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NCT06812494 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Recruiting
Registry status
Phase 2
Development phase
200
Enrollment target
20
Study locations

NCT06812494 is a Phase 2 study of HIV that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 200 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT06812494, a Phase 2 study of HIV, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

RECRUITING
Registry status
Phase 2
Development phase
200 participants
Enrollment target
20
Study locations

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

HIV

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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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, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 439-participant average among 303 other HIV trials with a reported enrollment target (54% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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.

NCT06812494 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Massachusetts, Other, New York.

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.

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).

Who is sponsoring clinical trial NCT06812494?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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.

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