 Relative luminescence units (RLU)
Interval 318.03 to 585.79
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CNE55.N160K (Day- 0)
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CNE55.N160K (Day- 3)
|
917.25 Relative luminescence units (RLU)
Interval 686.59 to 1286.7
|
816.88 Relative luminescence units (RLU)
Interval 725.91 to 847.67
|
493.12 Relative luminescence units (RLU)
Interval 383.85 to 549.58
|
469.12 Relative luminescence units (RLU)
Interval 432.41 to 868.21
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CNE55.N160K (Day- 28)
|
259.58 Relative luminescence units (RLU)
Interval 212.45 to 323.5
|
188.55 Relative luminescence units (RLU)
Interval 161.5 to 208.8
|
206.12 Relative luminescence units (RLU)
Interval 171.05 to 268.36
|
218.32 Relative luminescence units (RLU)
Interval 169.74 to 257.46
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CNE55.N160K (Day- 56)
|
105.02 Relative luminescence units (RLU)
Interval 91.83 to 118.53
|
91.57 Relative luminescence units (RLU)
Interval 80.4 to 117.12
|
170.55 Relative luminescence units (RLU)
Interval 138.0 to 193.64
|
131.99 Relative luminescence units (RLU)
Interval 106.91 to 149.44
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CNE55.N160K (Day-112)
|
28.65 Relative luminescence units (RLU)
Interval 25.1 to 36.11
|
10.00 Relative luminescence units (RLU)
Interval 10.0 to 20.95
|
53.48 Relative luminescence units (RLU)
Interval 38.18 to 59.63
|
47.57 Relative luminescence units (RLU)
Interval 30.49 to 65.17
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CNE55.N160K (Day-140)
|
—
|
—
|
—
|
92.76 Relative luminescence units (RLU)
Interval 92.76 to 92.76
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
CNE55.N160K (Day-224)
|
—
|
—
|
—
|
58.52 Relative luminescence units (RLU)
Interval 48.16 to 82.07
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
T250-4 (Day- 0)
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
—
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
T250-4 (Day- 3)
|
32029.39 Relative luminescence units (RLU)
Interval 28181.95 to 41032.5
|
91301.02 Relative luminescence units (RLU)
Interval 79640.01 to
|
39113.31 Relative luminescence units (RLU)
Interval 31644.98 to 45736.7
|
—
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
T250-4 (Day- 28)
|
6458.16 Relative luminescence units (RLU)
Interval 5518.54 to 7452.56
|
27318.99 Relative luminescence units (RLU)
Interval 23401.71 to 30312.3
|
13028.85 Relative luminescence units (RLU)
Interval 11586.88 to 14345.8
|
—
|
|
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
T250-4 (Day- 56)
|
2016.84 Relative luminescence units (RLU)
Interval 1800.34 to 2646.68
|
7523.58 Relative luminescence units (RLU)
Interval 6020.17 to 8716.04
|
7070.48 Relative luminescence units (RLU)
Interval 5359.84 to 7736.68
|
—
|
SECONDARY outcome
Timeframe: Measured during Screening, Days 0, 3, 6, 14, 28, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448* Days with * are only available for T4Population: All participants enrolled with available serum concentration data. Visits with 0 participants are due to: (1) mAbs were only assayed for the treatment arms that received those mAbs. (2) Treatment group T4 had more scheduled sample collection visits than treatment groups T1-T3.
Serum PGDM1400, PGT121, and VRC07-523LS IgG levels were measured on a Bio-Plex instrument (Bio-Rad) using a validated assay designed to simultaneously measure infused PGDM1400, PGT121, and VRC07-523LS by its ability to bind anti-idiotype antibody captured on fluorescent magnetic beads. This assay was derived from a standardized custom HIV-1 Luminex assay. PGDM1400, PGT121 and VRC07-523LS were titrated and combined to create a standard curve that was used to determine concentration of the diluted samples. The negative controls were CH58 (an irrelevant mAb) and blank beads.Serum 10-1074 level was measured by anti-idotypic ELISA. Participant serum sample was incubated in anti-ID coated micro-plate well. A conjugated secondary antibody was used to detect bound 10-1074. Samples were titrated to ensure positive optical density (O.D.) readouts fall within the linear range of the assay for monoclonal antibody concentration calculations
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
10-1074 (Day- 0)
|
—
|
—
|
0.21 mg/ml
Interval 0.21 to 0.21
|
—
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
10-1074 (Day- 3)
|
—
|
—
|
521.49 mg/ml
Interval 422.63 to 783.29
|
—
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
10-1074 (Day- 6)
|
—
|
—
|
416.31 mg/ml
Interval 298.03 to 510.39
|
—
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
10-1074 (Day- 14)
|
—
|
—
|
289.86 mg/ml
Interval 207.92 to 311.78
|
—
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
10-1074 (Day- 28)
|
—
|
—
|
242.22 mg/ml
Interval 140.97 to 253.34
|
—
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
10-1074 (Day- 56)
|
—
|
—
|
98.27 mg/ml
Interval 29.65 to 124.97
|
—
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
10-1074 (Day-112)
|
—
|
—
|
23.96 mg/ml
Interval 8.04 to 26.39
|
—
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
10-1074 (Day-168)
|
—
|
—
|
8.60 mg/ml
Interval 6.27 to 11.17
|
—
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
10-1074 (Day-280)
|
—
|
—
|
0.59 mg/ml
Interval 0.21 to 2.11
|
—
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
10-1074 (Day-336)
|
—
|
—
|
2.44 mg/ml
Interval 1.32 to 3.55
|
—
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day- 0)
|
—
|
0.02 mg/ml
Interval 0.02 to 0.02
|
—
|
0.02 mg/ml
Interval 0.02 to 0.02
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day- 3)
|
—
|
251.54 mg/ml
Interval 234.47 to 273.48
|
—
|
231.33 mg/ml
Interval 203.73 to 319.27
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day- 6)
|
—
|
182.23 mg/ml
Interval 160.51 to 186.36
|
—
|
173.81 mg/ml
Interval 168.63 to 177.65
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day- 14)
|
—
|
139.77 mg/ml
Interval 134.94 to 146.76
|
—
|
126.56 mg/ml
Interval 113.27 to 146.69
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day- 28)
|
—
|
70.92 mg/ml
Interval 67.17 to 73.87
|
—
|
71.60 mg/ml
Interval 52.74 to 77.35
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day- 56)
|
—
|
27.88 mg/ml
Interval 26.68 to 31.56
|
—
|
33.70 mg/ml
Interval 19.33 to 39.98
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day- 84)
|
—
|
—
|
—
|
12.26 mg/ml
Interval 7.2 to 15.87
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day-112)
|
—
|
5.50 mg/ml
Interval 4.63 to 6.04
|
—
|
4.99 mg/ml
Interval 3.81 to 7.11
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day-140)
|
—
|
—
|
—
|
3.49 mg/ml
Interval 2.34 to 24.78
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day-168)
|
—
|
1.08 mg/ml
Interval 1.02 to 1.1
|
—
|
1.51 mg/ml
Interval 1.14 to 1.88
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day-224)
|
—
|
0.26 mg/ml
Interval 0.26 to 0.26
|
—
|
2.21 mg/ml
Interval 0.88 to 6.24
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day-280)
|
—
|
0.09 mg/ml
Interval 0.09 to 0.09
|
—
|
0.50 mg/ml
Interval 0.23 to 1.41
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day-336)
|
—
|
0.02 mg/ml
Interval 0.02 to 0.02
|
—
|
0.25 mg/ml
Interval 0.08 to 0.65
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day-392)
|
—
|
—
|
—
|
0.04 mg/ml
Interval 0.02 to 0.11
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGDM1400 (Day-448)
|
—
|
—
|
—
|
0.02 mg/ml
Interval 0.02 to 0.03
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day- 0)
|
0.05 mg/ml
Interval 0.05 to 0.05
|
—
|
—
|
0.05 mg/ml
Interval 0.05 to 0.05
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day- 3)
|
196.57 mg/ml
Interval 172.85 to 210.31
|
—
|
—
|
181.38 mg/ml
Interval 157.86 to 219.1
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day- 6)
|
129.35 mg/ml
Interval 116.95 to 137.34
|
—
|
—
|
130.98 mg/ml
Interval 128.1 to 137.61
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day- 14)
|
80.12 mg/ml
Interval 79.07 to 86.22
|
—
|
—
|
90.47 mg/ml
Interval 84.84 to 100.59
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day- 28)
|
44.46 mg/ml
Interval 40.81 to 50.03
|
—
|
—
|
56.75 mg/ml
Interval 45.47 to 64.49
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day- 56)
|
22.08 mg/ml
Interval 18.83 to 23.24
|
—
|
—
|
29.32 mg/ml
Interval 19.33 to 31.85
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day- 84)
|
—
|
—
|
—
|
15.00 mg/ml
Interval 8.83 to 16.35
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day-112)
|
4.03 mg/ml
Interval 3.45 to 5.97
|
—
|
—
|
5.82 mg/ml
Interval 5.6 to 10.02
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day-140)
|
—
|
—
|
—
|
6.08 mg/ml
Interval 4.06 to 27.62
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day-168)
|
1.70 mg/ml
Interval 0.88 to 3.28
|
—
|
—
|
2.72 mg/ml
Interval 2.02 to 3.41
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day-224)
|
0.31 mg/ml
Interval 0.31 to 0.31
|
—
|
—
|
4.16 mg/ml
Interval 2.08 to 11.28
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day-280)
|
—
|
—
|
—
|
1.46 mg/ml
Interval 0.74 to 3.46
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day-336)
|
0.05 mg/ml
Interval 0.05 to 0.11
|
—
|
—
|
0.71 mg/ml
Interval 0.34 to 1.43
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day-392)
|
—
|
—
|
—
|
0.18 mg/ml
Interval 0.14 to 0.49
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
PGT121 (Day-448)
|
—
|
—
|
—
|
0.05 mg/ml
Interval 0.05 to 0.19
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day- 0)
|
0.01 mg/ml
Interval 0.01 to 0.02
|
0.01 mg/ml
Interval 0.01 to 0.01
|
0.01 mg/ml
Interval 0.01 to 0.01
|
0.01 mg/ml
Interval 0.01 to 0.01
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day- 3)
|
265.97 mg/ml
Interval 262.58 to 300.62
|
239.32 mg/ml
Interval 224.13 to 264.34
|
173.73 mg/ml
Interval 145.91 to 186.22
|
230.06 mg/ml
Interval 199.85 to 333.96
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day- 6)
|
171.02 mg/ml
Interval 158.01 to 209.24
|
176.51 mg/ml
Interval 158.5 to 183.85
|
171.62 mg/ml
Interval 164.76 to 176.61
|
169.54 mg/ml
Interval 155.85 to 182.3
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day- 14)
|
134.44 mg/ml
Interval 128.24 to 135.66
|
139.18 mg/ml
Interval 105.71 to 155.86
|
105.05 mg/ml
Interval 85.34 to 138.74
|
133.03 mg/ml
Interval 120.16 to 146.62
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day- 28)
|
94.58 mg/ml
Interval 88.61 to 102.26
|
96.17 mg/ml
Interval 83.8 to 110.65
|
87.91 mg/ml
Interval 85.13 to 96.66
|
96.52 mg/ml
Interval 94.26 to 104.18
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day- 56)
|
60.53 mg/ml
Interval 55.78 to 62.7
|
56.91 mg/ml
Interval 56.03 to 58.35
|
56.91 mg/ml
Interval 34.69 to 61.74
|
60.24 mg/ml
Interval 53.64 to 67.05
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day- 84)
|
—
|
—
|
—
|
41.64 mg/ml
Interval 31.11 to 44.37
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day-112)
|
24.93 mg/ml
Interval 20.69 to 26.88
|
31.65 mg/ml
Interval 20.09 to 33.07
|
28.18 mg/ml
Interval 11.53 to 30.55
|
26.07 mg/ml
Interval 19.85 to 33.7
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day-140)
|
—
|
—
|
—
|
13.94 mg/ml
Interval 13.09 to 44.99
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day-168)
|
14.45 mg/ml
Interval 12.37 to 16.66
|
12.57 mg/ml
Interval 10.74 to 14.17
|
11.57 mg/ml
Interval 9.73 to 12.35
|
9.98 mg/ml
Interval 9.46 to 10.5
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day-224)
|
8.47 mg/ml
Interval 8.47 to 8.47
|
11.24 mg/ml
Interval 11.24 to 11.24
|
—
|
22.66 mg/ml
Interval 5.51 to 39.86
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day-280)
|
—
|
3.88 mg/ml
Interval 3.88 to 3.88
|
1.81 mg/ml
Interval 0.34 to 3.33
|
14.85 mg/ml
Interval 5.99 to 15.82
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day-336)
|
1.33 mg/ml
Interval 1.08 to 1.38
|
1.31 mg/ml
Interval 1.16 to 1.46
|
1.48 mg/ml
Interval 0.85 to 2.34
|
7.49 mg/ml
Interval 4.31 to 10.51
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day-392)
|
—
|
—
|
—
|
2.73 mg/ml
Interval 1.75 to 5.0
|
|
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
VRC07-523LS (Day-448)
|
—
|
—
|
—
|
1.10 mg/ml
Interval 0.69 to 2.37
|
SECONDARY outcome
Timeframe: Measured during Screening, Days 0, 3, 28, 56, 112, 140*, 168*, 224* Days with * are only available for T4Population: All participants enrolled with available neutralizing antibody data. Visits with 0 participants are due to: (1) Isolates were mAb-specific and only assayed for the treatment arms that received the specific mAbs. (2) Treatment group T4 had more scheduled sample collection visits than treatment groups T1-T3.
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped viruses sensitive to the bnAbs (i.e., bnAb-specific viruses) in each infusion group.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
6540.v4.c1 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
6540.v4.c1 (Day- 3)
|
—
|
—
|
—
|
13187.62 Relative luminescence units (RLU)
Interval 9441.2 to 18617.3
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
6540.v4.c1 (Day- 28)
|
—
|
—
|
—
|
2083.51 Relative luminescence units (RLU)
Interval 1820.8 to 2758.25
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
6540.v4.c1 (Day- 56)
|
—
|
—
|
—
|
774.27 Relative luminescence units (RLU)
Interval 530.97 to 919.39
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
6540.v4.c1 (Day-112)
|
—
|
—
|
—
|
82.11 Relative luminescence units (RLU)
Interval 61.03 to 98.13
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
6540.v4.c1 (Day-140)
|
—
|
—
|
—
|
45.07 Relative luminescence units (RLU)
Interval 25.03 to 650.34
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
6540.v4.c1 (Day-168)
|
—
|
—
|
—
|
14.74 Relative luminescence units (RLU)
Interval 9.87 to 19.62
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
6540.v4.c1 (Day-224)
|
—
|
—
|
—
|
27.66 Relative luminescence units (RLU)
Interval 5.0 to 64.76
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CH505TF.N334S.N160A.N280D.1 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CH505TF.N334S.N160A.N280D.1 (Day- 3)
|
—
|
—
|
—
|
13343.35 Relative luminescence units (RLU)
Interval 9088.55 to 18308.4
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CH505TF.N334S.N160A.N280D.1 (Day- 28)
|
—
|
—
|
—
|
3000.56 Relative luminescence units (RLU)
Interval 2917.48 to 3828.38
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CH505TF.N334S.N160A.N280D.1 (Day- 56)
|
—
|
—
|
—
|
1751.70 Relative luminescence units (RLU)
Interval 1019.21 to 1968.06
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CH505TF.N334S.N160A.N280D.1 (Day-112)
|
—
|
—
|
—
|
339.83 Relative luminescence units (RLU)
Interval 296.59 to 554.03
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CH505TF.N334S.N160A.N280D.1 (Day-140)
|
—
|
—
|
—
|
270.10 Relative luminescence units (RLU)
Interval 176.3 to 1416.59
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CH505TF.N334S.N160A.N280D.1 (Day-168)
|
—
|
—
|
—
|
111.35 Relative luminescence units (RLU)
Interval 86.07 to 136.63
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CH505TF.N334S.N160A.N280D.1 (Day-224)
|
—
|
—
|
—
|
206.62 Relative luminescence units (RLU)
Interval 105.46 to 429.44
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CNE55.N160K (Day- 0)
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CNE55.N160K (Day- 3)
|
917.25 Relative luminescence units (RLU)
Interval 686.59 to 1286.7
|
816.88 Relative luminescence units (RLU)
Interval 725.91 to 847.67
|
438.49 Relative luminescence units (RLU)
Interval 357.53 to 535.46
|
466.43 Relative luminescence units (RLU)
Interval 421.07 to 1000.34
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CNE55.N160K (Day- 28)
|
259.58 Relative luminescence units (RLU)
Interval 212.45 to 323.5
|
188.55 Relative luminescence units (RLU)
Interval 161.5 to 208.8
|
206.12 Relative luminescence units (RLU)
Interval 171.05 to 268.36
|
158.46 Relative luminescence units (RLU)
Interval 146.09 to 233.05
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CNE55.N160K (Day- 56)
|
105.02 Relative luminescence units (RLU)
Interval 91.83 to 118.53
|
91.57 Relative luminescence units (RLU)
Interval 80.4 to 117.12
|
152.21 Relative luminescence units (RLU)
Interval 95.36 to 188.88
|
131.95 Relative luminescence units (RLU)
Interval 98.57 to 134.34
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CNE55.N160K (Day-112)
|
28.65 Relative luminescence units (RLU)
Interval 25.1 to 36.11
|
10.00 Relative luminescence units (RLU)
Interval 10.0 to 20.95
|
47.58 Relative luminescence units (RLU)
Interval 10.0 to 59.38
|
47.57 Relative luminescence units (RLU)
Interval 30.49 to 65.17
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CNE55.N160K (Day-140)
|
—
|
—
|
—
|
18.76 Relative luminescence units (RLU)
Interval 17.13 to 55.76
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CNE55.N160K (Day-168)
|
—
|
—
|
—
|
13.27 Relative luminescence units (RLU)
Interval 9.14 to 17.41
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
CNE55.N160K (Day-224)
|
—
|
—
|
—
|
37.80 Relative luminescence units (RLU)
Interval 14.65 to 58.52
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
T250-4 (Day- 0)
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
—
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
T250-4 (Day- 3)
|
32029.39 Relative luminescence units (RLU)
Interval 28181.95 to 41032.5
|
91301.02 Relative luminescence units (RLU)
Interval 79640.01 to
|
35379.15 Relative luminescence units (RLU)
Interval 25190.07 to 44080.8
|
—
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
T250-4 (Day- 28)
|
6458.16 Relative luminescence units (RLU)
Interval 5518.54 to 7452.56
|
27318.99 Relative luminescence units (RLU)
Interval 23401.71 to 30312.3
|
13028.85 Relative luminescence units (RLU)
Interval 11586.88 to 14345.8
|
—
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
T250-4 (Day- 56)
|
2016.84 Relative luminescence units (RLU)
Interval 1800.34 to 2646.68
|
7523.58 Relative luminescence units (RLU)
Interval 6020.17 to 8716.04
|
6515.27 Relative luminescence units (RLU)
Interval 2851.83 to 7625.68
|
—
|
|
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
T250-4 (Day-112)
|
300.37 Relative luminescence units (RLU)
Interval 266.45 to 650.96
|
800.00 Relative luminescence units (RLU)
Interval 618.17 to 837.77
|
928.27 Relative luminescence units (RLU)
Interval 529.97 to 1449.78
|
—
|
SECONDARY outcome
Timeframe: Measured during Screening, Days 0*, 3, 28, 56*, 112, 140*, 224* Days with * are only available for T4Population: All participants enrolled with available neutralizing antibody data. Visits with 0 participants are due to: Treatment group T4 had more scheduled sample collection visits than treatment groups T1-T3.
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped viruses sensitive to the bnAbs (i.e., bnAb-specific viruses) in each infusion group.
Outcome measures
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 Participants
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 Participants
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 Participants
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 Participants
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
0330.v4.c3 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
0330.v4.c3 (Day- 3)
|
6396.28 Relative luminescence units (RLU)
Interval 6080.23 to 6735.71
|
74297.85 Relative luminescence units (RLU)
Interval 52044.99 to 88109.3
|
6121.19 Relative luminescence units (RLU)
Interval 3340.46 to 12217.9
|
89412.79 Relative luminescence units (RLU)
Interval 81404.07 to
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
0330.v4.c3 (Day- 28)
|
1714.47 Relative luminescence units (RLU)
Interval 1464.17 to 1902.42
|
12264.66 Relative luminescence units (RLU)
Interval 10502.9 to 16471.8
|
1117.61 Relative luminescence units (RLU)
Interval 1052.55 to 1387.42
|
19794.60 Relative luminescence units (RLU)
Interval 12324.14 to 23999.2
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
0330.v4.c3 (Day- 56)
|
—
|
—
|
—
|
5217.82 Relative luminescence units (RLU)
Interval 3172.08 to 6238.47
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
0330.v4.c3 (Day-112)
|
242.94 Relative luminescence units (RLU)
Interval 181.5 to 300.77
|
1216.32 Relative luminescence units (RLU)
Interval 807.32 to 1581.69
|
209.33 Relative luminescence units (RLU)
Interval 99.69 to 222.71
|
611.93 Relative luminescence units (RLU)
Interval 453.02 to 750.19
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
0330.v4.c3 (Day-140)
|
—
|
—
|
—
|
589.67 Relative luminescence units (RLU)
Interval 389.86 to 3617.62
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
0330.v4.c3 (Day-224)
|
—
|
—
|
—
|
343.14 Relative luminescence units (RLU)
Interval 116.53 to 669.99
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
3426.v5.c17 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
3426.v5.c17 (Day- 3)
|
16924.30 Relative luminescence units (RLU)
Interval 14561.42 to 20967.7
|
144218.5 Relative luminescence units (RLU)
Interval 93034.17 to
|
9665.13 Relative luminescence units (RLU)
Interval 7360.48 to 11861.0
|
368712.2 Relative luminescence units (RLU)
Interval 259743.1 to
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
3426.v5.c17 (Day- 28)
|
3041.45 Relative luminescence units (RLU)
Interval 2966.23 to 3290.51
|
32852.84 Relative luminescence units (RLU)
Interval 26522.32 to 46738.8
|
2676.34 Relative luminescence units (RLU)
Interval 2001.12 to 2816.62
|
66390.30 Relative luminescence units (RLU)
Interval 64990.87 to 97262.7
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
3426.v5.c17 (Day- 56)
|
—
|
—
|
—
|
24227.08 Relative luminescence units (RLU)
Interval 8980.36 to 33004.1
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
3426.v5.c17 (Day-112)
|
362.56 Relative luminescence units (RLU)
Interval 274.34 to 473.09
|
1488.31 Relative luminescence units (RLU)
Interval 993.1 to 1671.42
|
447.09 Relative luminescence units (RLU)
Interval 97.17 to 463.62
|
1288.16 Relative luminescence units (RLU)
Interval 1082.09 to 2303.78
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
3426.v5.c17 (Day-140)
|
—
|
—
|
—
|
822.84 Relative luminescence units (RLU)
Interval 540.23 to 14854.5
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
3426.v5.c17 (Day-224)
|
—
|
—
|
—
|
537.48 Relative luminescence units (RLU)
Interval 182.83 to 1909.54
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
377.v4.c09 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
377.v4.c09 (Day- 3)
|
441.18 Relative luminescence units (RLU)
Interval 411.01 to 504.06
|
255.40 Relative luminescence units (RLU)
Interval 209.29 to 281.66
|
380.32 Relative luminescence units (RLU)
Interval 278.05 to 459.21
|
591.58 Relative luminescence units (RLU)
Interval 482.75 to 800.29
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
377.v4.c09 (Day- 28)
|
108.14 Relative luminescence units (RLU)
Interval 102.75 to 114.54
|
63.14 Relative luminescence units (RLU)
Interval 58.58 to 72.02
|
116.45 Relative luminescence units (RLU)
Interval 96.92 to 117.19
|
179.21 Relative luminescence units (RLU)
Interval 127.5 to 211.82
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
377.v4.c09 (Day- 56)
|
—
|
—
|
—
|
85.74 Relative luminescence units (RLU)
Interval 59.71 to 97.87
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
377.v4.c09 (Day-112)
|
16.27 Relative luminescence units (RLU)
Interval 12.25 to 18.09
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
14.68 Relative luminescence units (RLU)
Interval 5.0 to 15.14
|
17.94 Relative luminescence units (RLU)
Interval 13.93 to 26.97
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
377.v4.c09 (Day-140)
|
—
|
—
|
—
|
14.48 Relative luminescence units (RLU)
Interval 9.74 to 91.02
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
377.v4.c09 (Day-224)
|
—
|
—
|
—
|
17.09 Relative luminescence units (RLU)
Interval 5.0 to 37.52
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
AC10.0.29 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
AC10.0.29 (Day- 3)
|
3307.09 Relative luminescence units (RLU)
Interval 3201.01 to 3589.36
|
1198.26 Relative luminescence units (RLU)
Interval 1097.26 to 1305.86
|
2763.45 Relative luminescence units (RLU)
Interval 2425.04 to 3413.11
|
3854.76 Relative luminescence units (RLU)
Interval 3252.76 to 5347.95
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
AC10.0.29 (Day- 28)
|
730.53 Relative luminescence units (RLU)
Interval 710.4 to 751.62
|
285.36 Relative luminescence units (RLU)
Interval 277.39 to 333.6
|
842.99 Relative luminescence units (RLU)
Interval 802.47 to 1038.29
|
1039.01 Relative luminescence units (RLU)
Interval 761.35 to 1117.14
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
AC10.0.29 (Day- 56)
|
—
|
—
|
—
|
500.07 Relative luminescence units (RLU)
Interval 312.83 to 597.44
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
AC10.0.29 (Day-112)
|
58.82 Relative luminescence units (RLU)
Interval 50.35 to 97.12
|
37.55 Relative luminescence units (RLU)
Interval 34.74 to 44.08
|
152.58 Relative luminescence units (RLU)
Interval 28.49 to 154.06
|
85.57 Relative luminescence units (RLU)
Interval 59.92 to 153.51
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
AC10.0.29 (Day-140)
|
—
|
—
|
—
|
75.66 Relative luminescence units (RLU)
Interval 51.59 to 455.2
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
AC10.0.29 (Day-224)
|
—
|
—
|
—
|
57.51 Relative luminescence units (RLU)
Interval 22.44 to 162.14
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
Ce1176_A3 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
Ce1176_A3 (Day- 3)
|
11645.78 Relative luminescence units (RLU)
Interval 9518.45 to 12116.3
|
537.29 Relative luminescence units (RLU)
Interval 459.87 to 586.96
|
4781.11 Relative luminescence units (RLU)
Interval 3229.13 to 7086.33
|
8628.18 Relative luminescence units (RLU)
Interval 6578.27 to 12370.5
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
Ce1176_A3 (Day- 28)
|
1869.57 Relative luminescence units (RLU)
Interval 1853.02 to 2232.85
|
137.78 Relative luminescence units (RLU)
Interval 109.83 to 145.47
|
1475.03 Relative luminescence units (RLU)
Interval 954.07 to 1488.48
|
2081.67 Relative luminescence units (RLU)
Interval 1688.46 to 2313.62
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
Ce1176_A3 (Day- 56)
|
—
|
—
|
—
|
842.00 Relative luminescence units (RLU)
Interval 564.1 to 1444.53
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
Ce1176_A3 (Day-112)
|
139.63 Relative luminescence units (RLU)
Interval 95.9 to 265.94
|
28.13 Relative luminescence units (RLU)
Interval 17.77 to 28.27
|
165.45 Relative luminescence units (RLU)
Interval 41.81 to 206.47
|
199.63 Relative luminescence units (RLU)
Interval 160.77 to 372.51
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
Ce1176_A3 (Day-140)
|
—
|
—
|
—
|
205.80 Relative luminescence units (RLU)
Interval 128.04 to 963.06
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
Ce1176_A3 (Day-224)
|
—
|
—
|
—
|
101.07 Relative luminescence units (RLU)
Interval 48.45 to 381.19
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU156.12 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU156.12 (Day- 3)
|
18539.26 Relative luminescence units (RLU)
Interval 17172.56 to 23579.6
|
27452.85 Relative luminescence units (RLU)
Interval 26185.95 to 28715.5
|
10841.11 Relative luminescence units (RLU)
Interval 5764.85 to 14232.2
|
84807.92 Relative luminescence units (RLU)
Interval 32946.35 to
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU156.12 (Day- 28)
|
4812.81 Relative luminescence units (RLU)
Interval 4150.62 to 5672.03
|
6655.88 Relative luminescence units (RLU)
Interval 5796.38 to 6937.67
|
2989.42 Relative luminescence units (RLU)
Interval 2466.94 to 3703.45
|
14630.79 Relative luminescence units (RLU)
Interval 12167.11 to 23357.8
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU156.12 (Day- 56)
|
—
|
—
|
—
|
3915.57 Relative luminescence units (RLU)
Interval 2878.16 to 5887.1
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU156.12 (Day-112)
|
632.13 Relative luminescence units (RLU)
Interval 498.04 to 735.92
|
620.22 Relative luminescence units (RLU)
Interval 503.29 to 741.76
|
629.27 Relative luminescence units (RLU)
Interval 199.42 to 648.1
|
744.96 Relative luminescence units (RLU)
Interval 605.25 to 1202.94
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU156.12 (Day-140)
|
—
|
—
|
—
|
627.31 Relative luminescence units (RLU)
Interval 437.57 to 4019.46
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU156.12 (Day-224)
|
—
|
—
|
—
|
578.62 Relative luminescence units (RLU)
Interval 161.72 to 832.75
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU172.17 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU172.17 (Day- 3)
|
1518.88 Relative luminescence units (RLU)
Interval 1163.34 to 1850.98
|
448.77 Relative luminescence units (RLU)
Interval 342.15 to 495.87
|
1315.85 Relative luminescence units (RLU)
Interval 1037.49 to 1898.68
|
1631.83 Relative luminescence units (RLU)
Interval 1393.41 to 1944.91
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU172.17 (Day- 28)
|
434.85 Relative luminescence units (RLU)
Interval 402.56 to 448.27
|
170.68 Relative luminescence units (RLU)
Interval 119.08 to 194.91
|
398.72 Relative luminescence units (RLU)
Interval 383.47 to 448.6
|
413.93 Relative luminescence units (RLU)
Interval 332.95 to 532.05
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU172.17 (Day- 56)
|
—
|
—
|
—
|
187.19 Relative luminescence units (RLU)
Interval 162.9 to 224.12
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU172.17 (Day-112)
|
45.10 Relative luminescence units (RLU)
Interval 37.03 to 71.39
|
16.67 Relative luminescence units (RLU)
Interval 5.0 to 22.47
|
61.30 Relative luminescence units (RLU)
Interval 16.72 to 66.06
|
56.99 Relative luminescence units (RLU)
Interval 46.08 to 78.16
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU172.17 (Day-140)
|
—
|
—
|
—
|
43.33 Relative luminescence units (RLU)
Interval 27.32 to 178.56
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
DU172.17 (Day-224)
|
—
|
—
|
—
|
33.71 Relative luminescence units (RLU)
Interval 11.22 to 72.76
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
PVO.4 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
PVO.4 (Day- 3)
|
1834.12 Relative luminescence units (RLU)
Interval 1630.5 to 2102.57
|
773.42 Relative luminescence units (RLU)
Interval 697.14 to 903.36
|
1918.35 Relative luminescence units (RLU)
Interval 1098.33 to 2093.31
|
2078.34 Relative luminescence units (RLU)
Interval 1885.71 to 2315.32
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
PVO.4 (Day- 28)
|
523.42 Relative luminescence units (RLU)
Interval 443.0 to 527.84
|
244.89 Relative luminescence units (RLU)
Interval 240.35 to 248.11
|
548.04 Relative luminescence units (RLU)
Interval 529.82 to 634.73
|
611.64 Relative luminescence units (RLU)
Interval 557.45 to 649.11
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
PVO.4 (Day- 56)
|
—
|
—
|
—
|
316.00 Relative luminescence units (RLU)
Interval 215.71 to 363.56
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
PVO.4 (Day-112)
|
80.37 Relative luminescence units (RLU)
Interval 67.76 to 93.09
|
50.58 Relative luminescence units (RLU)
Interval 46.64 to 54.4
|
99.15 Relative luminescence units (RLU)
Interval 40.87 to 104.77
|
92.98 Relative luminescence units (RLU)
Interval 76.81 to 112.41
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
PVO.4 (Day-140)
|
—
|
—
|
—
|
45.61 Relative luminescence units (RLU)
Interval 40.7 to 230.18
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
PVO.4 (Day-224)
|
—
|
—
|
—
|
58.33 Relative luminescence units (RLU)
Interval 20.52 to 110.43
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
RHPA4259.7 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
RHPA4259.7 (Day- 3)
|
15786.94 Relative luminescence units (RLU)
Interval 13562.87 to 19915.2
|
4313.94 Relative luminescence units (RLU)
Interval 3709.44 to 5821.77
|
6847.08 Relative luminescence units (RLU)
Interval 5023.53 to 9267.51
|
11323.55 Relative luminescence units (RLU)
Interval 10578.46 to 15367.3
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
RHPA4259.7 (Day- 28)
|
3718.80 Relative luminescence units (RLU)
Interval 3383.58 to 4228.2
|
1748.53 Relative luminescence units (RLU)
Interval 1639.88 to 1788.12
|
2996.20 Relative luminescence units (RLU)
Interval 2164.6 to 3266.73
|
3560.23 Relative luminescence units (RLU)
Interval 3338.05 to 3839.56
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
RHPA4259.7 (Day- 56)
|
—
|
—
|
—
|
2114.58 Relative luminescence units (RLU)
Interval 1601.57 to 2685.28
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
RHPA4259.7 (Day-112)
|
663.30 Relative luminescence units (RLU)
Interval 477.36 to 857.77
|
506.64 Relative luminescence units (RLU)
Interval 364.1 to 511.53
|
528.88 Relative luminescence units (RLU)
Interval 267.5 to 555.36
|
562.77 Relative luminescence units (RLU)
Interval 485.83 to 788.27
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
RHPA4259.7 (Day-140)
|
—
|
—
|
—
|
384.75 Relative luminescence units (RLU)
Interval 279.01 to 1524.8
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
RHPA4259.7 (Day-224)
|
—
|
—
|
—
|
406.26 Relative luminescence units (RLU)
Interval 131.41 to 768.36
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
SC422661.8 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
SC422661.8 (Day- 3)
|
3925.17 Relative luminescence units (RLU)
Interval 3766.76 to 4704.83
|
2519.42 Relative luminescence units (RLU)
Interval 1997.2 to 2761.47
|
3601.22 Relative luminescence units (RLU)
Interval 2513.76 to 4602.54
|
5345.96 Relative luminescence units (RLU)
Interval 3397.0 to 5947.47
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
SC422661.8 (Day- 28)
|
1389.90 Relative luminescence units (RLU)
Interval 1302.5 to 1530.08
|
1035.29 Relative luminescence units (RLU)
Interval 725.16 to 1287.34
|
1408.81 Relative luminescence units (RLU)
Interval 1227.23 to 1411.6
|
1377.52 Relative luminescence units (RLU)
Interval 1147.39 to 1725.51
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
SC422661.8 (Day- 56)
|
—
|
—
|
—
|
765.08 Relative luminescence units (RLU)
Interval 625.41 to 991.03
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
SC422661.8 (Day-112)
|
213.39 Relative luminescence units (RLU)
Interval 186.07 to 275.41
|
163.39 Relative luminescence units (RLU)
Interval 156.87 to 174.58
|
219.98 Relative luminescence units (RLU)
Interval 95.53 to 267.65
|
189.00 Relative luminescence units (RLU)
Interval 183.79 to 276.06
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
SC422661.8 (Day-140)
|
—
|
—
|
—
|
120.06 Relative luminescence units (RLU)
Interval 103.68 to 514.08
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
SC422661.8 (Day-224)
|
—
|
—
|
—
|
192.58 Relative luminescence units (RLU)
Interval 53.76 to 269.09
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
T263-8 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
T263-8 (Day- 3)
|
2776.59 Relative luminescence units (RLU)
Interval 2281.26 to 3281.31
|
8794.97 Relative luminescence units (RLU)
Interval 8451.76 to 11791.8
|
1811.12 Relative luminescence units (RLU)
Interval 1236.81 to 1988.47
|
10506.56 Relative luminescence units (RLU)
Interval 7759.25 to 12494.5
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
T263-8 (Day- 28)
|
652.72 Relative luminescence units (RLU)
Interval 623.52 to 799.07
|
2180.36 Relative luminescence units (RLU)
Interval 2077.13 to 2332.7
|
709.37 Relative luminescence units (RLU)
Interval 659.45 to 713.01
|
2076.06 Relative luminescence units (RLU)
Interval 2000.37 to 2452.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
T263-8 (Day- 56)
|
—
|
—
|
—
|
789.69 Relative luminescence units (RLU)
Interval 562.19 to 1124.91
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
T263-8 (Day-112)
|
168.55 Relative luminescence units (RLU)
Interval 139.98 to 176.97
|
260.69 Relative luminescence units (RLU)
Interval 204.99 to 326.59
|
156.80 Relative luminescence units (RLU)
Interval 77.23 to 174.38
|
169.57 Relative luminescence units (RLU)
Interval 128.05 to 260.28
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
T263-8 (Day-140)
|
—
|
—
|
—
|
99.18 Relative luminescence units (RLU)
Interval 83.78 to 680.21
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
T263-8 (Day-224)
|
—
|
—
|
—
|
130.83 Relative luminescence units (RLU)
Interval 36.33 to 281.58
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
TRO.11 (Day- 0)
|
—
|
—
|
—
|
5.00 Relative luminescence units (RLU)
Interval 5.0 to 5.0
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
TRO.11 (Day- 3)
|
7813.45 Relative luminescence units (RLU)
Interval 7044.18 to 8400.16
|
887.77 Relative luminescence units (RLU)
Interval 744.43 to 1025.75
|
4253.82 Relative luminescence units (RLU)
Interval 2683.78 to 5150.14
|
8880.74 Relative luminescence units (RLU)
Interval 6305.55 to 9378.98
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
TRO.11 (Day- 28)
|
1503.04 Relative luminescence units (RLU)
Interval 1409.62 to 1726.44
|
249.19 Relative luminescence units (RLU)
Interval 202.44 to 318.67
|
1085.04 Relative luminescence units (RLU)
Interval 954.52 to 1375.31
|
1963.86 Relative luminescence units (RLU)
Interval 1656.59 to 2787.73
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
TRO.11 (Day- 56)
|
—
|
—
|
—
|
1023.42 Relative luminescence units (RLU)
Interval 611.4 to 1196.5
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
TRO.11 (Day-112)
|
116.90 Relative luminescence units (RLU)
Interval 101.82 to 156.21
|
73.93 Relative luminescence units (RLU)
Interval 37.19 to 75.09
|
193.46 Relative luminescence units (RLU)
Interval 66.49 to 206.92
|
182.49 Relative luminescence units (RLU)
Interval 153.74 to 287.64
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
TRO.11 (Day-140)
|
—
|
—
|
—
|
146.55 Relative luminescence units (RLU)
Interval 95.84 to 783.56
|
|
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
TRO.11 (Day-224)
|
—
|
—
|
—
|
111.00 Relative luminescence units (RLU)
Interval 47.82 to 333.09
|
Adverse Events
T1: PGT121 + VRC07-523LS mo 0
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
T2: PGDM1400 + VRC07-523LS mo 0
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
T3: 10-1074 + VRC07-523LS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 participants at risk
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 participants at risk
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 participants at risk
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 participants at risk
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
Other adverse events
| Measure |
T1: PGT121 + VRC07-523LS mo 0
n=6 participants at risk
PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T2: PGDM1400 + VRC07-523LS mo 0
n=6 participants at risk
PGDM1400 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T3: 10-1074 + VRC07-523LS
n=6 participants at risk
10-1074 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0.
|
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
n=9 participants at risk
PGDM1400 20 mg/kg AND PGT121 20 mg/kg AND VRC07-523LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Any Event in SOC
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
General disorders
Any Event in SOC
|
33.3%
2/6 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
General disorders
Fatigue
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
General disorders
Influenza like illness
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
General disorders
Infusion site extravasation
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Infections and infestations
Any Event in SOC
|
50.0%
3/6 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
33.3%
2/6 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
33.3%
3/9 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Infections and infestations
Latent tuberculosis
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Infections and infestations
Pharyngeal chlamydia infection
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
33.3%
2/6 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
33.3%
2/6 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Investigations
Any Event in SOC
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
33.3%
2/6 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
22.2%
2/9 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Nervous system disorders
Any Event in SOC
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Psychiatric disorders
Any Event in SOC
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Renal and urinary disorders
Any Event in SOC
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
33.3%
2/6 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Skin and subcutaneous tissue disorders
Androgenetic alopecia
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
11.1%
1/9 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
0.00%
0/9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place