NCT05537038

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers

A Phase Ia, Randomized, Placebo-controlled, Double-blind, Dose-finding Evaluation Trial to Describe the Safety, Reactogenicity, and Immunogenicity of Two Investigational Vaccines Against Tuberculosis in IGRA-negative, BCG naïve Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This randomized, placebo-controlled, double-blind, safety and dose-finding Phase Ia trial will evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule.

Detailed description

Enrollment for BNT164a1 and BNT164b1 will be conducted independently, and in parallel. The trial will enroll participants divided into eight dose groups by dose level (4 dose levels per vaccine, i.e., BNT164a1 and BNT164b1) who will be randomized 7:1 to BNT164 (BNT164a1 or BNT164b1):placebo. The trial will use a staggered dose escalation schema with sentinel participants for Dose 1 in all dose groups. The first dose escalation decision will be made based on data from the first 8 participants. The second dose escalation decision will take into account all safety data from participants enrolled in that group. All safety data, e.g., from the 16 participants in the first dose level, will be used for making decisions at higher dose levels.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	BNT164a1	Multi-antigen ribonucleic acid (RNA) vaccine for active immunization against tuberculosis administered as intramuscular injection
BIOLOGICAL	BNT164b1	Multi-antigen ribonucleic acid (RNA) vaccine for active immunization against tuberculosis administered as intramuscular injection
OTHER	Placebo	Placebo

Timeline

• Start date: 2023-04-18
• Primary completion: 2025-06-06
• Completion: 2025-12-08
• First posted: 2022-09-13
• Last updated: 2025-12-22

Locations

3 sites across 1 country: Germany