Trial Profile

A Phase Ib/IIa Two-part, Randomized, Placebo-controlled, Observer-blind, Dose-finding Evaluation Trial to Describe the Safety, Reactogenicity, and Immunogenicity of Two Investigational Vaccines Against Tuberculosis in BCG Vaccinated, HIV-negative Subjects and People Living With HIV

Status: Active, no longer recruiting

Phase of Trial: Phase I/II

Latest Information Update: 28 Oct 2025

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At a glance

20 Oct 2025 Protocol has been amended to include four new arms (Experimental: Part B: BNT164a1 Dose level (DL) 1, Experimental: Part B: BNT164a1 DL 2, Experimental: Part B: BNT164b1 DL 1 and Experimental: Part B: BNT164b1 DL 2) , it has changed from 3 to 7.
20 Oct 2025 Planned End Date changed from 1 May 2027 to 1 Dec 2026.
20 Oct 2025 Planned primary completion date changed from 1 Jun 2026 to 1 Mar 2026.

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