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RECRUITING
NCT06812494
PHASE2

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-03-07

Completion Date

2027-09-15

Last Updated

2026-04-07

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

VRC07-523LS 400mg

Intravenous infusion (IV)

BIOLOGICAL

PGT121.414.LS 400mg

IV infusion

BIOLOGICAL

PGDM1400LS 400mg

IV infusion

BIOLOGICAL

VRC07-523LS 3200mg

IV infusion

BIOLOGICAL

PGT121.414.LS 1600mg

IV infusion

BIOLOGICAL

PGDM1400LS 1600mg

IV infusion

Locations (22)

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

University of Pittsburgh CRS (Site 1001)

Pittsburgh, Pennsylvania, United States

Vanderbilt Vaccine (VV) CRS

Nashville, Tennessee, United States

Seattle Vaccine and Prevention CRS (Site ID# 30331)

Seattle, Washington, United States

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Rio de Janeiro, Brazil

ACSA CRS

Iquitos, Maynas, Peru

CITBM CRS (Site ID 31970)

Callao, Peru

Via Libre (Site ID 31909)

Lima, Peru

San Miguel CRS (Site #11302)

Lima, Peru

Perinatal HIV Research Unit (PHRU)

Johannesburg, Gaunteng, South Africa

Chatsworth CRS

Chatsworth, KwaZulu-Natal, South Africa

Setshaba Research Centre

Soshanguve-H, Soshanguve, South Africa

Groote Schuur HIV CRS

Cape Town, Western Cape, South Africa