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Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Chimp Adenovirus Vaccines Expressing Clade C gp140 & CH505TF gp120 Protein Boost in HIV-uninfected Adult.

NCT05182125 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-12-24

Study results available
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Summary

The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 vaccines based on chimpanzee serotypes of adenovirus expressing clade C gp140 and a CH505TF gp120 protein boost in healthy, HIV- uninfected adult participants.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

AdC6-HIVgp140

The product is diluted in 2.5% Glycerol/25 mM NaCl/20 mM TRIS \[tris(hydroxymethyl)aminomethane\], pH 8.0 formulation buffer to a concentration of 1.2 x 10\^11 vp/mL and filled at 0.3 mL for AdC6-HIVgp140 into a 2 mL Type 1 glass vial and stoppered with a gray chlorobutyl rubber stopper. The product is clear to slightly cloudy liquid, essentially free of visible particles. AdC6-HIVgp140 should be stored at ≤ -65°C prior to use/preparation. The study product is described in further detail in the Investigator's Brochure (IB).

BIOLOGICAL

AdC7-HIVgp140

The products is diluted in 2.5% Glycerol/25 mM NaCl/20 mM TRIS \[tris(hydroxymethyl)aminomethane\], pH 8.0 formulation buffer to a concentration of 1.2 x 10\^11 vp/mL and filled at 0.6 mL for AdC7-HIVgp140 into a 2 mL Type 1 glass vial and stoppered with a gray chlorobutyl rubber stopper. The product is clear to slightly cloudy liquid, essentially free of visible particles. AdC7-HIVgp140 should be stored at ≤ -65°C prior to use/preparation. The study product is described in further detail in the IB.

BIOLOGICAL

CH505TF gp120

CH505TF gp120 is formulated in 20 mM sodium phosphate, 150 mM NaCl, 0.02% polysorbate 80 (PS80), pH 6.5, supplied as a frozen liquid in 2 mL glass vials. Each 2 mL vial contains 0.75 mL of formulated gp120 at a concentration of 0.8 mg/mL and is stored at ≤ -65°C. The study product is described in further detail in the IB.

BIOLOGICAL

GLA-SE (glucopyranosyl lipid A - stable emulsion; [labeled as AP 10-201])

The GLA-SE adjuvant will be provided as vials containing 20 mcg/mL GLA in a 4% oil-in-water emulsion. Each sterile, single use vial contains 0.4 mL of product. Product appears as a milky-white liquid. GLA-SE must be stored at 2° to 8°C and must not be frozen. The study product is described in further detail within the IB.

BIOLOGICAL

Placebo

Placebo will be Sodium Chloride for Injection, 0.9%, will be used as the placebo. It must be stored as recommended by the manufacturer.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Department of Health and Human Services

    collaborator FED

  • HIV Vaccine Trials Network

    lead NETWORK

Principal Investigators

  • Ameena Goga · HIV Prevention Research Unit, South African Medical Research Council

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
2021-11-25
Primary Completion
2023-08-21
Completion
2025-05-14
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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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 NCT05182125 on ClinicalTrials.gov