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

NCT06812494 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-07

No results posted yet for this 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

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Department of Health and Human Services

    collaborator FED

  • Dale and Betty Bumpers Vaccine Research Center (VRC)

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-07
Primary Completion
2027-01-15
Completion
2027-09-15
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Peru
  • South Africa

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06812494 on ClinicalTrials.gov