Trial Outcomes & Findings for Phase I Study to Evaluate a Human Monoclonal Antibody (MAb) 10E8VLS Administered Alone or Concurrently With MAb VRC07-523LS Via Subcutaneous Injection in Healthy Adults (NCT NCT03565315)

Last Updated: 2020-12-30

Results Overview

Local symptoms were recorded by participants using a 3-day diary. Solicited local symptoms include pain/tenderness, bruising, redness, swelling, and pruritus (itchiness) at the product administration site. Clinicians reviewed the diary with the participant and collected resolution information for any symptoms that were not resolved within 3 days. Participants were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

3 days after product administration

Results posted on

2020-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 3: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Multiple Dose Group* (Only One Dose Received) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
Overall Study STARTED	3	3	1	2
Overall Study Product Administration Completed	3	0	1	0
Overall Study Discontinued Product Administrations	0	3	0	2
Overall Study COMPLETED	3	3	1	1
Overall Study NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 3: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Multiple Dose Group* (Only One Dose Received) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
Overall Study IND Sponsor/PI Voluntary Study Pause	0	0	0	1

Baseline Characteristics

Phase I Study to Evaluate a Human Monoclonal Antibody (MAb) 10E8VLS Administered Alone or Concurrently With MAb VRC07-523LS Via Subcutaneous Injection in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=3 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) n=3 Participants 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 3: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Single Dose Group n=1 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Multiple Dose Group* (Only One Dose Received) n=2 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Total n=9 Participants Total of all reporting groups
Age, Continuous	29.7 years STANDARD_DEVIATION 16.1 • n=5 Participants	27.7 years STANDARD_DEVIATION 5.0 • n=7 Participants	40.0 years STANDARD_DEVIATION 0.0 • n=5 Participants	45.0 years STANDARD_DEVIATION 15.6 • n=4 Participants	33.6 years STANDARD_DEVIATION 12.6 • n=21 Participants
Age, Customized 18-20 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Age, Customized 21-30 years	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Age, Customized 31-40 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Age, Customized 41-50 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Age, Customized 51-60 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Weight (kg)	81.7 kilograms STANDARD_DEVIATION 15.1 • n=5 Participants	80.1 kilograms STANDARD_DEVIATION 18.4 • n=7 Participants	91.1 kilograms STANDARD_DEVIATION 0.0 • n=5 Participants	75.7 kilograms STANDARD_DEVIATION 1.3 • n=4 Participants	80.9 kilograms STANDARD_DEVIATION 12.8 • n=21 Participants

PRIMARY outcome

Timeframe: 3 days after product administration

Population: Participants in Groups 1 and 2 (N=6) received 10E8VLS and Groups 3 and 4 (N=2) received 10E8VLS+VRC07-523LS. Participants in Groups 2 and 4 were assigned to receive 3 repeat product administrations but received only 1 due to the voluntary termination of study product administration by the IND sponsor. The 2nd and 3rd doses for the 3 Group 2 participants assigned to receive 10E8VLS, and the single Group 4 participant assigned to receive 10E8VLS+VRC07-523LS were not administered.

Outcome measures

Outcome measures
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=3 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) n=3 Participants 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Overall 10E8VLS Groups n=6 Participants Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS	Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group n=1 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) n=1 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups n=2 Participants Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently	Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group n=1 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) n=1 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups n=2 Participants Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Pruritus · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Pain/Tenderness · None	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Pain/Tenderness · Mild	3 Participants	3 Participants	6 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Pain/Tenderness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Pain/Tenderness · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Bruising · None	2 Participants	2 Participants	4 Participants	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Bruising · Mild	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Bruising · Moderate	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Bruising · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Redness · None	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Redness · Mild	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Redness · Moderate	2 Participants	2 Participants	4 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Redness · Severe	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Swelling · None	0 Participants	3 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Swelling · Mild	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Swelling · Moderate	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Swelling · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Pruritus · None	3 Participants	2 Participants	5 Participants	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Pruritus · Mild	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Pruritus · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Any Local Symptom Reported · None	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Any Local Symptom Reported · Mild	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Any Local Symptom Reported · Moderate	2 Participants	2 Participants	4 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Any Local Symptom Reported · Severe	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 3 days after product administration

Participants recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Participants recorded highest measured temperature daily. Clinicians reviewed the diary with the participant and collected resolution information for any symptoms that were not resolved within 3 days. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.

Outcome measures

Outcome measures
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=3 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) n=3 Participants 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Overall 10E8VLS Groups n=6 Participants Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS	Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group n=1 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) n=1 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups n=2 Participants Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently	Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Joint Pain · None	3 Participants	3 Participants	6 Participants	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Joint Pain · Mild	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Joint Pain · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Joint Pain · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Any Systemic Symptom · None	2 Participants	2 Participants	4 Participants	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Any Systemic Symptom · Mild	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Any Systemic Symptom · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Any Systemic Symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Malaise · None	2 Participants	3 Participants	5 Participants	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Malaise · Mild	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Malaise · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Malaise · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Myalgia · None	3 Participants	2 Participants	5 Participants	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Myalgia · Mild	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Myalgia · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Myalgia · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Headache · None	3 Participants	3 Participants	6 Participants	1 Participants	1 Participants	2 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Headache · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Headache · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Headache · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Chills · None	3 Participants	3 Participants	6 Participants	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Chills · Mild	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Chills · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Chills · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Nausea · None	2 Participants	3 Participants	5 Participants	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Nausea · Mild	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Nausea · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Nausea · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Temperature · None	3 Participants	3 Participants	6 Participants	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Temperature · Mild	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Temperature · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration Temperature · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to 24 weeks after product administration

Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after product administration. After the indicated time period through the last expected study visit at 24 weeks after product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of participants who experienced at least one AE in the reporting period. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Outcome measures

Outcome measures
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=3 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) n=3 Participants 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Overall 10E8VLS Groups n=1 Participants Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS	Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group n=1 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) n=8 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently	Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
Number of Participants With One or More Unsolicited Non-Serious Adverse Events Related to 10E8VLS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Number of Participants With One or More Unsolicited Non-Serious Adverse Events Related to VRC07-523LS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—
Number of Participants With One or More Unsolicited Non-Serious Adverse Events Unrelated to 10E8VLS or VRC07-523LS	2 Participants	2 Participants	0 Participants	0 Participants	4 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Up to 24 weeks after product administration

Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the product administration.

Outcome measures

Outcome measures
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=3 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) n=3 Participants 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Overall 10E8VLS Groups n=1 Participants Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS	Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group n=1 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) n=8 Participants 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently	Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
Number of Participants With Serious Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 24 weeks after product administration

Population: Participants received 10E8VLS administered alone or concurrently with VRC07-523LS (N=8), where "N" signifies the number analyzed. The overall population (N=8) was analyzed for this measure as all study groups received only one 10E8VLS administration. Due to voluntary termination of study product administration by the IND sponsor, 2nd and 3rd administrations for the 3 participants assigned to receive 10E8VLS, and the one participant assigned to receive 10E8VLS+VRC07-523LS were not administered.

Cmax is the peak serum concentration that 10E8VLS achieves after it has been administered: it is determined as maximum value on the summary pharmacokinetic (PK) curve for the overall study population. Serum was collected at the following time points: Groups 1 and 3: Pre-injection (baseline), and 24, 48 and 72 hours post injection, followed by Weeks 1-4, 8, 12, 16, 20 and 24 post-injection; Groups 2 and 4: Pre-injection (baseline), and 24, 48 and 72 hours post injection, and Weeks 1, 2, 4, 8, 12-14, 16, 20 and 24 post injection

Outcome measures

Outcome measures
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=8 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Overall 10E8VLS Groups Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS	Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently	Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
Maximum Observed Serum Concentration (Cmax) of 10E8VLS Administered Alone or Concurrently With VRC07-523LS	28.3 µg/mL Standard Deviation 11.1	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 24 weeks after product administration

Tmax is the time it takes to reach Cmax of 10E8VLS after it has been administered; it is determined based on the summary PK curve for the overall study population. Serum was collected at the following time points: Groups 1 and 3: Pre-injection (baseline), and 24, 48 and 72 hours post injection, followed by Weeks 1-4, 8, 12, 16, 20 and 24 post-injection; Groups 2 and 4: Pre-injection (baseline), and 24, 48 and 72 hours post injection, and Weeks 1, 2, 4, 8, 12-14, 16, 20 and 24 post injection

Outcome measures

Outcome measures
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=8 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Overall 10E8VLS Groups Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS	Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently	Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
Time to Reach Maximum Observed Serum Concentration (Tmax) of 10E8VLS Administered Alone or Concurrently With VRC07-523LS	2.6 days Standard Deviation 0.5	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Administration (0h) up to 28 days after product administration

The AUC0-28D represents the total drug exposure in 28 days after 10E8VLS administration; it is determined based on the summary PK curve for the overall study population. Serum was collected at the following time points: Groups 1 and 3: Pre-injection (baseline), and 24, 48 and 72 hours post injection, followed by Weeks 1, 2, 3 and 4 post injection; Groups 2 and 4: Pre-injection (baseline) and 24, 48 and 72 hours post injection and Weeks 1, 2 and 4 post injection.

Outcome measures

Outcome measures
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=8 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Overall 10E8VLS Groups Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS	Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently	Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
Area Under the Curve (AUC0-28D) of 10E8VLS Administered Alone or Concurrently With VRC07-523LS	322 µg*d/mL Standard Deviation 114	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Administration (0h) up to 28 days after product administration

The mean of individual participant 10E8VLS serum concentrations. The overall population was analyzed as all participants received only one 10E8VLS administration.

Outcome measures

Outcome measures
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=8 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Overall 10E8VLS Groups Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS	Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently	Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
4 Week Mean Serum Concentration of 10E8VLS Administered Alone or Concurrently With VRC07-523LS	3.06 µg/mL Standard Deviation 1.22	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Administration (0h) up to 28 days after product administration

Rate of 10E8VLS elimination divided by the plasma 10E8VLS concentration; determined based on the summary PK curve for the overall study population. Serum was collected at the following time points: Groups 1 and 3: Pre-injection (baseline), and 24, 48 and 72 hours post injection, followed by Weeks 1, 2, 3 and 4 post injection; Groups 2 and 4: Pre-injection (baseline) and 24, 48 and 72 hours post injection and Weeks 1, 2 and 4 post injection.

Outcome measures

Outcome measures
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=8 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Overall 10E8VLS Groups Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS	Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently	Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
Clearance Rate of 10E8VLS Administered Alone or Concurrently With VRC07-523LS	1309 mL/d Standard Deviation 496	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Administration (0h) up to 28 days after product administration

Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum. Serum was collected at the following time points: Groups 1 and 3: Pre-injection (baseline), and 24, 48 and 72 hours post injection, followed by Weeks 1, 2, 3 and 4 post injection; Groups 2 and 4: Pre-injection (baseline) and 24, 48 and 72 hours post injection and Weeks 1, 2 and 4 post injection.

Outcome measures

Outcome measures
Measure	Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group n=8 Participants 10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (Only One Dose Received) 10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.	Overall 10E8VLS Groups Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS	Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently	Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0) VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (Only 1 Dose) 10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12\, Week 24\) \Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision. VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1. VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
Overall Half-Life (T1/2) of 10E8VLS Administered Alone or Concurrently With VRC07-523LS	8.1 days Standard Deviation 1.5	—	—	—	—	—	—	—	—

Adverse Events

Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (*Only One Dose Received)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 3: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Single Dose Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 4: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Multiple Dose Group* (*Only One Dose Received)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Martin Gaudinski, MD

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health

Phone: 301-451-8715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place