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.
Are HIV-1 and HIV-2 negative at Visit 0.
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;
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.
Are receiving ongoing therapy for Mycobacterium tuberculosis infection.
Sequential
BNT351
DrugIV infusion
Placebo
DrugIV infusion
BNT351
DrugSC injection
Placebo
DrugSC injection
6
Treatment groupsSee each treatment group below.
Parts A and B - Occurrence of at least one adverse event (AE)
Per part, by cohort/dose
Parts A and B - Occurrence of at least one serious AE (SAE)
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)
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
Per part, by cohort/dose
Parts A and B - Occurrence of at least one serious adverse event (SAE)
Parts A and B - Assessment of area under the concentration-time curve of BNT351, from pre-dose to last quantifiable timepoint (AUClast)
Parts A and B - Incidence of detectable BNT351 anti-drug antibodies in serum
Per part, by cohort/dose
Part B - Magnitude of cluster of differentiation 4 positive (CD4+) T cell counts
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