A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Notable Primary endpoints: details revised at 2 of 5 entries Show 4 more changesShow less
    • Trial sites expanded: 1 → 4 locations
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 11 of 11 entries
    • Study description expanded, about 2 words
  2. Notable Recruitment opened
    • Study sites: 0 to 1
    • Primary and study completion dates: Jan 2028 to Feb 2028
    • Start date changed from estimate of Jul 2026 to Aug 4, 2026
    v2
  3. Minor Study First Submitted
  • 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.
49 trials monitored
See 3 trials at risk
This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and how it affects the amount of virus in the body.
Trial Details
NCT Number NCT07698600
Lead Sponsor BioNTech SE
Conditions
(from sponsor)
HIV -1 Infection
Related terms Acquired Immunodeficiency Syndrome
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov