With a global incidence increasing at 2% and two million deaths each year, tuberculosis (TB) demands the highest priority among communicable diseases linked to poverty. In developing countries, the vast majority of the TB cases affect the young adult population, increasing its economic impact. The TB-VAC project aims to develop improved vaccines, particularly for the young adult population. Vaccine candidates and strategies will be optimised for evaluation in Phase I clinical trials. TB-VAC is made of three components.

1) A vaccine discovery component will carry out innovative back-up research to identify and develop novel vaccines or antigen components in addition to those developed within the TB vaccine cluster of the FP5 programme. This component thus consolidates the vaccine candidate portfolio established in FP5.

 

2) A strategic research component will carry out goal-oriented research to optimise the delivery and composition of new and current candidate vaccines for down-stream development and evaluate them in animal models in terms of safety, immunogenicity and protection. Second generation vaccine candidates will be selected for evaluation in clinical trials to identify correlates of protection and markers of TB disease for monitoring of future clinical trials.

 

 

3) A downstream development component will carry out GMP production of vaccine candidates, establish pre-clinical files and carry out Phase I clinical trials in European and TB-endemic countries. According to the results of early clinical phase trials of the candidates identified in FP5, the Consortium will decide upon a strategy to exploit this portfolio. Thirty-nine institutions will participate in this effort including two vaccine producers and one SME.