Safety, reactogenicity, and immunogenicity of MTBVAC in infants: a phase 2a randomised, double-blind, dose-defining trial in a TB endemic setting.

ABSTRACT:

Background

Safer and more effective tuberculosis (TB) vaccines than Bacille Calmette Guérin (BCG) are needed. We evaluated the safety, reactogenicity, and immunogenicity of three dose levels of the live-attenuated Mycobacterium tuberculosis (Mtb) vaccine, MTBVAC, compared to BCG, in South African infants.

Methods

Healthy, HIV-unexposed, BCG-naïve infants were randomised to receive a single intradermal dose of BCG (2.5 × 10⁵ CFU, n = 24) or MTBVAC (2.5 × 10⁴, 2.5 × 10⁵, or 2.5 × 10⁶ CFU, each n = 25). Safety endpoints were solicited systemic, solicited injection site, and unsolicited adverse events (AE), and serious AE (SAE). Immunogenicity was measured using interferon-γ release assay (IGRA) and whole blood intracellular cytokine s

SUBMITTER: Tameris M 

PROVIDER: S-EPMC12121429 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature