Actively Recruiting
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
Led by BioNTech SE · Updated on 2026-03-19
61
Participants Needed
3
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Part A: HIV-1 and HIV-2 negative at screening
- For Part A: Assessed as low risk for acquiring HIV and committed to avoiding high-risk behaviors until study end
- For Part A: Agree to discuss HIV risks and receive HIV risk reduction counseling
- For Part B: HIV-1 positive and HIV-2 negative at screening
- For Part B: cART-nafve or discontinued cART within 12 months prior to screening (up to 18 months with approval)
- For Part B: If cART-experienced, stopped cART at least 4 weeks before screening
- For Part B: Never received lenacapavir or other long-acting antiretroviral therapies in last 6 months
- For Part B: CD4+ T cell count 8400 cells/�b5L and plasma HIV-1 RNA levels between 1,000-100,000 copies/mL at screening
- For Part B: Willing to start cART at protocol-defined time
- For Part B: Willing to undergo HIV transmission risk counseling and maintain low-risk behavior
You will not qualify if you...
- For Part A: Previous HIV vaccination or broadly neutralizing antibody in another study
- For Part A: Known or suspected immune impairment or immunodeficiency, or recent immunosuppressive therapy within 60 days (except certain corticosteroids)
- For Part A: History of allergic reactions to humanized antibodies or BNT351 components
- For Part B: Previous HIV vaccination or broadly neutralizing antibody in another study
- For Part B: Currently receiving treatment for tuberculosis
- For Part B: History of AIDS-defining illnesses or opportunistic infections
- For Part B: History of multi-class drug resistant HIV-1 infection
- For Part B: History of malignancy within 5 years, except certain skin or cervical cancers
- For Part B: Known or suspected immune impairment or immunodeficiency (except HIV), or recent immunosuppressive therapy within 60 days (except certain corticosteroids)
- For Part B: History of allergic reactions to humanized antibodies or BNT351 components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Johns Hopkins
Baltimore, Maryland, United States, 21205-1832
Actively Recruiting
2
UK Köln
Cologne, Germany, 50937
Not Yet Recruiting
3
CRS Mannheim
Mannheim, Germany, 68167
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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