The world needs new vaccines to replace or improve BCG, the only avaible vaccine against tuberculosis. BCGin preventing pulmonary TB in (young) adults, the most common and most infectious form of the disease.
New vaccines should protect everybody from tuberculosis. The vaccines should also prevent tuberculosis in people with a latent or ‘sleeping’ TB infection (which is not contagious but can still develop into TB later in life) and be safe in people living with HIV.
TBVI aims to develop two types of vaccines (see
1) priming vaccines that could be given to newborns, which are also protective in latently infected persons and safe in persons with HIV.
2) boosting vaccines to be used in infants, adolescents or young adults, protecting both non-infected as well as latently infected persons from developing TB.
Furthermore, we have a program to develop biomarkers (used to monitor the effectiveness of new vaccines) to increase performance and speed of vaccine development. Biomarkers can provide early insight into the likely effect of a vaccine in different populations and as such can be used as a selection tool before starting long and costly clinical trials. Biomarkers can be useful tools to monitor vaccine trials.
TBVI also has one program for infrastructure supporting activities to improve the capacity of existing clinical trial sites. Currently there is a lack of sufficient trial capacity for evaluating TB vaccines. TBVI wants to contribute to improvement of this situation by selecting 1 to 3 sites with existing TB research capacity and providing support to make these sites suitable for carrying out Phase I trials (testing safety).
We aim to raise 200 million euros over the next ten years to bring 8 vaccines to phase II of clinical trials (testing safety and efficacy), to deliver 3 biomarkers that will offer tools to validate vaccines quicker and more precisely, and to improve trial capacity for evaluating TB vaccines (see table).
Costs (in million €)
5 vaccines ready for Phase II between 2009-2020
2. Priming vaccines that could replace BCG
3 vaccines ready for Phase II between 2009-2020
3 assays between 2015-2020
4.Infrastructure supporting activities
1-3 existing clinical trial sites