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A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

A Randomized, Double Blind, Controlled, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

NCT06812494•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an estimated total duration of participation of eighteen (18) months.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants need to be between 18 and 65 years old.
•Participants must have access to a participating clinical research site and be willing to follow the study schedule.
•Participants should understand the study details and be willing to give informed consent.
•Participants must agree not to join any other clinical trials until they finish this study.
•Participants must be willing to receive HIV test results.
•Participants should be open to discussing HIV prevention.
•Clinic staff should assess participants as having a low risk of getting HIV, and participants must commit to avoiding high-risk behaviors during the study.
•Hemoglobin: Participant meets minimum levels depending on gender and hormone therapy status.
•White Blood Cells (WBC): Should be within the normal range or approved by a site clinician.
•Platelets: At least 100,000 cells/mm³.
+11 more criteria

Exclusion Criteria

•Participants cannot have had a blood transfusion within the last 120 days.
•Participants cannot have received experimental treatments within the last 30 days.
•Participants cannot weigh less than 35 kg (about 77 lbs).
•Participants cannot plan to join another clinical trial during this study.
•Participants cannot be pregnant or breastfeeding.
•Participants cannot have received an HIV vaccine in a previous trial (unless it was a placebo, subject to Protocol Safety Review Team's approval).
•Participants cannot have had any live vaccines within the last 14 days or non-live vaccines within the last 7 days.
•Participants cannot have had humanized or human monoclonal antibodies recently, except for certain HIV antibodies more than 12 months ago.
•Participants cannot have had allergy shots within the last 14 days.
•Participants cannot have taken immunosuppressive drugs within the last 30 days, with some exceptions like nasal sprays or mild skin treatments.
+15 more criteria

Locations (21)

Alabama CRA (Site #31788)

Birmingham, Alabama, United States

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, United States

The Hope Clinic of the Emory Vaccine Research Center; Emory University

Decatur, Georgia, United States

Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

Boston, Massachusetts, United States

Fenway Health

Boston, Massachusetts, United States

BIDMC VCRS (Site ID# 32077)

Boston, Massachusetts, United States

Columbia P&S CRS

New York, New York, United States

University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467)

Rochester, New York, United States

Chapel Hill CRS (Site #3201)

Chapel Hill, North Carolina, United States

Penn Prevention CRS

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 7, 2025

Primary Completion Date

January 15, 2027

Completion Date

September 15, 2027

Last Updated

December 23, 2025

Enrollment

200

ESTIMATED participants

Conditions

HIV

Interventions

VRC07-523LS 400mg

BIOLOGICAL

PGT121.414.LS 400mg

BIOLOGICAL

PGDM1400LS 400mg

BIOLOGICAL

VRC07-523LS 3200mg

BIOLOGICAL

PGT121.414.LS 1600mg

BIOLOGICAL

PGDM1400LS 1600mg

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

Inclusion Criteria

Exclusion Criteria

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