A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV (NCT06812494)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Alabama CRA (Site #31788) — Birmingham, Alabama
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- Alabama CRA (Site #31788) — Birmingham, Alabama
- Bridge HIV, San Francisco Department of Public Health — San Francisco, California
- The Hope Clinic of the Emory Vaccine Research Center; Emory University — Decatur, Georgia
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts
- Fenway Health — Boston, Massachusetts
- BIDMC VCRS (Site ID# 32077) — Boston, Massachusetts
- Columbia P&S CRS — New York, New York
- University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467) — Rochester, New York
- Chapel Hill CRS (Site #3201) — Chapel Hill, North Carolina
- Penn Prevention CRS — Philadelphia, Pennsylvania
- University of Pittsburgh CRS (Site 1001) — Pittsburgh, Pennsylvania
- Vanderbilt Vaccine (VV) CRS — Nashville, Tennessee
- Seattle Vaccine and Prevention CRS (Site ID# 30331) — Seattle, Washington
- Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS — Rio de Janeiro, Rio de Janeiro
- Via Libre (Site ID 31909) — Lima, Lima Province
- CITBM CRS (Site ID 31970) — Callao, Provincia Constitucional del Callao
- San Miguel CRS (Site #11302) — Lima,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.