Clinical Trial

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

Active, Not Recruiting Phase 1/2
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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).
Protocol Amendment History 25 amendments
This ClinicalTrials.gov record has been amended 25 times since 2022-09-16; most recent amendment 2026-03-17.
Status change: Recruiting → Active, Not Recruiting 2025-10-16
Status change: Active, Not Recruiting → Recruiting 2025-03-20
Status change: Recruiting → Active, Not Recruiting 2024-08-23
Status change: Not Yet Recruiting → Recruiting 2023-08-15
Trial Details
NCT Number NCT05547464
Lead Sponsor BioNTech SE
Conditions Tuberculosis
Enrollment 497 participants
Start Date 2023-07-31
Primary Completion 2026-03-12 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-18