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Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall Good Health in South Africa.

Study acronym: IAVI G004
StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v8
  2. Site details revised at 1 of 6 sitesv7
  3. Site details revised at 2 of 6 sitesv6
  4. Primary completion date: Oct 30, 2026 to Dec 8, 2026
    • Start date changed from estimate of Dec 17, 2025 to Dec 15, 2025
    • Study sites revised (6)
    • Collaborators reordered
    v5
  5. Site contacts updated at 1 of 6 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Lead sponsor: HIV Vaccine Trials Network to International AIDS Vaccine Initiativev3 Show 10 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Dec 19, 2025 to Oct 30, 2026
    • Start date: Sep 9, 2025 to Dec 17, 2025
    • Primary endpoints: 9 to 2
    • Study sites: 8 to 6
    • Study completion date: Dec 19, 2025 to Mar 31, 2027
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 2 to 1
    • Collaborators: 7 to 4
    • Study title shortened, about 6 words
  2. Start date: Feb 19, 2025 to Sep 9, 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to evaluate the safety and immunogenicity of mRNAs encoding HIV immunogens (eOD-GT8 60mer, core-g28v2 60mer, N332-GT5 gp151) in adult participants without HIV and in overall good health in South Africa.
Trial Details
NCT Number NCT06694753
Lead Sponsor International AIDS Vaccine Initiative
Collaborators: ModernaTX, Inc., The Scripps Research Institute, National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation
Conditions
(from sponsor)		 HIV Infections
Related terms HIV Infections
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov