TB-VAC - An Integrated Project for New Vaccines against Tuberculosis
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 optimized for evaluation in Phase I clinical trials. TB-VAC consists of two tracks. Track 1. Optimisation of existing vaccine candidates towards Phase I trials. This track is composed of a strategic research component (WP1, 4 and 5) and a down stream development component (WP6). The strategic research focuses on goal-oriented research to optimize delivery and composition of during FP5 selected, promising candidate vaccines (eg, 72F, Hyb-1,85A) and on identification of correlates of protection and markers of TB disease for monitoring of future clinical trials. The downstream development component will carry out GMP production of optimised vaccine candidates, establish pre-clinical files and carry out Phase I clinical trials in European and TB-endemic countries. According to the results, the Consortium will decide upon a strategy to exploit this portfolio. Track 2. Discovery of new vaccine/antigens (WP2 and 3). This track will carry out innovative back-up research to identify and develop novel vaccines/antigens. In WP3, we will focus on subunit vaccines based on dormancy related antigens. In WP2, we proposes to optimise three selected live vaccine candidates that during FP5 showed improved efficacy as compared to BCG and show promise as vaccines in infants. Thirty institutions will participate at the start of this effort including two vaccine producers. Subcontracting will likely involve SMEs. Joint partnerships and funding of GMP production with MUVAPRED will exist.