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BNT168 Vaccine for HIV

Bc
Overseen ByBioNTech clinical trials patient information
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: BioNTech SE

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

BR

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

This trial is for adults aged 18–50, both with and without HIV. People with HIV must be on stable treatment for at least a year and generally healthy. Participants can't have had certain HIV treatments or vaccines before, and must agree to discuss and reduce their risk of getting HIV.

Inclusion Criteria

For PLWOH: Individuals who are HIV-1 and HIV-2 negative at Visit 0
For PLWOH, agree to discuss HIV disease risks
Agree not to donate blood from the time of first IMP administration until 90 days after the last IMP administration for PLWOH and until the End of Study Visit for PLWH
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Exclusion Criteria

Have history of serious adverse reactions including anaphylaxis, respiratory distress, angioedema, or urticaria to vaccines or vaccine components such as lipids
Have an abnormal electrocardiogram at Visit 0 as specified in the protocol
Have Grade ≥2 hypertension per FDA toxicity grading scale at screening
See 15 more

What Are the Treatments Tested in This Trial?

Interventions

  • BNT168

Trial Overview

The study is testing the safety and immune response of an experimental RNA-based vaccine called BNT168 compared to a placebo in adults living with or without HIV. Participants are randomly assigned to receive either the vaccine or placebo.

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Placebo Group

Group I: A5 in PLWH - BNT168 dose level 3Experimental Treatment1 Intervention
Group II: A4 in PLWH - BNT168 dose level 2Experimental Treatment1 Intervention
Group III: A3 in PLWOH - BNT168 dose level 3Experimental Treatment1 Intervention
Group IV: A2 in PLWOH - BNT168 dose level 2Experimental Treatment1 Intervention
Group V: A1 in PLWOH - BNT168 dose level 1Experimental Treatment1 Intervention
Group VI: PLWOH - PlaceboPlacebo Group1 Intervention
Group VII: PLWH - PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials
84
Recruited
120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

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