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VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015181
Recruitment Status : Completed
First Posted : January 9, 2017
Results First Posted : July 11, 2019
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HIV Prevention
Intervention Biological: VRC-HIVMAB075-00-AB
Enrollment 26
Recruitment Details Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.
Pre-assignment Details  
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 3: 5 mg/kg SC Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 6: 5 mg/kg SC Multiple Doses Group 7: 20 mg/kg IV Multiple Doses
Hide Arm/Group Description

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Period Title: Overall Study
Started 4 3 3 3 3 5 5
Received VRC07-523LS Per Protocol 3 3 3 3 3 4 4
Discontinued VRC07-523LS Administrations 1 [1] 0 0 0 0 1 [2] 1 [3]
Completed 3 3 3 3 3 4 [4] 4 [5]
Not Completed 1 0 0 0 0 1 1
Reason Not Completed
Enrolled, but product never administered             1             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             1             0
Physician Decision             0             0             0             0             0             0             1
[1]
One Group 1 subject decided not to receive the VRC07-523LS infusion
[2]
One Group 6 subject received only 1 of 3 scheduled doses prior to withdrawing from the study
[3]
One Group 7 subject received only 1 of 3 scheduled doses due to an unrelated intercurrent illness
[4]
Group 6 subject who received only 1 dose chose to withdraw from study after the first administration
[5]
Group 7 subject who received only 1 dose was withdrawn after unrelated intercurrent illness resolved
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 3: 5 mg/kg SC Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 6: 5 mg/kg SC Multiple Doses Group 7: 20 mg/kg IV Multiple Doses Total
Hide Arm/Group Description

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total of all reporting groups
Overall Number of Baseline Participants 4 3 3 3 3 5 5 26
Hide Baseline Analysis Population Description
Population includes all enrolled subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 3 participants 3 participants 3 participants 5 participants 5 participants 26 participants
26.5  (7.0) 28.0  (9.5) 30.0  (7.0) 27.0  (2.6) 40.0  (10.4) 25.8  (4.1) 30.0  (10.6) 29.2  (8.1)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 3 participants 3 participants 3 participants 5 participants 5 participants 26 participants
21-30 years
3
  75.0%
2
  66.7%
2
  66.7%
3
 100.0%
1
  33.3%
4
  80.0%
3
  60.0%
18
  69.2%
31-40 years
1
  25.0%
1
  33.3%
1
  33.3%
0
   0.0%
0
   0.0%
1
  20.0%
1
  20.0%
5
  19.2%
41-50 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  66.7%
0
   0.0%
1
  20.0%
3
  11.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 3 participants 3 participants 3 participants 5 participants 5 participants 26 participants
Female
2
  50.0%
2
  66.7%
0
   0.0%
1
  33.3%
3
 100.0%
5
 100.0%
2
  40.0%
15
  57.7%
Male
2
  50.0%
1
  33.3%
3
 100.0%
2
  66.7%
0
   0.0%
0
   0.0%
3
  60.0%
11
  42.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 3 participants 3 participants 3 participants 5 participants 5 participants 26 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  33.3%
1
  33.3%
1
  33.3%
1
  20.0%
0
   0.0%
4
  15.4%
Not Hispanic or Latino
4
 100.0%
3
 100.0%
2
  66.7%
2
  66.7%
2
  66.7%
4
  80.0%
5
 100.0%
22
  84.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 3 participants 3 participants 3 participants 5 participants 5 participants 26 participants
Asian
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
1
  20.0%
3
  11.5%
Black or African American
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
  20.0%
3
  11.5%
White
2
  50.0%
2
  66.7%
2
  66.7%
2
  66.7%
1
  33.3%
4
  80.0%
3
  60.0%
16
  61.5%
Multiracial
1
  25.0%
0
   0.0%
1
  33.3%
1
  33.3%
1
  33.3%
0
   0.0%
0
   0.0%
4
  15.4%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 4 participants 3 participants 3 participants 3 participants 3 participants 5 participants 5 participants 26 participants
75.8  (4.6) 65.5  (17.3) 89.4  (15.0) 75.9  (11.0) 67.2  (20.1) 55.2  (7.1) 76.1  (11.4) 71.3  (14.9)
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 3 participants 3 participants 3 participants 5 participants 5 participants 26 participants
High school graduate/GeneralEducationalDevelopment
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
2
   7.7%
College/University
2
  50.0%
2
  66.7%
2
  66.7%
2
  66.7%
2
  66.7%
4
  80.0%
4
  80.0%
18
  69.2%
Advanced degree
1
  25.0%
1
  33.3%
1
  33.3%
1
  33.3%
0
   0.0%
1
  20.0%
1
  20.0%
6
  23.1%
1.Primary Outcome
Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration
Hide Description Subjects 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. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects 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 subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.
Time Frame 3 days after each product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses.
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 7: 20 mg/kg IV Multiple Doses: Dose 1 Group 7: 20 mg/kg IV Multiple Doses: Dose 2 Group 7: 20 mg/kg IV Multiple Doses: Dose 3 Overall IV Groups Group 3: 5 mg/kg SC Single Dose Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Overall SC Groups
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Overall Number of Participants Analyzed 3 3 3 3 5 4 4 17 3 5 4 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
Malaise None
3
 100.0%
3
 100.0%
3
 100.0%
2
  66.7%
3
  60.0%
3
  75.0%
3
  75.0%
14
  82.4%
3
 100.0%
2
  40.0%
4
 100.0%
4
 100.0%
5
  62.5%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  40.0%
1
  25.0%
1
  25.0%
2
  11.8%
0
   0.0%
3
  60.0%
0
   0.0%
0
   0.0%
3
  37.5%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Myalgia None
3
 100.0%
2
  66.7%
3
 100.0%
2
  66.7%
4
  80.0%
3
  75.0%
3
  75.0%
14
  82.4%
3
 100.0%
3
  60.0%
4
 100.0%
4
 100.0%
6
  75.0%
Mild
0
   0.0%
1
  33.3%
0
   0.0%
1
  33.3%
1
  20.0%
1
  25.0%
0
   0.0%
2
  11.8%
0
   0.0%
2
  40.0%
0
   0.0%
0
   0.0%
2
  25.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Headache None
3
 100.0%
3
 100.0%
3
 100.0%
2
  66.7%
4
  80.0%
3
  75.0%
4
 100.0%
15
  88.2%
3
 100.0%
3
  60.0%
3
  75.0%
4
 100.0%
5
  62.5%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
  20.0%
1
  25.0%
0
   0.0%
2
  11.8%
0
   0.0%
2
  40.0%
1
  25.0%
0
   0.0%
3
  37.5%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chills None
3
 100.0%
3
 100.0%
3
 100.0%
2
  66.7%
4
  80.0%
3
  75.0%
3
  75.0%
15
  88.2%
3
 100.0%
4
  80.0%
4
 100.0%
4
 100.0%
7
  87.5%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
1
  12.5%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
  20.0%
1
  25.0%
1
  25.0%
2
  11.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea None
3
 100.0%
3
 100.0%
3
 100.0%
2
  66.7%
5
 100.0%
4
 100.0%
4
 100.0%
16
  94.1%
3
 100.0%
4
  80.0%
4
 100.0%
4
 100.0%
7
  87.5%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
1
  12.5%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Temperature None
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
4
  80.0%
4
 100.0%
4
 100.0%
16
  94.1%
3
 100.0%
5
 100.0%
4
 100.0%
4
 100.0%
8
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Joint Pain None
3
 100.0%
3
 100.0%
3
 100.0%
2
  66.7%
5
 100.0%
4
 100.0%
3
  75.0%
15
  88.2%
3
 100.0%
3
  60.0%
4
 100.0%
4
 100.0%
6
  75.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
2
  40.0%
0
   0.0%
0
   0.0%
2
  25.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Systemic Symptom Reported None
3
 100.0%
2
  66.7%
3
 100.0%
2
  66.7%
3
  60.0%
3
  75.0%
3
  75.0%
13
  76.5%
3
 100.0%
1
  20.0%
3
  75.0%
4
 100.0%
3
  37.5%
Mild
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
2
  11.8%
0
   0.0%
4
  80.0%
1
  25.0%
0
   0.0%
5
  62.5%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
  20.0%
1
  25.0%
1
  25.0%
2
  11.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration
Hide Description Local symptoms assessed and recorded by the clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that was not resolved within 7 days. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity recorded without an attribution assessment. If symptoms were reported, grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.
Time Frame 7 days after each product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses.
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 7: 20 mg/kg IV Multiple Doses: Dose 1 Group 7: 20 mg/kg IV Multiple Doses: Dose 2 Group 7: 20 mg/kg IV Multiple Doses: Dose 3 Overall IV Groups Group 3: 5 mg/kg SC Single Dose Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Overall SC Groups
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Overall Number of Participants Analyzed 3 3 3 3 5 4 4 17 3 5 4 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
Pain/Tenderness None
3
 100.0%
3
 100.0%
2
  66.7%
3
 100.0%
5
 100.0%
4
 100.0%
4
 100.0%
16
  94.1%
2
  66.7%
2
  40.0%
1
  25.0%
2
  50.0%
4
  50.0%
Mild
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
1
  33.3%
3
  60.0%
3
  75.0%
2
  50.0%
4
  50.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bruising None
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
4
  80.0%
4
 100.0%
4
 100.0%
16
  94.1%
3
 100.0%
5
 100.0%
4
 100.0%
4
 100.0%
8
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Swelling None
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
5
 100.0%
4
 100.0%
4
 100.0%
17
 100.0%
3
 100.0%
5
 100.0%
4
 100.0%
4
 100.0%
8
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Redness None
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
5
 100.0%
4
 100.0%
4
 100.0%
17
 100.0%
3
 100.0%
5
 100.0%
4
 100.0%
3
  75.0%
7
  87.5%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
  12.5%
Pruritus None
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
5
 100.0%
4
 100.0%
4
 100.0%
17
 100.0%
3
 100.0%
5
 100.0%
4
 100.0%
4
 100.0%
8
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Local Symptom Reported None
3
 100.0%
3
 100.0%
2
  66.7%
3
 100.0%
4
  80.0%
4
 100.0%
4
 100.0%
15
  88.2%
2
  66.7%
2
  40.0%
1
  25.0%
1
  25.0%
4
  50.0%
Mild
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
2
  11.8%
1
  33.3%
3
  60.0%
3
  75.0%
2
  50.0%
3
  37.5%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
  12.5%
3.Primary Outcome
Title Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events
Hide Description Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after the last product administration. After the indicated time period through the last expected study visit at 24 weeks after the last product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity.
Time Frame Through 24 weeks after the last product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure.
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 3: 5 mg/kg SC Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 6: 5 mg/kg SC Multiple Doses Group 7: 20 mg/kg IV Multiple Doses Overall
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total number of subjects who received VRC07-523LS (VRC-HIVMAB075-00-AB)
Overall Number of Participants Analyzed 3 3 3 3 3 5 5 25
Measure Type: Count of Participants
Unit of Measure: Participants
Related to study product
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  66.7%
0
   0.0%
2
  40.0%
4
  16.0%
Unrelated to study product
2
  66.7%
1
  33.3%
1
  33.3%
0
   0.0%
0
   0.0%
5
 100.0%
3
  60.0%
12
  48.0%
4.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the last product administration.
Time Frame Through 24 weeks after the last product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure.
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 3: 5 mg/kg SC Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 6: 5 mg/kg SC Multiple Doses Group 7: 20 mg/kg IV Multiple Doses Overall
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total number of subjects who received VRC07-523LS (VRC-HIVMAB075-00-AB)
Overall Number of Participants Analyzed 3 3 3 3 3 5 5 25
Measure Type: Count of Participants
Unit of Measure: Participants
Related to study product
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unrelated to study product
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Single Dose Groups
Hide Description

Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.

Serum was collected at the following time points:

Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection

Time Frame Up to 24 weeks post product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 3: 5 mg/kg SC Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Overall Number of Participants Analyzed 3 3 3 4 3
Mean (Standard Deviation)
Unit of Measure: µg/mL
47  (16) 240  (35) 50  (11) 869  (190) 1630  (644)
6.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups
Hide Description

Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.

Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:

Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion

Time Frame Through 24 weeks after the last product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, values calculated from 4 subjects per group.
Arm/Group Title Group 6: 5 mg/kg SC Multiple Doses Group 7: 20 mg/kg IV Multiple Doses
Hide Arm/Group Description:

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: µg/mL
Dose 1 Number Analyzed 5 participants 4 participants
38  (17) 1196  (74)
Dose 3 Number Analyzed 4 participants 4 participants
37  (12) 799  (98)
7.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC07-523LS
Hide Description

Tmax is the time it takes to reach Cmax of VRC07-523LS after it has been administered; it is determined based on the summary PK curve for each study group

Serum was collected at the following time points:

Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion

Time Frame Through 24 weeks after the last product administration for Groups 1-5 and through 8 weeks after the last product administration for Groups 6 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 3: 5 mg/kg SC Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 6: 5 mg/kg SC Multiple Doses Group 7: 20 mg/kg IV Multiple Doses
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Overall Number of Participants Analyzed 3 3 3 4 3 5 4
Mean (Standard Deviation)
Unit of Measure: days
0.7  (0.5) 0.04  (0.02) 10  (9.5) 0.3  (0.4) 0.04  (0.02) 5.7  (5.0) 0.04  (0.02)
8.Secondary Outcome
Title 4 Week Mean Serum Concentration of VRC07-523LS
Hide Description The mean of individual subject VRC07-523LS serum concentrations by administered dose group
Time Frame Week 4 post product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 3: 5 mg/kg SC Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 6: 5 mg/kg SC Multiple Doses Group 7: 20 mg/kg IV Multiple Doses
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Overall Number of Participants Analyzed 3 3 3 4 3 5 4
Mean (Standard Deviation)
Unit of Measure: µg/mL
14  (7.5) 57  (11) 31  (11) 148  (28) 272  (52) 25  (13) 242  (51)
9.Secondary Outcome
Title 12 Week Mean Serum Concentration of VRC07-523LS: Single Dose Groups
Hide Description The mean of individual subject VRC07-523LS serum concentrations by administered dose group
Time Frame Week 12 post product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 3: 5 mg/kg SC Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Overall Number of Participants Analyzed 3 3 3 4 3
Mean (Standard Deviation)
Unit of Measure: µg/mL
3.8  (0.7) 57  (11) 7.1  (1.3) 44  (14) 85  (30)
10.Secondary Outcome
Title 12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups
Hide Description The mean of individual subject VRC07-523LS serum concentrations by administered dose group
Time Frame Up to 12 weeks after each product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, values calculated from 4 subjects per group.
Arm/Group Title Group 6: 5 mg/kg SC Multiple Doses Group 7: 20 mg/kg IV Multiple Doses
Hide Arm/Group Description:

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: µg/mL
Dose 1 Number Analyzed 5 participants 4 participants
6.3  (1.5) 46  (13)
Dose 3 Number Analyzed 4 participants 4 participants
9.8  (2.5) 71  (29)
11.Secondary Outcome
Title Area Under the Curve (AUC(0-inf)): Single Dose Groups
Hide Description

The total area under the curve (AUC(inf)) was taken as the sum of the observed AUC up to the final concentration (AUC(obs)) plus the AUC after the final concentration (AUC(Clast-inf)) where AUC(Clast-inf) was estimated as Clast/lz.

Serum was collected at the following time points:

Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection

Time Frame Administration (0h) to 24 weeks post product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 3: 5 mg/kg SC Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Overall Number of Participants Analyzed 3 3 3 4 3
Mean (Standard Deviation)
Unit of Measure: µg*d/mL
1381  (325) 4551  (904) 2189  (309) 13748  (1853) 25517  (5097)
12.Secondary Outcome
Title Area Under the Curve (AUC0-84D): Multiple Dose Groups
Hide Description

The AUC0-84D represents the total drug exposure in 84 days after VRC07-523LS administration; it is determined based on the summary PK curve for each group.

Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:

Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion

Time Frame Administration (0h) up to 84 days after each product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, value calculated from 4 subjects per group.
Arm/Group Title Group 6: 5 mg/kg SC Multiple Doses Group 7: 20 mg/kg IV Multiple Doses
Hide Arm/Group Description:

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: µg*d/mL
Dose 1 Number Analyzed 5 participants 4 participants
1440  (563) 14760  (2646)
Dose 3 Number Analyzed 4 participants 4 participants
1671  (443) 13573  (1115)
13.Secondary Outcome
Title VRC07-523LS Clearance Rate
Hide Description

Rate of VRC07-523LS elimination divided by the plasma VRC07-523LS concentration; determined based on the summary PK curve for each study group.

Serum was collected at the following time points:

Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2 and 4 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2 and 4 post infusion

Time Frame Administration (0h) to 28 days post product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). Value following SC administration represents CL/F (apparent clearance).
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 7: 20 mg/kg IV Multiple Doses Overall IV Groups Group 3: 5 mg/kg SC Single Dose Group 6: 5 mg/kg SC Multiple Doses Overall SC Groups
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Overall Number of Participants Analyzed 3 3 4 3 4 17 3 5 8
Mean (Standard Deviation)
Unit of Measure: mL/day
70  (20) 78  (18) 110  (19) 105  (14) 101  (15) 94  (22) 226  (54) 158  (34) 184  (52)
14.Secondary Outcome
Title Overall IV Half-life (T1/2) of VRC07-523LS
Hide Description

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, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 and 8 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 and 8 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion

Time Frame Administration (0h) to 56 days post product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 7: 20 mg/kg IV Multiple Doses Overall IV Groups Group 3: 5 mg/kg SC Single Dose Group 6: 5 mg/kg SC Multiple Doses Overall SC Groups
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Overall Number of Participants Analyzed 3 3 4 3 4 17 3 5 8
Mean (Standard Deviation)
Unit of Measure: days
48  (26) 32  (1.1) 45  (5.2) 42  (5.1) 27  (1.8) 38  (12) 36  (6.7) 31  (10) 33  (8.9)
15.Secondary Outcome
Title Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS
Hide Description Serum samples collected 4 weeks and 8 weeks after VRC07-523LS administration
Time Frame Weeks 4 and 8 post product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received a single dose of VRC07-523LS via SC or IV administration. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4.
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 3: 5 mg/kg SC Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Overall Number of Participants Analyzed 3 3 3 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4: Subjects with Anti-Drug Antibodies
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8: Subjects with Anti-Drug Antibodies
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Number of Multiple Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS
Hide Description Serum samples collected 4 weeks, 28 weeks and 32 weeks after VRC07-523LS administration
Time Frame Weeks 4, 28 and 32 after the first product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received multiple doses of VRC07-523LS via SC or IV administration. One subject in Group 7 who only received a single dose was not included in this analysis but was analyzed with Group 4 (single dose at 20 mg/kg IV).
Arm/Group Title Group 6: 5 mg/kg SC Multiple Doses Group 7: 20 mg/kg IV Multiple Doses
Hide Arm/Group Description:

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4: Subjects with Anti-Drug Antibodies
0
   0.0%
0
   0.0%
Week 28: Subjects with Anti-Drug Antibodies
0
   0.0%
0
   0.0%
Week 32: Subjects with Anti-Drug Antibodies
0
   0.0%
0
   0.0%
Time Frame Solicited adverse events (AEs) included systemic AEs reported by subjects at the worst severity through 3 days post any product administration; and local administration site AEs reported for subjects at the worst severity through 7 days post any product administration. Unsolicited AEs were reported from the date of product administration through 56 days thereafter, and new chronic medical conditions and SAEs with onset any time following the date of last product administration through 24 weeks.
Adverse Event Reporting Description Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
 
Arm/Group Title Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 7: 20 mg/kg IV Multiple Doses Group 3: 5 mg/kg SC Single Dose Group 6: 5 mg/kg SC Multiple Doses
Hide Arm/Group Description

Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.

VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

All-Cause Mortality
Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 7: 20 mg/kg IV Multiple Doses Group 3: 5 mg/kg SC Single Dose Group 6: 5 mg/kg SC Multiple Doses
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/5 (0.00%)   0/3 (0.00%)   0/5 (0.00%) 
Hide Serious Adverse Events
Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 7: 20 mg/kg IV Multiple Doses Group 3: 5 mg/kg SC Single Dose Group 6: 5 mg/kg SC Multiple Doses
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/5 (0.00%)   0/3 (0.00%)   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: 1 mg/kg IV Single Dose Group 2: 5 mg/kg IV Single Dose Group 4: 20 mg/kg IV Single Dose Group 5: 40 mg/kg IV Single Dose Group 7: 20 mg/kg IV Multiple Doses Group 3: 5 mg/kg SC Single Dose Group 6: 5 mg/kg SC Multiple Doses
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   2/3 (66.67%)   1/3 (33.33%)   2/3 (66.67%)   5/5 (100.00%)   2/3 (66.67%)   5/5 (100.00%) 
Gastrointestinal disorders               
Abdominal pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/5 (0.00%) 
Gastritis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Haemorrhoids * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Nausea * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Nausea  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
General disorders               
Administration site pain/tenderness  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  3/5 (60.00%) 
Administration site bruise  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/5 (0.00%) 
Administration site erythema  1 [1]  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Malaise  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/5 (40.00%)  0/3 (0.00%)  3/5 (60.00%) 
Chills  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  1/5 (20.00%) 
Pyrexia  1 [2]  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hepatobiliary disorders               
Drug-induced liver injury * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/5 (0.00%) 
Infections and infestations               
Pharyngitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/5 (0.00%) 
Upper respiratory tract infection * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%)  0/3 (0.00%)  3/5 (60.00%) 
Viral infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications               
Arthropod sting * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/5 (0.00%) 
Infusion related reaction * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  0/5 (0.00%) 
Muscle strain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%)  0/3 (0.00%)  0/5 (0.00%) 
Skin abrasion * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Investigations               
Blood creatinine increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hepatic enzyme increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Metabolism and nutrition disorders               
Hyperglycaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Hypernatraemia * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/5 (60.00%)  0/3 (0.00%)  2/5 (40.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Femoroacetabular impingement * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/5 (0.00%) 
Myalgia  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  2/5 (40.00%) 
Arthralgia  1 [3]  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  2/5 (40.00%) 
Nervous system disorders               
Dizziness * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Paraesthesia * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Headache  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  3/5 (60.00%) 
Renal and urinary disorders               
Dysuria * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Proteinuria * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Reproductive system and breast disorders               
Breast tenderness * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Vascular disorders               
Hypertension * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/5 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
[1]
Redness
[2]
Temperature (Fever)
[3]
Joint Pain
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Martin Gaudinski, MD
Organization: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301-451-8715
EMail: martin.gaudinski@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT03015181    
Other Study ID Numbers: 170030
17-I-0030 ( Other Identifier: NIH )
First Submitted: January 6, 2017
First Posted: January 9, 2017
Results First Submitted: June 3, 2019
Results First Posted: July 11, 2019
Last Update Posted: October 26, 2020