Live-attenuated Mycobacterium tuberculosis vaccine, MTBVAC, in adults with or without M tuberculosis sensitisation: a single-centre, phase 1b-2a, double-blind, dose-escalation, randomised controlled trial.

ABSTRACT:

Background

An effective adult vaccine is needed to control tuberculosis. We evaluated the safety and immunogenicity of a live-attenuated Mycobacterium tuberculosis vaccine (MTBVAC).

Methods

This single-centre, phase 1b-2a, double-blind, dose-escalation, randomised controlled trial (NCT02933281) enrolled South African adults previously vaccinated with BCG, who were HIV negative and aged 18-50 years, with or without M tuberculosis sensitisation assessed by QuantiFERON-tuberculosis Gold-Plus assay (QFT). Participants were recruited from the local community and randomly allocated (2:1) to receive MTBVAC (5 × 10³, 5 × 10⁴, 5 × 10⁵, or 5 × 10⁶ colony-forming unit [CFU] doses) or BCG revaccination (5 × 10⁵ CFU dose). The primar

SUBMITTER: Luabeya AKK 

PROVIDER: S-EPMC12780950 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature