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RECRUITING Phase 2

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

NCT06812494 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • BIOLOGICAL VRC07-523LS 400mg
  • BIOLOGICAL PGT121.414.LS 400mg
  • BIOLOGICAL PGDM1400LS 400mg
  • BIOLOGICAL VRC07-523LS 3200mg
  • BIOLOGICAL PGT121.414.LS 1600mg

Study Locations (20)

Massachusetts

  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston
  • Fenway Health — Boston
  • BIDMC VCRS (Site ID# 32077) — Boston

Other

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS — Rio de Janeiro
  • CITBM CRS (Site ID 31970) — Callao
  • Via Libre (Site ID 31909) — Lima

New York

  • Columbia P&S CRS — New York
  • University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467) — Rochester

Pennsylvania

  • Penn Prevention CRS — Philadelphia
  • University of Pittsburgh CRS (Site 1001) — Pittsburgh

Alabama

  • Alabama CRA (Site #31788) — Birmingham

California

  • Bridge HIV, San Francisco Department of Public Health — San Francisco

Georgia

  • The Hope Clinic of the Emory Vaccine Research Center; Emory University — Decatur

North Carolina

  • Chapel Hill CRS (Site #3201) — Chapel Hill

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2025-03-07
Est. Completion 2027-09-15
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06812494

The ClinicalTrials.gov registry entry for NCT06812494 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 5 interventions — of which VRC07-523LS 400mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06812494 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Massachusetts, Other, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06812494 about?

NCT06812494 is a clinical study titled "A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV". 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 HI...

What is the current status of trial NCT06812494?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2025-03-07. Estimated completion is 2027-09-15.

What conditions does trial NCT06812494 study?

This clinical trial studies the following conditions: HIV. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06812494?

The interventions under investigation include: VRC07-523LS 400mg (BIOLOGICAL), PGT121.414.LS 400mg (BIOLOGICAL), PGDM1400LS 400mg (BIOLOGICAL), VRC07-523LS 3200mg (BIOLOGICAL), PGT121.414.LS 1600mg (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06812494?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06812494 being conducted?

This trial has 20 study locations across Alabama, California, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial