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

Summary

This is a two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule. This study includes: Part A (Phase Ib) and Part B (Phase IIa).

Timeline

Start

2023-07-31

Primary completion

2026-03-12

Completion

2027-01

Publications

• Agrawal N, Ates LS, Schille SA, Chaturvedi A, Vogt J, Vukovic N, Dulberger CL, Vogel AB, Diekmann J, Diken M, Sahin U. mRNA-based tuberculosis vaccines BNT164a1 and BNT164b1 are immunogenic, well tolerated and efficacious in rodent models. Nat Immunol. 2026 Jun 12. doi: 10.1038/s41590-026-02545-z. Online ahead of print.

Drugs

Indications