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Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine

NCT03284710 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-04

Study results available
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Summary

The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

ALVAC-HIV (vCP2438)

Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane (TM) anchor sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain); formulated as a lyophilized vaccine for injection at a viral titer ≥ 1 × 10\^6 cell culture infectious dose (CCID)50 and \< 1 × 10\^8 CCID50 (nominal dose of 10\^7 CCID50) and reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose

BIOLOGICAL

Bivalent Subtype C gp120/MF59

Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion); delivered as a 0.5 mL IM injection

BIOLOGICAL

Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension

Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, admixed with Aluminum Hydroxide Suspension (\~625 mcg aluminum content); delivered as a 0.5 mL IM injection

BIOLOGICAL

Bivalent Subtype C gp120

Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with sodium chloride for injection, 0.9%; delivered as a 0.5 mL IM injection

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Paul Goepfert · University of Alabama at Birmingham

  • Kathy Mngadi · Centre for the AIDS Programme of Research in South Africa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2019-12-12
Completion
2019-12-12
FDA Drug
Yes

Countries

  • Mozambique
  • South Africa
  • Zimbabwe

Study Locations

More Related Trials

Entities

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 NCT03284710 on ClinicalTrials.gov