CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 120 enrolled
Drug / intervention
BNT164a1 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05537038
NCT05537038Phase 1Completed

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

BioNTech SE·interventional·Posted Sep 13, 2022·Updated Dec 22, 2025

In Brief

A Phase 1 clinical trial evaluating BNT164a1, BNT164b1, and 1 other intervention for Tuberculosis. Completed, enrolled 120 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedSep 13, 2022
Enrollment StartApr 18, 2023
Primary CompletionJun 6, 2025
Study CompletionDec 8, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 3.8 years ago

Interventions

BNT164a1biological

Multi-antigen ribonucleic acid (RNA) vaccine for active immunization against tuberculosis administered as intramuscular injection

BNT164b1biological

Multi-antigen ribonucleic acid (RNA) vaccine for active immunization against tuberculosis administered as intramuscular injection

Placeboother

Placebo