BioNTech SE
This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and how it affects the amount of virus in the body.
Currently, this study consists of one part (Part A) which will be a Phase I, randomized, placebo-controlled, double-blind, first-in-human (FIH), dose escalation with an initial proof-of-principle component. Depending on the safety and immunogenicity data generated in this study, the Phase II part of this study and/or some of the cohorts may not be initiated or may be terminated earlier by sponsor decision. In this study: * Three cohorts of people living without HIV (PLWOH) will be randomized in a 5:1 ratio to receive BNT168 or placebo. Participants in these cohorts will receive 3 injections.…
Key Inclusion Criteria: * Are 18 to 50 years of age inclusive at the time of giving informed consent. * For PLWOH: Individuals who are HIV-1 and HIV-2 negative at Visit 0. For PLWH: Individuals who are HIV-1 positive and HIV-2 negative at Visit 0. * Have not received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study. * Are overall healthy as defined in the protocol. * Individuals who have screening hematology and/or blood chemistry laboratory values as defined in the protocol. * For PLWOH, starting at Visit 0 and continuously until the last planned visit in thi…
Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections
Isotonic sodium chloride (NaCl) solution (0.9%). Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections
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