A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorBioNTech SE

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • BNT168
  • Placebo

Treatment groups

126 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators