BNT351 for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new antibody treatment called BNT351 for individuals with and without HIV. For those without HIV, the study examines any side effects and measures BNT351 levels in the blood. For participants with HIV, it assesses how well BNT351 controls the virus in the blood. Suitable candidates include individuals living with HIV who haven't recently received antiretroviral treatment, or those without HIV who are at low risk of acquiring it. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Is there any evidence suggesting that BNT351 is likely to be safe for humans?
Research shows that BNT351 is being tested for safety and effectiveness in people with and without HIV. As this is the first human trial of BNT351, no previous safety data exists. However, researchers closely monitor early trials to detect any side effects.
These early trials primarily focus on safety. They aim to determine if the treatment is well-tolerated and only commence if some evidence suggests potential safety. Researchers will carefully observe participants for negative reactions and gather information on how the body processes the treatment.
For those considering participation, the main goal is to ensure BNT351's safety and assess its impact on virus levels in the blood.12345Why do researchers think this study treatment might be promising?
Most treatments for HIV focus on suppressing the virus with antiretroviral therapy (ART), which requires daily medication to keep the virus in check. But BNT351 works differently, targeting the immune system to potentially enhance the body's ability to control HIV without the need for continuous ART. Researchers are excited about BNT351 because it might offer a new approach by boosting the immune response and possibly reducing the reliance on lifelong medication. This innovative mechanism could be a game-changer, offering hope for better long-term management of HIV.
What evidence suggests that BNT351 might be an effective treatment for HIV?
Research has shown that BNT351, a type of antibody, targets key components of the HIV-1 virus, helping to inhibit its function. Studies found that BNT351 neutralized 119 different strains of HIV from various groups, which are akin to families of the virus. This suggests that BNT351 might be effective against many kinds of HIV. In this trial, participants will receive BNT351 at different dose levels, while some will receive a placebo for comparison. Additionally, antibodies like BNT351 can enhance the body's immune response to HIV, but the extent of their impact on controlling the virus or improving health outcomes remains unclear.45678
Who Is on the Research Team?
BioNTech Response Person
Principal Investigator
BioNTech SE
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of BNT351 or placebo (Part A) or BNT351 (Part B)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Observation (Part B)
Participants in Part B undergo an 8-week observation period with HIV viral load assessments before starting cART
What Are the Treatments Tested in This Trial?
Interventions
- BNT351
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
PLWH will receive BNT351 at a protocol-defined dose level. cART will start 56 days post-BNT351 dosing or earlier.
PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (2:1)
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioNTech SE
Lead Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University
Citations
1.
allsci.com
allsci.com/news/biontech-initiates-first-in-human-phase-i-trial-for-hiv-antibody-bnt351/BioNTech initiates first-in-human Phase I Trial for HIV ...
BNT351 is a broadly neutralizing antibody designed to target conserved regions of the HIV-1 envelope glycoprotein, aiming to neutralize a wide ...
BNT-351, long-acting bNAb with potent HIV neutralization
The antibody effectively neutralized a broad panel of 119 HIV strains spanning multiple clades and showed strong activity against the clade- ...
Clinical trials of broadly neutralizing monoclonal antibodies in ...
This review evaluates the clinical outcomes and potential of bNAbs in people living with HIV, summarizing findings from a review of 154 registered trials.
Research Toward a Cure Trials
A listing of clinical trials and observational studies related to the research effort to cure HIV infection, mainly derived from the clinicaltrials.gov online ...
NCT01071031 | HIV Vaccine Study in HIV Positive Patients
The purpose of the study is to see whether a single vaccination (injection) with the investigational HIV vaccine is safe and effective in patients who are ...
A Clinical Trial Investigating the Safety and Biological Activity of ...
Overview. This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV).
Clinical Trials in the European Union - EMA
A clinical trial investigating the safety and biological activity of the antibody BNT351 in adults living without and with HIV.
8.
investors.biontech.de
investors.biontech.de/system/files-encrypted/nasdaq_kms/assets/2026/03/10/7-10-22/BNTX%204QFY%202025%20Presentation_v1.pdfQ2 2025 BNTX Presentation - BioNTech
... safety data; the nature of the clinical data, which is subject ... Human immunodeficiency virus. PROC. Platinum-resistant ovarian cancer.
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