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

ABSTRACT:

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.

Methods

This was a randomised, controlled, double-blind clinical trial comparing the safety and efficacy of MVA85A to Candin control administered to 4-6-month-old, BCG-vaccinated, HIV-negative infants at a rural site in South Africa. Infants were followed up for 15-39 months for incident TB disease based on pre-specified endpoints.

Results

2797 infants were enrolled over 22 months. Factors a

SUBMITTER: Tameris M 

PROVIDER: S-EPMC3608032 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature