Trial Outcomes & Findings for Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult Participants (NCT NCT03735849)
NCT ID: NCT03735849
Last Updated: 2025-06-05
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected 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
28 participants
Primary outcome timeframe
Measured through 3 days after each infusion at weeks 0, 16 and 32
Results posted on
2025-06-05
Participant Flow
Participant milestones
| Measure |
Group 1: Vaccine
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 3: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
4
|
|
Overall Study
Safety Population
|
11
|
13
|
4
|
|
Overall Study
COMPLETED
|
9
|
13
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
4
|
Reasons for withdrawal
| Measure |
Group 1: Vaccine
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 3: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Participant unable to adhere to visit
|
1
|
0
|
0
|
|
Overall Study
Not Randomized
|
0
|
0
|
4
|
Baseline Characteristics
Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult Participants
Baseline characteristics by cohort
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 3: Pre-treatment
n=4 Participants
Biopsy collected but was not randomized to any treatment group
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28 years
n=39 Participants
|
26 years
n=41 Participants
|
22 years
n=35 Participants
|
26 years
n=31 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Customized
18 - 20 years
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Age, Customized
21 - 30 years
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
|
Age, Customized
31 - 40 years
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Age, Customized
41 - 50 years
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
25 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
21 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
USA
|
11 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
28 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each infusion at weeks 0, 16 and 32Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Mild
|
6 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · None
|
10 Participants
|
11 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Mild
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · None
|
5 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema · None
|
10 Participants
|
12 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema · Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration · None
|
11 Participants
|
12 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration · Mild
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each infusion at weeks 0, 16 and 32Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
3 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
6 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
8 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
3 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
3 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
6 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
9 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
10 Participants
|
11 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · None
|
8 Participants
|
12 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Mild
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · None
|
11 Participants
|
12 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Mild
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · None
|
11 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · None
|
10 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · None
|
11 Participants
|
12 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · None
|
10 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
5 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
10 Participants
|
11 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured during screening, visit 4(day 14), 6 (day 126) and 8 (day 238)Population: Samples were missing for follow-up visits due to miss visits or discontinuing study product.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)- Screening
|
19.0 U/L
Interval 9.0 to 26.0
|
16.0 U/L
Interval 11.0 to 20.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)-Day 14
|
14.0 U/L
Interval 10.0 to 18.0
|
16.0 U/L
Interval 12.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)-Day 126
|
22.0 U/L
Interval 13.0 to 24.0
|
17.0 U/L
Interval 12.0 to 26.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)-Day 238
|
16.0 U/L
Interval 14.0 to 26.0
|
14.0 U/L
Interval 11.0 to 23.0
|
PRIMARY outcome
Timeframe: Measured during screening, Day 14, 126, 238Population: Samples were missing for follow-up visits due to miss visits or discontinuing study product.
For each local laboratory measure-Hemoglobin and Creatinine (g/dl), summary statistics were presented by treatment group and time point for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl)
Creatinine (g/dL)-Day 14
|
.00082 g/dL
Interval 0.00071 to 0.00091
|
.00081 g/dL
Interval 0.00076 to 0.00092
|
|
Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl)
Hemoglobin (g/dL)- Screening
|
14.3 g/dL
Interval 13.3 to 14.6
|
13.9 g/dL
Interval 12.9 to 15.0
|
|
Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl)
Hemoglobin (g/dL)-Day 14
|
13.4 g/dL
Interval 13.2 to 14.9
|
13.2 g/dL
Interval 12.3 to 14.8
|
|
Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl)
Hemoglobin (g/dL)-Day 126
|
13.9 g/dL
Interval 13.4 to 14.7
|
14.0 g/dL
Interval 12.4 to 15.0
|
|
Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl)
Hemoglobin (g/dL)-Day 238
|
13.9 g/dL
Interval 13.6 to 14.3
|
13.2 g/dL
Interval 12.6 to 14.8
|
|
Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl)
Creatinine (g/dL)- Screening
|
.00076 g/dL
Interval 0.00071 to 0.00094
|
.00078 g/dL
Interval 0.00071 to 0.00093
|
|
Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl)
Creatinine (g/dL)-Day 126
|
.00077 g/dL
Interval 0.0007 to 0.00102
|
.00081 g/dL
Interval 0.00064 to 0.00095
|
|
Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl)
Creatinine (g/dL)-Day 238
|
.00070 g/dL
Interval 0.00067 to 0.00084
|
.00085 g/dL
Interval 0.00067 to 0.00093
|
PRIMARY outcome
Timeframe: Measured during screening, Day 14, 126, 238Population: Samples were missing for follow-up visits due to miss visits or discontinuing study product.
For each local laboratory measure lymphocyte count, neutrophil count, platelets, white blood cells (WBC) in 1000/ cubic mm summary statistics were presented by treatment group and time point
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Screening
|
8.03 1000 cells/cubic mm
Interval 5.91 to 8.77
|
7.12 1000 cells/cubic mm
Interval 5.43 to 7.41
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)-Day 14
|
6.22 1000 cells/cubic mm
Interval 5.18 to 8.77
|
7.12 1000 cells/cubic mm
Interval 5.65 to 7.5
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)-Day 126
|
7.63 1000 cells/cubic mm
Interval 6.35 to 8.46
|
5.55 1000 cells/cubic mm
Interval 5.35 to 6.21
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)-Day 238
|
8.02 1000 cells/cubic mm
Interval 6.88 to 8.42
|
5.22 1000 cells/cubic mm
Interval 4.54 to 5.94
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000 cells/cubic mm)- Screening
|
4.74 1000 cells/cubic mm
Interval 3.11 to 5.53
|
3.45 1000 cells/cubic mm
Interval 3.0 to 4.89
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000 cells/cubic mm)-Day 14
|
3.65 1000 cells/cubic mm
Interval 3.25 to 5.85
|
3.90 1000 cells/cubic mm
Interval 3.17 to 4.82
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000 cells/cubic mm)-Day 126
|
4.98 1000 cells/cubic mm
Interval 4.2 to 5.45
|
3.19 1000 cells/cubic mm
Interval 2.99 to 3.72
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000 cells/cubic mm)-Day 238
|
4.75 1000 cells/cubic mm
Interval 3.92 to 6.29
|
3.10 1000 cells/cubic mm
Interval 1.99 to 3.43
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000 cells/cubic mm)- Screening
|
2.30 1000 cells/cubic mm
Interval 1.39 to 2.45
|
2.28 1000 cells/cubic mm
Interval 1.63 to 2.67
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000 cells/cubic mm)-Day 14
|
1.91 1000 cells/cubic mm
Interval 1.2 to 2.51
|
1.82 1000 cells/cubic mm
Interval 1.73 to 2.31
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000 cells/cubic mm)-Day 126
|
1.72 1000 cells/cubic mm
Interval 1.41 to 2.37
|
1.71 1000 cells/cubic mm
Interval 1.18 to 2.19
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000 cells/cubic mm)-Day 238
|
2.04 1000 cells/cubic mm
Interval 1.5 to 2.27
|
1.64 1000 cells/cubic mm
Interval 1.14 to 2.02
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Screening
|
260 1000 cells/cubic mm
Interval 224.0 to 293.0
|
249 1000 cells/cubic mm
Interval 215.0 to 273.0
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)-Day 14
|
243 1000 cells/cubic mm
Interval 215.0 to 291.0
|
225 1000 cells/cubic mm
Interval 213.0 to 279.0
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)-Day 126
|
247 1000 cells/cubic mm
Interval 226.0 to 263.0
|
253 1000 cells/cubic mm
Interval 221.0 to 280.0
|
|
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)-Day 238
|
239 1000 cells/cubic mm
Interval 230.0 to 271.0
|
264 1000 cells/cubic mm
Interval 206.0 to 300.0
|
PRIMARY outcome
Timeframe: Measured during screening, Day 14, 126, 238Population: Samples were missing for follow-up visits due to miss visits or discontinuing study product.
Counts of lab grade \>1 for ALT, creatine, hemoglobin, lymphocyte count, neutrophil, platelets, white blood cells
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Chemistry and Hematology Laboratory Measures
WBC (1000 cells/cubic mm)- Screening
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
WBC (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
WBC (1000 cells/cubic mm)-Day 126
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
WBC (1000 cells/cubic mm)-Day 238
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells/cubic mm)- Screening
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells/cubic mm)-Day 126
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells/cubic mm)-Day 238
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Hemoglobin (g/dL)- Screening
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Hemoglobin (g/dL)-Day 14
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Hemoglobin (g/dL)-Day 126
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Hemoglobin (g/dL)-Day 238
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells/cubic mm)- Screening
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells/cubic mm)-Day 126
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells/cubic mm)-Day 238
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Platelets (1000 cells/cubic mm)- Screening
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Platelets (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Platelets (1000 cells/cubic mm)-Day 126
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Platelets (1000 cells/cubic mm)-Day 238
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)- Screening
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)-Day 14
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)-Day 126
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)-Day 238
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Creatinine (g/dL)- Screening
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Creatinine (g/dL)-Day 14
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Creatinine (g/dL)-Day 126
|
1 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures
Creatinine (g/dL)-Day 238
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Enrollment through week 48Participants Max severity reported per participant over visit.
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs)
No AE reported
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
Mild
|
1 Participants
|
4 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
Moderate
|
9 Participants
|
6 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
Potentially life-threatening
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Enrollment through last scheduled dose at week 32The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Clinical event (not reacto, HIV, death)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Subject unable to attend clinic visits
|
1 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Did not discontinue SPA
|
10 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal).Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the concentration of VRC07-523LS.
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 4
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 6
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 8
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 4
|
214747.1 µg/mL
Interval 199223.5 to 227049.4
|
329345.7 µg/mL
Interval 249175.5 to 625128.3
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 5
|
34446.39 µg/mL
Interval 30663.42 to 55936.2
|
81633.99 µg/mL
Interval 55119.07 to 123155.9
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 9
|
531608.8 µg/mL
Interval 280123.4 to 783094.2
|
176998.6 µg/mL
Interval 153141.8 to 597229.0
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 7
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 2
|
461.26 µg/mL
Interval 461.26 to 461.26
|
461.26 µg/mL
Interval 461.26 to 461.26
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 8
|
182851.1 µg/mL
Interval 151294.8 to 235197.4
|
715593.4 µg/mL
Interval 470775.6 to 736740.7
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 4
|
70184.27 µg/mL
Interval 35745.15 to 126879.8
|
178305 µg/mL
Interval 121589.3 to 401886.0
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 8
|
57049.38 µg/mL
Interval 46153.7 to 166880.5
|
175382.4 µg/mL
Interval 102097.3 to 322539.0
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 9
|
32941.43 µg/mL
Interval 1153.16 to 45682.22
|
53680.14 µg/mL
Interval 22712.45 to 83060.03
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 2
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 9
|
18611.77 µg/mL
Interval 1153.16 to 36971.61
|
80218.02 µg/mL
Interval 64065.28 to 94174.95
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 9
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 5
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 4
|
202976.8 µg/mL
Interval 177021.1 to 210773.2
|
568748 µg/mL
Interval 543576.9 to 623879.0
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 6
|
317137.1 µg/mL
Interval 269689.4 to 365345.4
|
579910.8 µg/mL
Interval 519728.2 to 660392.1
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 7
|
48960.51 µg/mL
Interval 37631.99 to 60626.1
|
70942.9 µg/mL
Interval 48683.17 to 99838.85
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 8
|
265248.3 µg/mL
Interval 205725.2 to 291173.4
|
518469.9 µg/mL
Interval 344545.0 to 610333.2
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 9
|
60255.85 µg/mL
Interval 47412.77 to 79063.26
|
87682.25 µg/mL
Interval 38238.46 to 185159.1
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 2
|
1153.16 µg/mL
Interval 1153.16 to 26506.86
|
1153.16 µg/mL
Interval 1153.16 to 38269.62
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 4
|
1310855 µg/mL
Interval 861547.6 to 2562996.0
|
5006078 µg/mL
Interval 2617554.0 to 44842195.0
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 5
|
201939.7 µg/mL
Interval 187546.5 to 244570.1
|
436561.2 µg/mL
Interval 352180.6 to 518304.3
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 2
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 2
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 4
|
134874.1 µg/mL
Interval 42174.8 to 219166.6
|
219156.5 µg/mL
Interval 168027.4 to 430497.1
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 8
|
284185.5 µg/mL
Interval 195676.0 to 319445.8
|
641581.4 µg/mL
Interval 556010.9 to 683383.9
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 6
|
4357902 µg/mL
Interval 3453944.0 to 5201059.0
|
2999531 µg/mL
Interval 2534151.0 to 7238536.0
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 7
|
1025192 µg/mL
Interval 751975.2 to 1102886.0
|
649319.1 µg/mL
Interval 279858.1 to 5294497.0
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 8
|
2861361 µg/mL
Interval 2774501.0 to 5461087.0
|
2640954 µg/mL
Interval 2132056.0 to 3999627.0
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 2
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 4
|
130086.2 µg/mL
Interval 81265.22 to 147405.1
|
247847.2 µg/mL
Interval 184451.4 to 363720.2
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 8
|
105012 µg/mL
Interval 52614.97 to 146829.3
|
111503.2 µg/mL
Interval 1153.16 to 130445.6
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 9
|
30650.35 µg/mL
Interval 1153.16 to 44028.03
|
24562.42 µg/mL
Interval 1153.16 to 48930.89
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 9
|
34940.14 µg/mL
Interval 20126.11 to 43457.49
|
56888.7 µg/mL
Interval 36844.67 to 95985.49
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 2
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 4
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 5
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 6
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 7
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 8
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 9
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
|
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 2
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
1153.16 µg/mL
Interval 1153.16 to 1153.16
|
PRIMARY outcome
Timeframe: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal).Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the IgG-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total IgG (ng/mL).
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 2
|
0.085 pg mAb/ng total IgG
Interval 0.075 to 0.11
|
0.09 pg mAb/ng total IgG
Interval 0.071 to 0.095
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 9
|
1.02 pg mAb/ng total IgG
Interval 0.13 to 2.22
|
5.46 pg mAb/ng total IgG
Interval 5.19 to 5.78
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 4
|
8.35 pg mAb/ng total IgG
Interval 7.33 to 10.18
|
23.4 pg mAb/ng total IgG
Interval 18.91 to 27.21
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 8
|
16.05 pg mAb/ng total IgG
Interval 13.81 to 16.45
|
41.92 pg mAb/ng total IgG
Interval 35.04 to 45.7
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 2
|
1.1 pg mAb/ng total IgG
Interval 0.93 to 1.76
|
4.39 pg mAb/ng total IgG
Interval 0.91 to 10.43
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 2
|
0.062 pg mAb/ng total IgG
Interval 0.039 to 0.1
|
0.047 pg mAb/ng total IgG
Interval 0.021 to 0.08
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 4
|
3.92 pg mAb/ng total IgG
Interval 2.81 to 4.46
|
8.28 pg mAb/ng total IgG
Interval 7.56 to 10.33
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 8
|
5.52 pg mAb/ng total IgG
Interval 4.62 to 6.29
|
11.56 pg mAb/ng total IgG
Interval 7.8 to 13.53
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 9
|
0.84 pg mAb/ng total IgG
Interval 0.56 to 1.2
|
2.18 pg mAb/ng total IgG
Interval 1.58 to 2.42
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 4
|
9.8 pg mAb/ng total IgG
Interval 7.95 to 12.25
|
37.18 pg mAb/ng total IgG
Interval 30.12 to 41.68
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 8
|
12.41 pg mAb/ng total IgG
Interval 10.2 to 13.97
|
44.02 pg mAb/ng total IgG
Interval 34.79 to 47.84
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 2
|
0.05 pg mAb/ng total IgG
Interval 0.048 to 0.057
|
0.07 pg mAb/ng total IgG
Interval 0.056 to 0.082
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 9
|
2.34 pg mAb/ng total IgG
Interval 1.74 to 2.4
|
4.22 pg mAb/ng total IgG
Interval 1.54 to 7.49
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 4
|
0.96 pg mAb/ng total IgG
Interval 0.75 to 1.86
|
7.05 pg mAb/ng total IgG
Interval 2.24 to 11.44
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 5
|
2.26 pg mAb/ng total IgG
Interval 1.6 to 7.7
|
3.22 pg mAb/ng total IgG
Interval 2.46 to 7.5
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 6
|
1.43 pg mAb/ng total IgG
Interval 1.3 to 1.51
|
4.08 pg mAb/ng total IgG
Interval 1.87 to 6.09
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 7
|
2.22 pg mAb/ng total IgG
Interval 1.44 to 6.83
|
2.77 pg mAb/ng total IgG
Interval 1.79 to 5.48
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 8
|
2.79 pg mAb/ng total IgG
Interval 2.23 to 3.44
|
2.01 pg mAb/ng total IgG
Interval 1.62 to 4.23
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 9
|
1.89 pg mAb/ng total IgG
Interval 1.19 to 2.65
|
1.51 pg mAb/ng total IgG
Interval 0.99 to 4.09
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 2
|
1.86 pg mAb/ng total IgG
Interval 1.41 to 2.84
|
0.66 pg mAb/ng total IgG
Interval 0.35 to 0.72
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 4
|
4.29 pg mAb/ng total IgG
Interval 3.0 to 5.15
|
0.92 pg mAb/ng total IgG
Interval 0.72 to 1.28
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 5
|
4.43 pg mAb/ng total IgG
Interval 3.77 to 6.17
|
1.07 pg mAb/ng total IgG
Interval 0.85 to 2.88
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 6
|
3.62 pg mAb/ng total IgG
Interval 2.45 to 4.79
|
2.38 pg mAb/ng total IgG
Interval 1.92 to 3.23
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 7
|
5.8 pg mAb/ng total IgG
Interval 3.04 to 8.14
|
0.63 pg mAb/ng total IgG
Interval 0.43 to 1.86
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 8
|
0.6 pg mAb/ng total IgG
Interval 0.6 to 0.6
|
2.56 pg mAb/ng total IgG
Interval 1.78 to 3.35
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 9
|
2.18 pg mAb/ng total IgG
Interval 2.12 to 2.25
|
2.58 pg mAb/ng total IgG
Interval 0.89 to 3.78
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 2
|
0.022 pg mAb/ng total IgG
Interval 0.017 to 0.027
|
0.03 pg mAb/ng total IgG
Interval 0.025 to 0.039
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 4
|
9.08 pg mAb/ng total IgG
Interval 5.24 to 10.88
|
27.43 pg mAb/ng total IgG
Interval 14.99 to 28.27
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 5
|
1.62 pg mAb/ng total IgG
Interval 1.53 to 2.34
|
3.57 pg mAb/ng total IgG
Interval 2.73 to 4.97
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 6
|
16.09 pg mAb/ng total IgG
Interval 11.75 to 19.11
|
26.85 pg mAb/ng total IgG
Interval 22.29 to 33.2
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 7
|
2.44 pg mAb/ng total IgG
Interval 1.86 to 3.42
|
2.71 pg mAb/ng total IgG
Interval 2.09 to 5.7
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 8
|
14.07 pg mAb/ng total IgG
Interval 11.04 to 15.81
|
28.18 pg mAb/ng total IgG
Interval 25.16 to 33.77
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 9
|
2.76 pg mAb/ng total IgG
Interval 2.26 to 3.23
|
2.95 pg mAb/ng total IgG
Interval 1.74 to 6.46
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 2
|
0.0068 pg mAb/ng total IgG
Interval 0.0054 to 0.028
|
0.009 pg mAb/ng total IgG
Interval 0.0018 to 0.079
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 4
|
3.74 pg mAb/ng total IgG
Interval 2.77 to 6.82
|
14.74 pg mAb/ng total IgG
Interval 12.99 to 21.47
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 5
|
0.71 pg mAb/ng total IgG
Interval 0.67 to 0.75
|
2.75 pg mAb/ng total IgG
Interval 1.83 to 2.81
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 6
|
6.8 pg mAb/ng total IgG
Interval 6.41 to 9.1
|
15.66 pg mAb/ng total IgG
Interval 11.02 to 18.49
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 7
|
1.6 pg mAb/ng total IgG
Interval 0.88 to 2.65
|
1.73 pg mAb/ng total IgG
Interval 0.81 to 4.34
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 8
|
7.15 pg mAb/ng total IgG
Interval 4.64 to 8.69
|
18.05 pg mAb/ng total IgG
Interval 12.38 to 20.9
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 9
|
0.88 pg mAb/ng total IgG
Interval 0.54 to 1.21
|
1.38 pg mAb/ng total IgG
Interval 1.0 to 2.18
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 2
|
0.059 pg mAb/ng total IgG
Interval 0.044 to 0.098
|
0.23 pg mAb/ng total IgG
Interval 0.073 to 0.48
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 4
|
4.85 pg mAb/ng total IgG
Interval 4.61 to 5.67
|
14.49 pg mAb/ng total IgG
Interval 11.25 to 14.66
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 8
|
7.41 pg mAb/ng total IgG
Interval 5.85 to 8.53
|
11.41 pg mAb/ng total IgG
Interval 0.83 to 16.54
|
|
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 9
|
1.29 pg mAb/ng total IgG
Interval 0.33 to 1.49
|
3.01 pg mAb/ng total IgG
Interval 2.53 to 4.81
|
PRIMARY outcome
Timeframe: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal).Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the protein-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total protein (ng/mL).
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 8
|
0.21 pg mAb/ng total protein
Interval 0.17 to 0.22
|
0.6 pg mAb/ng total protein
Interval 0.54 to 0.61
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 9
|
0.027 pg mAb/ng total protein
Interval 0.016 to 0.034
|
0.047 pg mAb/ng total protein
Interval 0.03 to 0.078
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 7
|
0.0035 pg mAb/ng total protein
Interval 0.0031 to 0.004
|
0.0038 pg mAb/ng total protein
Interval 0.003 to 0.0046
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 8
|
0.004 pg mAb/ng total protein
Interval 0.003 to 0.0043
|
0.0043 pg mAb/ng total protein
Interval 0.0039 to 0.0048
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 6
|
0.025 pg mAb/ng total protein
Interval 0.024 to 0.026
|
0.058 pg mAb/ng total protein
Interval 0.044 to 0.076
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 2
|
0.00043 pg mAb/ng total protein
Interval 0.00033 to 0.0014
|
0.00025 pg mAb/ng total protein
Interval 0.000067 to 0.0038
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 4
|
0.16 pg mAb/ng total protein
Interval 0.041 to 0.4
|
0.32 pg mAb/ng total protein
Interval 0.21 to 1.58
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 4
|
0.14 pg mAb/ng total protein
Interval 0.1 to 0.18
|
0.34 pg mAb/ng total protein
Interval 0.22 to 0.47
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 5
|
0.017 pg mAb/ng total protein
Interval 0.01 to 0.036
|
0.051 pg mAb/ng total protein
Interval 0.038 to 0.083
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 6
|
0.22 pg mAb/ng total protein
Interval 0.18 to 0.25
|
0.36 pg mAb/ng total protein
Interval 0.21 to 0.46
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 2
|
0.0024 pg mAb/ng total protein
Interval 0.0018 to 0.0033
|
0.0018 pg mAb/ng total protein
Interval 0.001 to 0.0029
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 4
|
0.12 pg mAb/ng total protein
Interval 0.086 to 0.18
|
0.32 pg mAb/ng total protein
Interval 0.27 to 0.49
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 8
|
0.16 pg mAb/ng total protein
Interval 0.12 to 0.24
|
0.36 pg mAb/ng total protein
Interval 0.3 to 0.5
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Cervical Biopsy-Female-Visit 9
|
0.054 pg mAb/ng total protein
Interval 0.0051 to 0.056
|
0.086 pg mAb/ng total protein
Interval 0.052 to 0.12
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 2
|
0.0014 pg mAb/ng total protein
Interval 0.0012 to 0.0014
|
0.0011 pg mAb/ng total protein
Interval 0.001 to 0.0012
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 4
|
0.14 pg mAb/ng total protein
Interval 0.14 to 0.15
|
0.49 pg mAb/ng total protein
Interval 0.46 to 0.51
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 8
|
0.17 pg mAb/ng total protein
Interval 0.16 to 0.19
|
0.58 pg mAb/ng total protein
Interval 0.46 to 0.62
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Female-Visit 9
|
0.014 pg mAb/ng total protein
Interval 0.0019 to 0.033
|
0.079 pg mAb/ng total protein
Interval 0.062 to 0.097
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 2
|
0.00095 pg mAb/ng total protein
Interval 0.00093 to 0.00095
|
0.00092 pg mAb/ng total protein
Interval 0.00086 to 0.0012
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Biopsy-Male-Visit 4
|
0.14 pg mAb/ng total protein
Interval 0.12 to 0.15
|
0.25 pg mAb/ng total protein
Interval 0.18 to 0.47
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 2
|
0.0024 pg mAb/ng total protein
Interval 0.0022 to 0.0029
|
0.0026 pg mAb/ng total protein
Interval 0.0019 to 0.0036
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 4
|
0.0025 pg mAb/ng total protein
Interval 0.0017 to 0.0027
|
0.003 pg mAb/ng total protein
Interval 0.0026 to 0.0037
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 5
|
0.002 pg mAb/ng total protein
Interval 0.0016 to 0.0025
|
0.0024 pg mAb/ng total protein
Interval 0.002 to 0.0048
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 6
|
0.0039 pg mAb/ng total protein
Interval 0.0025 to 0.0049
|
0.0035 pg mAb/ng total protein
Interval 0.0026 to 0.0042
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 7
|
0.0028 pg mAb/ng total protein
Interval 0.0024 to 0.0033
|
0.0029 pg mAb/ng total protein
Interval 0.0024 to 0.003
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 8
|
0.0037 pg mAb/ng total protein
Interval 0.0028 to 0.0041
|
0.0026 pg mAb/ng total protein
Interval 0.002 to 0.0028
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Female-Visit 9
|
0.0027 pg mAb/ng total protein
Interval 0.0023 to 0.003
|
0.0031 pg mAb/ng total protein
Interval 0.0024 to 0.0035
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 2
|
0.0039 pg mAb/ng total protein
Interval 0.0031 to 0.0048
|
0.003 pg mAb/ng total protein
Interval 0.0016 to 0.0034
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 4
|
0.0032 pg mAb/ng total protein
Interval 0.0029 to 0.0033
|
0.0027 pg mAb/ng total protein
Interval 0.0022 to 0.0034
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 5
|
0.0045 pg mAb/ng total protein
Interval 0.0036 to 0.0074
|
0.0029 pg mAb/ng total protein
Interval 0.002 to 0.0038
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 6
|
0.004 pg mAb/ng total protein
Interval 0.0032 to 0.0046
|
0.0025 pg mAb/ng total protein
Interval 0.0019 to 0.0037
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Rectal Secretions-Male-Visit 9
|
0.0032 pg mAb/ng total protein
Interval 0.0027 to 0.0036
|
0.0034 pg mAb/ng total protein
Interval 0.0029 to 0.0041
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 2
|
0.000044 pg mAb/ng total protein
Interval 0.000036 to 0.000044
|
0.000048 pg mAb/ng total protein
Interval 0.000045 to 0.000053
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 4
|
0.02 pg mAb/ng total protein
Interval 0.014 to 0.02
|
0.04 pg mAb/ng total protein
Interval 0.027 to 0.049
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 5
|
0.0028 pg mAb/ng total protein
Interval 0.0027 to 0.0043
|
0.0082 pg mAb/ng total protein
Interval 0.0057 to 0.011
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 7
|
0.0034 pg mAb/ng total protein
Interval 0.003 to 0.0047
|
0.0078 pg mAb/ng total protein
Interval 0.0045 to 0.0097
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 8
|
0.02 pg mAb/ng total protein
Interval 0.017 to 0.02
|
0.056 pg mAb/ng total protein
Interval 0.036 to 0.057
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Semen-Male-Visit 9
|
0.005 pg mAb/ng total protein
Interval 0.0045 to 0.0054
|
0.0091 pg mAb/ng total protein
Interval 0.0045 to 0.015
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 7
|
0.047 pg mAb/ng total protein
Interval 0.025 to 0.077
|
0.1 pg mAb/ng total protein
Interval 0.015 to 0.31
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 8
|
0.18 pg mAb/ng total protein
Interval 0.13 to 0.21
|
0.32 pg mAb/ng total protein
Interval 0.26 to 0.91
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Softcup Fluid-Female-Visit 9
|
0.021 pg mAb/ng total protein
Interval 0.014 to 0.029
|
0.011 pg mAb/ng total protein
Interval 0.0069 to 0.028
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 2
|
0.0016 pg mAb/ng total protein
Interval 0.0015 to 0.0021
|
0.003 pg mAb/ng total protein
Interval 0.0017 to 0.0038
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 8
|
0.17 pg mAb/ng total protein
Interval 0.13 to 0.23
|
0.26 pg mAb/ng total protein
Interval 0.0038 to 0.28
|
|
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Vaginal Biopsy-Female-Visit 9
|
0.04 pg mAb/ng total protein
Interval 0.0036 to 0.068
|
0.036 pg mAb/ng total protein
Interval 0.0048 to 0.071
|
PRIMARY outcome
Timeframe: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48).Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-IDiotype antibody (anti-ID). Outcome measure is the concentration of VRC07-523LS.
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 4
|
95.44 µg/mL
Interval 73.3 to 122.31
|
271.78 µg/mL
Interval 208.78 to 296.46
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 5
|
16.7 µg/mL
Interval 15.15 to 19.06
|
46.43 µg/mL
Interval 28.02 to 51.84
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 6
|
130.3 µg/mL
Interval 118.59 to 141.06
|
325.21 µg/mL
Interval 285.95 to 332.78
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 7
|
23.9 µg/mL
Interval 18.96 to 27.94
|
45.05 µg/mL
Interval 24.61 to 59.0
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 8
|
132.29 µg/mL
Interval 121.83 to 155.23
|
338.5 µg/mL
Interval 302.74 to 378.46
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 2
|
0.02 µg/mL
Interval 0.02 to 0.02
|
0.02 µg/mL
Interval 0.02 to 0.02
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 4
|
100.34 µg/mL
Interval 97.99 to 120.64
|
220.14 µg/mL
Interval 173.9 to 254.3
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 5
|
19.23 µg/mL
Interval 18.59 to 19.45
|
44.32 µg/mL
Interval 31.12 to 57.41
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 6
|
123.43 µg/mL
Interval 120.51 to 138.82
|
249.19 µg/mL
Interval 245.33 to 252.01
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 7
|
22.5 µg/mL
Interval 20.77 to 23.5
|
30.69 µg/mL
Interval 9.35 to 56.12
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 8
|
135.99 µg/mL
Interval 119.09 to 151.77
|
270.93 µg/mL
Interval 233.77 to 325.09
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 9
|
19.71 µg/mL
Interval 18.36 to 21.02
|
43.74 µg/mL
Interval 41.11 to 47.69
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 2
|
0.02 µg/mL
Interval 0.02 to 0.02
|
0.02 µg/mL
Interval 0.02 to 0.02
|
|
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 9
|
25.34 µg/mL
Interval 23.5 to 27.18
|
40.44 µg/mL
Interval 16.55 to 63.11
|
PRIMARY outcome
Timeframe: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48).Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-IDiotype antibody (anti-ID). Outcome measure is the IgG-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the average reference values for total IgG concentrations in serum in the USA (11,650,000 ng/mL).
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 6
|
10.59 pg mAb/ng total IgG
Interval 10.34 to 11.92
|
21.39 pg mAb/ng total IgG
Interval 21.06 to 21.63
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 7
|
1.93 pg mAb/ng total IgG
Interval 1.78 to 2.02
|
2.63 pg mAb/ng total IgG
Interval 0.8 to 4.82
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 8
|
11.67 pg mAb/ng total IgG
Interval 10.22 to 13.03
|
23.26 pg mAb/ng total IgG
Interval 20.07 to 27.9
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 9
|
1.69 pg mAb/ng total IgG
Interval 1.58 to 1.8
|
3.75 pg mAb/ng total IgG
Interval 3.53 to 4.09
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 2
|
0.002 pg mAb/ng total IgG
Interval 0.002 to 0.002
|
0.002 pg mAb/ng total IgG
Interval 0.002 to 0.002
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 4
|
8.19 pg mAb/ng total IgG
Interval 6.29 to 10.5
|
23.33 pg mAb/ng total IgG
Interval 17.92 to 25.45
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 2
|
0.002 pg mAb/ng total IgG
Interval 0.002 to 0.002
|
0.002 pg mAb/ng total IgG
Interval 0.002 to 0.002
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 4
|
8.61 pg mAb/ng total IgG
Interval 8.41 to 10.36
|
18.9 pg mAb/ng total IgG
Interval 14.93 to 21.83
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 5
|
1.65 pg mAb/ng total IgG
Interval 1.6 to 1.67
|
3.8 pg mAb/ng total IgG
Interval 2.67 to 4.93
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 5
|
1.43 pg mAb/ng total IgG
Interval 1.3 to 1.64
|
3.99 pg mAb/ng total IgG
Interval 2.4 to 4.45
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 6
|
11.18 pg mAb/ng total IgG
Interval 10.18 to 12.11
|
27.92 pg mAb/ng total IgG
Interval 24.55 to 28.56
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 7
|
2.05 pg mAb/ng total IgG
Interval 1.63 to 2.4
|
3.87 pg mAb/ng total IgG
Interval 2.11 to 5.06
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 8
|
11.36 pg mAb/ng total IgG
Interval 10.46 to 13.32
|
29.06 pg mAb/ng total IgG
Interval 25.99 to 32.49
|
|
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 9
|
2.18 pg mAb/ng total IgG
Interval 2.02 to 2.33
|
3.47 pg mAb/ng total IgG
Interval 1.42 to 5.42
|
PRIMARY outcome
Timeframe: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48).Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the protein-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total protein (ng/mL).
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 9
|
0.2 pg mAb/ng total protein
Interval 0.19 to 0.21
|
0.49 pg mAb/ng total protein
Interval 0.45 to 0.56
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 2
|
0.00025 pg mAb/ng total protein
Interval 0.00025 to 0.00026
|
0.00023 pg mAb/ng total protein
Interval 0.00023 to 0.00025
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 7
|
0.24 pg mAb/ng total protein
Interval 0.19 to 0.28
|
0.45 pg mAb/ng total protein
Interval 0.22 to 0.58
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 8
|
1.46 pg mAb/ng total protein
Interval 1.29 to 1.63
|
3.08 pg mAb/ng total protein
Interval 3.05 to 3.86
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 9
|
0.25 pg mAb/ng total protein
Interval 0.23 to 0.27
|
0.35 pg mAb/ng total protein
Interval 0.16 to 0.54
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 2
|
0.00022 pg mAb/ng total protein
Interval 0.00022 to 0.00022
|
0.00026 pg mAb/ng total protein
Interval 0.00025 to 0.00027
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 4
|
0.97 pg mAb/ng total protein
Interval 0.92 to 1.22
|
2.32 pg mAb/ng total protein
Interval 1.95 to 2.69
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 5
|
0.19 pg mAb/ng total protein
Interval 0.18 to 0.2
|
0.45 pg mAb/ng total protein
Interval 0.34 to 0.58
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 6
|
1.25 pg mAb/ng total protein
Interval 1.23 to 1.37
|
2.56 pg mAb/ng total protein
Interval 2.54 to 2.78
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 7
|
0.22 pg mAb/ng total protein
Interval 0.21 to 0.25
|
0.35 pg mAb/ng total protein
Interval 0.1 to 0.56
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Female-Visit 8
|
1.3 pg mAb/ng total protein
Interval 1.13 to 1.49
|
3 pg mAb/ng total protein
Interval 2.81 to 3.47
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 4
|
1 pg mAb/ng total protein
Interval 0.78 to 1.33
|
2.74 pg mAb/ng total protein
Interval 2.17 to 2.98
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 5
|
0.19 pg mAb/ng total protein
Interval 0.17 to 0.2
|
0.49 pg mAb/ng total protein
Interval 0.31 to 0.59
|
|
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Serum-Male-Visit 6
|
1.33 pg mAb/ng total protein
Interval 1.22 to 1.41
|
3.08 pg mAb/ng total protein
Interval 2.89 to 3.71
|
SECONDARY outcome
Timeframe: Measured at Visits 2, 3, 5, 7, and 9 (Weeks -2, 0, 16, 32, 48). However, Tier 3 ADA titers are only assessed and reported at Visits 2 and 3 (Weeks -2 and 0) for the subset of participants who tested positive for ADA Tiers 1 and 2.Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria at each timepoint.
Anti-drug dependent antibodies were measured by an ADA assay from specimens obtained from all participants. Tier 3 titers are only available for those participants who had positive for ADA Tiers 1 and 2.
Outcome measures
| Measure |
Group 1: Vaccine
n=11 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 Participants
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
|---|---|---|
|
Serum Concentration of ADA in Each Group Measured at Multiple Timepoints From Baseline Through the Final Study Visit
VRC07-523LS-Tier 3-Visit 2
|
15 Titer
Interval 9.0 to 21.0
|
54 Titer
Interval 40.5 to 67.5
|
|
Serum Concentration of ADA in Each Group Measured at Multiple Timepoints From Baseline Through the Final Study Visit
VRC07-523LS-Tier 3-Visit 3
|
15 Titer
Interval 9.0 to 21.0
|
27 Titer
Interval 27.0 to 27.0
|
Adverse Events
Group 1: Vaccine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2: Vaccine
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 3: Pre-treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Vaccine
n=11 participants at risk
VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 2: Vaccine
n=13 participants at risk
VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
|
Group 3: Pre-treatment
n=4 participants at risk
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|
|
Ear and labyrinth disorders
Any Event in SOC
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Ear and labyrinth disorders
Vertigo positional
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Eye disorders
Any Event in SOC
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Eye disorders
Chalazion
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Gastrointestinal disorders
Any Event in SOC
|
36.4%
4/11 • Number of events 4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
2/11 • Number of events 2 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Gastrointestinal disorders
Oral pruritus
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
General disorders
Any Event in SOC
|
18.2%
2/11 • Number of events 2 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
General disorders
Feeling cold
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
General disorders
Influenza like illness
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Any Event in SOC
|
81.8%
9/11 • Number of events 24 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
38.5%
5/13 • Number of events 5 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Bacterial vaginosis
|
27.3%
3/11 • Number of events 4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Bronchitis
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Gastroenteritis
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Hordeolum
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Otitis externa
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Upper respiratory tract infection
|
72.7%
8/11 • Number of events 11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
23.1%
3/13 • Number of events 3 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Viral infection
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
18.2%
2/11 • Number of events 4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
27.3%
3/11 • Number of events 4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
53.8%
7/13 • Number of events 7 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
18.2%
2/11 • Number of events 3 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
38.5%
5/13 • Number of events 5 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Muscle injury
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Any Event in SOC
|
27.3%
3/11 • Number of events 6 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
15.4%
2/13 • Number of events 2 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Blood creatinine increased
|
18.2%
2/11 • Number of events 2 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Blood pressure increased
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Smear cervix abnormal
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Metabolism and nutrition disorders
Any Event in SOC
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
27.3%
3/11 • Number of events 3 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
15.4%
2/13 • Number of events 2 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Any Event in SOC
|
27.3%
3/11 • Number of events 3 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
30.8%
4/13 • Number of events 4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Disturbance in attention
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Dizziness postural
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Migraine
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Psychiatric disorders
Any Event in SOC
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Psychiatric disorders
Depression
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Renal and urinary disorders
Any Event in SOC
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Renal and urinary disorders
Dysuria
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
18.2%
2/11 • Number of events 2 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
18.2%
2/11 • Number of events 2 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.1%
1/11 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/13 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
7.7%
1/13 • Number of events 1 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/4 • Enrollment through week 48
Number of Participants Reporting Adverse Events (AEs)
|
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