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Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa

NCT02968849 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 5404

Last updated 2026-05-04

Study results available
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Summary

This study will evaluate the preventive vaccine efficacy, safety, and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults over 24 months and potentially up to 36 months from enrollment.

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 anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a dose \> 10\^6 cell culture infectious dose 50% (CCIDv50) and \< 1 × 10\^8 CCIDv50 (nominal dose of 10\^7 CCIDv50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%) delivered IM

BIOLOGICAL

Bivalent Subtype C gp120/MF59

Subtype C TV1.C gp120 Env and 1086.C gp120 Env proteins, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion) and delivered IM

BIOLOGICAL

Placebo

Sodium Chloride for injection, 0.9% delivered IM

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Glenda Gray, MD · Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-10-26
Primary Completion
2021-11-16
Completion
2021-11-16
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Entities

Drugs
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 NCT02968849 on ClinicalTrials.gov