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.
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.
Have had major surgery (e.g., major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before Visit 0, or will not have fully recovered from surgery, or have major surgery planned during the time the participants are expected to participate in the study.
Have an abnormal electrocardiogram at Visit 0 as specified in the protocol.
Have any existing condition which may affect IMP injection and/or assessment of local reactions, e.g., tattoos, severe scars, etc.
Have any bleeding diathesis or condition associated with prolonged bleeding that, in the opinion of the investigator, could compromise their wellbeing if they participate in the study.
Sequential
BNT168
Biological/VaccineIntramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections
Placebo
Other interventionIsotonic 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
7
Treatment groupsSee each treatment group below.
Occurrence of at least one adverse event
In PLWOH and PLWH. By cohort and pooled placebo.
Occurrence of at least one serious adverse event
In PLWOH and PLWH. By cohort and pooled placebo.
Occurrence of at least one adverse event of special interest
In PLWOH and PLWH. By cohort and pooled placebo.
Occurrence of at least one solicited local reaction (pain, erythema/redness, swelling) at the IMP injection site
In PLWOH and PLWH. By cohort and pooled placebo. From dosing through 7 days after each IMP dose.
Occurrence of cytokine positive cluster of differentiation (CD) 4+ T cells
In PLWOH and PLWH. By cohort and pooled placebo. For PLWOH, at 7 days post-Dose 2, and 7 days post-Dose 3. For PLWH, at 7 days post-Dose 2, 7 days post-Dose 3 and/or 7 days post-Dose 4. As assessed by multi-parameter intracellular cytokine staining (ICS) following stimulation with IMP-specific peptide pools.
Occurrence of cytokine positive CD8+ T cells
In PLWOH and PLWH. By cohort and pooled placebo. For PLWOH, at 7 days post-Dose 2 and 7 days post-Dose 3. For PLWH, at 7 days post-Dose 2, 7 days post-Dose 3 and/or 7 days post-Dose 4. As assessed by multi-parameter ICS following stimulation with IMP-specific peptide pools.
Occurrence of proliferating CD8+ T cell responses (measured by carboxifluorescein diacetate succinimidyl ester)
In PLWOH and PLWH. By cohort and pooled placebo. For PLWOH, at 28 days post-Dose 2 and 28 days post-Dose 3. For PLWH, at 28 days post-Dose 2, 28 days post-Dose 3 and 28 days post-Dose 4. As assessed by flow cytometry following stimulation with IMP-specific peptide pools.
Magnitude of CD4+ T cell counts from ATI start through cART restart
In PLWH. By cohort and pooled placebo.
Click on the lead sponsor to view all of their trials.
