Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting.

ABSTRACT:

Background

Vaccination that prevents tuberculosis (TB) disease, particularly in adolescents, would have the greatest impact on the global TB epidemic. Safety, reactogenicity and immunogenicity of the vaccine candidate M72/AS01E was evaluated in healthy, HIV-negative adolescents in a TB endemic region, regardless of Mycobacterium tuberculosis (M.tb) infection status.

Methods

In a phase II, double-blind randomized, controlled study (NCT00950612), two doses of M72/AS01E or placebo were administered intramuscularly, one month apart. Participants were followed-up post-vaccination, for 6 months. M72-specific immunogenicity was evaluated by intracellular cytokine staining analysis of T cells and NK cells by flow cytometry.

Results

No serious adverse events were recorded. M72

SUBMITTER: Penn-Nicholson A 

PROVIDER: S-EPMC5845829 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature