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Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults

NCT03220724 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2026-05-04

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

CH505TF

Administered by intramuscular (IM) injection in the thigh

BIOLOGICAL

CH505w53

Administered by IM injection in the thigh

BIOLOGICAL

CH505w78

Administered by IM injection in the thigh

BIOLOGICAL

CH505 M5

Administered by IM injection in the thigh

BIOLOGICAL

GLA-SE adjuvant

Admixed with all CH505 gp120 proteins

BIOLOGICAL

Placebo

Administered by IM injection in the thigh

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Magda Sobieszczyk · Columbia University

  • James Kobie · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2023-03-21
Completion
2023-03-21
FDA Drug
Yes

Countries

  • United States

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 NCT03220724 on ClinicalTrials.gov