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Evaluating Safety and Immune Response to the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants

NCT04607408 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-01-29

Study results available
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Summary

This study evaluated the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

CH505TF gp120

HIV-1 CH505 transmitted/founder virus Env gp120 immunogen

BIOLOGICAL

GLA-SE adjuvant

An oil-in-water stable emulsion (SE) containing the immunological adjuvant Glucopyranosyl Lipid A (GLA)

BIOLOGICAL

Placebo

Sodium Chloride for Injection, 0.9% USP

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • HIV Vaccine Trials Network

    lead NETWORK

Principal Investigators

  • Avy Violari · Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

  • Georgia Tomaras · Duke University, HVTN Laboratory

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
0 Days
Max Age
5 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2024-07-24
Completion
2024-07-24
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs

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 NCT04607408 on ClinicalTrials.gov