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

Part of paid clinical trials in Houston, Texas.

Sponsor
BioNTech SE
Study ID
NCT07698600
Phase
PHASE1
Status
Recruiting
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Conditions

  • HIV -1 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • BNT168 — BIOLOGICAL
    Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections
  • Placebo — OTHER
    Isotonic sodium chloride (NaCl) solution (0.9%). Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Aug 4, 2026
Status verified
Aug 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: A1 in PLWOH - BNT168 dose level 1
  • Experimental: A2 in PLWOH - BNT168 dose level 2
  • Experimental: A3 in PLWOH - BNT168 dose level 3
  • Experimental: A4 in PLWH - BNT168 dose level 2
    This cohort will undergo ATI post vaccination
  • Experimental: A5 in PLWH - BNT168 dose level 3
    This cohort will undergo ATI post vaccination
  • Placebo Comparator: PLWOH - Placebo
  • Placebo Comparator: PLWH - Placebo
    PLWH participants receiving placebo will also undergo ATI post vaccination

Primary Outcome Measure

Occurrence of at least one adverse event [ Time Frame: From dosing through 28 days after each IMP dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Crofoot Research CenterHoustonTexas77098-

Find similar trials in Houston, TX

By research site
The Crofoot Research Center· Houston, TX

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