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

NCT07698600 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-08-21

No results posted yet for this study

Summary

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.

Conditions

  • HIV -1 Infection

Interventions

BIOLOGICAL

BNT168

Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections

OTHER

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-04
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698600 on ClinicalTrials.gov