Lessons learnt from the first efficacy trial of a new infant tuberculosis vaccine since BCG.

Background: New tuberculosis (TB) vaccines are being developed to combat the global epidemic. A phase IIb trial of a candidate vaccine, MVA85A, was conducted in a high burden setting in South Africa to evaluate proof-of-concept efficacy for prevention of TB in infants.

Objective: To describe the study design and implementation lessons from an infant TB vaccine efficacy trial.