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Showing 1–13 of 13 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: VRC01 Monoclonal Antibody Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults

NCT01993706
View directory record Official record
Conditions
HIV Infection, Monoclonal Antibody, Human, HIV Antibodies, VRC01 Monoclonal Antibody, Neutralizing Antibody
Interventions
VRC-HIVMAB060-00-AB
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years
Enrollment
29 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2015
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Dec 16, 2019 · Synced Jul 22, 2026, 11:08 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults

NCT02797171
View directory record Official record
Conditions
HIV Infections
Interventions
VRC01, VRC01LS
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years
Enrollment
80 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2019
U.S. locations
3
States / cities
Cleveland, Ohio • Philadelphia, Pennsylvania • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Mar 19, 2024 · Synced Jul 22, 2026, 11:08 PM EDT
Completed Phase 1 Interventional Results available

Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)

NCT02411539
View directory record Official record
Conditions
HIV Infections
Interventions
VRC01, Placebo
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 65 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
13
States / cities
San Diego, California • Aurora, Colorado • Chicago, Illinois + 10 more
Source: ClinicalTrials.gov public record
Updated Nov 4, 2021 · Synced Jul 22, 2026, 11:08 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to Healthy Adults

NCT02599896
View directory record Official record
Conditions
Prevention of HIV Infection, HIV Antibodies, Monoclonal Antibody, Human, Neutralizing Antibody
Interventions
VRC-HIVMAB080-00-AB (VRC01LS), VRC-HIVMAB060-00-AB (VRC01)
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years
Enrollment
49 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2018
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Dec 16, 2019 · Synced Jul 22, 2026, 11:08 PM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)

NCT03729752
View directory record Official record
Conditions
HIV-1-infection
Interventions
[89]Zr-DFO-VRC-HIVMAB060-00-AB
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2026
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Jun 4, 2025 · Synced Jul 22, 2026, 11:08 PM EDT
Completed Phase 1 Interventional Results available

Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

NCT02256631
View directory record Official record
Conditions
HIV Infections
Interventions
VRC01, VRC01LS, VRC07-523LS
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
0 Days to 5 Days
Enrollment
83 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2021
U.S. locations
10
States / cities
Los Angeles, California • Aurora, Colorado • Fort Lauderdale, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Feb 7, 2023 · Synced Jul 22, 2026, 11:08 PM EDT
Completed Phase 1 Interventional Results available

VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption

NCT02471326
View directory record Official record
Conditions
HIV
Interventions
VRC-HIVMAB060-00-AB (VRC01)
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 65 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 30, 2017 · Synced Jul 22, 2026, 11:08 PM EDT
Completed Phase 1 Interventional Results available

Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption

NCT02463227
View directory record Official record
Conditions
HIV Infections
Interventions
VRC01
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years and older
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
2
States / cities
Birmingham, Alabama • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 18, 2021 · Synced Jul 22, 2026, 11:08 PM EDT
Terminated Phase 1 Interventional Results available

Combination Therapy With VRC01 and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions

NCT03831945
View directory record Official record
Conditions
HIV
Interventions
VRC-HIVMAB060-00-AB (VRC01), 10-1074, Normal Saline Placebo
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 65 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 11, 2021 · Synced Jul 22, 2026, 11:08 PM EDT
Completed Phase 1 Interventional

VRC 601: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to HIV-Infected...

NCT01950325
View directory record Official record
Conditions
HIV-1 Infection, Neutralizing Antibody, Monoclonal Antibody, Viral Load, HIV Antibodies
Interventions
VRC-HIVMAB060-00-AB
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 70 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Dec 16, 2019 · Synced Jul 22, 2026, 11:08 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men

NCT02716675
View directory record Official record
Conditions
HIV Infections
Interventions
VRC01, Placebo for VRC01
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years · Male only
Enrollment
2,699 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2020
U.S. locations
19
States / cities
Birmingham, Alabama • Los Angeles, California • San Francisco, California + 13 more
Source: ClinicalTrials.gov public record
Updated Feb 22, 2022 · Synced Jul 22, 2026, 11:08 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Safety Study of Monoclonal Antibodies to Reduce the Vaginal Transmission of HSV and HIV

NCT02579083
View directory record Official record
Conditions
HIV, Herpes Simplex Infections
Interventions
MB66, Placebo Film
Drug
Lead sponsor
KBio Inc
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
38 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2018
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Nov 13, 2023 · Synced Jul 22, 2026, 11:08 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Evaluating the Safety and Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults

NCT02165267
View directory record Official record
Conditions
HIV Infections
Interventions
VRC01, SC placebo for VRC01, IV placebo for VRC01
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years
Enrollment
88 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2016
U.S. locations
6
States / cities
Boston, Massachusetts • New York, New York • Cleveland, Ohio + 1 more
Source: ClinicalTrials.gov public record
Updated Oct 14, 2021 · Synced Jul 22, 2026, 11:08 PM EDT