NCT07392372 · BioNTech SE
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
What this study 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.
View original scientific description
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.
Interventions
DRUG
BNT351
IV infusion
DRUG
Placebo
IV infusion
DRUG
BNT351
SC injection
DRUG
Placebo
SC injection
Primary outcome measures
Parts A and B - Occurrence of at least one adverse event (AE)
Time frame: From dosing to 56 days post-dose
Per part, by cohort/dose
Parts A and B - Occurrence of at least one serious AE (SAE)
Time frame: From dosing to 56 days post-dose
Per part, by cohort/dose
Parts A and B (except for Cohort A1) - Occurrence of infusion-related reactions (IRRs) Grade ≥2 (graded based on National Cancer Institute Common Terminology Criteria for AEs [NCI CTCAE] version 5.0 as specified in the protocol)
Time frame: From the start of IV dosing through 72 hours after the start of IV dosing
Per part, by cohort/dose
Parts A and B - Occurrence of at least one solicited local reaction (pain/tenderness, erythema/redness, induration/swelling) at the investigational medicinal product administration site
Time frame: From dosing through 7 days post-dose
Per part, by cohort/dose
Parts A and B- Occurrence of at least one solicited systemic event (vomiting, diarrhea, headache, fatigue/malaise, myalgia/arthralgia, fever)
Time frame: From dosing through 7 days post-dose
Per part, by cohort/dose
Parts A and B - Assessment of maximum concentration of BNT351
Time frame: From dosing through 7 days post-dose
Per part, by cohort/dose
Part B - Occurrence of any acquired immunodeficiency syndrome (AIDS)-defining illness or opportunistic infection as defined in the protocol
Time frame: From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
Part B - Occurrence of absolute CD4+ T cell count <350 cells/µL or CD4+ T cell count <15% of total lymphocyte count
Time frame: From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
Part B - Change from baseline in HIV log10 plasma viral load prior to cART initiation
Time frame: At 7, 14, 21, 28, 35, 42, 49, and 56 days post-dose
Part B - Maximum decrease from baseline in HIV log10 plasma viral load prior to cART initiation
Time frame: From baseline up to the time of cART initiation (up to a maximum of 56 days post-dose)
Part B - Time from dosing to lowest viral load prior to cART initiation
Time frame: From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
Part B - Time from dosing to viral rebound defined as HIV-1 RNA viral load increase >0.75 log10 copies/mL from nadir (i.e., lowest HIV-1 RNA viral load from 7 days post-dose (Visit 3) and through pre-cART initiation)
Time frame: From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Are HIV-1 and HIV-2 negative at Visit 0.
- Starting at Visit 0 and continuously until the last planned visit in this study are individuals who:
- Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.
- Agree to discuss HIV disease risks;
- Agree to HIV acquisition risk reduction counseling; Part B:
- Are HIV-1 positive and HIV-2 negative at Visit 0.
- Individuals who at Visit 0:
- Are cART-naïve individuals who were diagnosed with HIV-1 infection ≤12 months prior to screening, OR are individuals who have discontinued cART and who were diagnosed with HIV-1 infection ≤12 months prior to screening or ≤18 months if this is found to be acceptable after discussion on a case-by-case basis with the sponsor's medical monitor.
- If cART-experienced, have discontinued cART for at least 4 weeks before screening (if the individual was taking long-acting antiretroviral therapy \[ART\]), see the following bullet). For individuals who have discontinued cART: Are able to comply with study procedures and assessments in the investigator's judgment.
- Have never received lenacapavir or ibalizumab or fostemsavir, and have not received other long-acting ARTs in the last 6 months (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).
- Have a CD4+ T cell count of ≥500 cells/µL and plasma HIV-1 RNA levels between 5,000-100,000 copies/mL at screening.
- Are willing to initiate cART at a protocol-defined timepoint (56 days post-dose, or earlier if meeting early cART start criteria or at investigator's discretion).
- Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners. Key
Exclusion criteria
- Parts A and B:
- Have received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.
- Have a known or suspected impairment/alteration of immune function or immunodeficiency (except for HIV infection, applicable to Part B only), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, blood product, or oral or parenteral steroid within 60 days prior to Day 1 or planned administration during the study. The following exception applies: Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is allowed.
- Have a history of generalized urticaria or angioedema, or of allergy, anaphylaxis, hypersensitivity or intolerance to a human or humanized antibody or to BNT351 excipients. Part B only:
- Are receiving ongoing therapy for Mycobacterium tuberculosis infection.
- Have a history of opportunistic infections/AIDS-defining illnesses as defined in the protocol.
- Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.
- Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness (as defined in the protocol) is exclusionary regardless of the perceived risk of recurrence. NOTE: Other protocol defined inclusion/exclusion criteria apply.
Where
- Chicago, Illinois
- Baltimore, Maryland
- St Louis, Missouri
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations