Clinical Trial

A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV). This study will also test the anti-viral activity of BNT351 in people living with HIV (PLWH) with detectable virus levels. The main goals of this study are: * To learn about the safety of BNT351 and check for side effects. * To measure the amount of BNT351 antibody in blood over time. * To test the amount of HIV in the blood at different times after treatment with BNT351 in people living with HIV.
Protocol Amendment History 4 changes
critical Primary endpoint(s) modified 2026-06-23
minor Trial arms changed: 5 -> 6 2026-06-23
notable Trial sites expanded: 3 -> 6 locations 2026-06-23
notable Primary completion moved earlier: 2027-06 -> 2026-11 2026-06-23
Trial Details
NCT Number NCT07392372
Lead Sponsor BioNTech SE
Conditions HIV -1 Infection
Enrollment 67 participants
Start Date 2026-02-09
Primary Completion 2026-11 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-12