RecruitingPhase 2NCT06812494

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

200 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

HIV

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing three broadly neutralizing antibodies (called VRC07-523LS, PGT121.414.LS, and PGDM1400LS) in healthy adults who do not have HIV. Broadly neutralizing antibodies are proteins that can block many different strains of HIV from entering cells. This is an early safety study to see if these antibodies are safe and how the body processes them. **You may be eligible if...** - You are between 18 and 65 years old - You do not have HIV - You are considered low risk for HIV and are willing to avoid high-risk behaviors during the study - Your blood counts (hemoglobin, white blood cells) meet the minimum thresholds - You are willing to receive HIV test results and discuss HIV prevention **You may NOT be eligible if...** - You are currently in another clinical trial - You have immune system conditions or take medications affecting immune function - You are pregnant or breastfeeding - You are considered high risk for HIV acquisition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVRC07-523LS 400mg

Intravenous infusion (IV)

BIOLOGICALPGT121.414.LS 400mg

IV infusion

BIOLOGICALPGDM1400LS 400mg

IV infusion

BIOLOGICALVRC07-523LS 3200mg

IV infusion

BIOLOGICALPGT121.414.LS 1600mg

IV infusion

BIOLOGICALPGDM1400LS 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

View Full Details on ClinicalTrials.gov

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