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Discovery and preclinical testing of new vaccine candidates for tuberculosis
Framework programme:
Project number:
EC contribution:
€ 11,900,000
48 months
Funding scheme :
Collaborative Project (Large-Scale Integrating Project)
Starting date:

Keywords: Tuberculosis, Vaccines, Biomarkers


Approximately 2 billion people worldwide are believed to be infected with Mycobacterium tuberculosis. Multidrug resistant (MDR) tuberculosis (TB) accounts for 0.5 million cases, and extensively-drug-resistant (XDR) TB was reported in at least 49 countries. Both MDR-TB and XDR-TB are increasing in both the developing and developed world. Current global TB control is based primarily on efforts to reduce transmission by prompt diagnosis and treatment of infectious cases using the DOTS (Direct Observed Treatment Short Course) strategy. With the DOTS strategy, 61% of new smear-positive cases are currently detected and 84.7% of them are successfully treated. In addition to diagnosis and treatment, approximately 100 million doses of Bacillus Calmette-Guérin (BCG) are given each year in neonatal vaccination programmes in endemic countries. It is estimated that the current programme prevents around 30 000 cases of TB meningitis and 11 000 cases of miliary TB every year. BCG is ineffective against the predominant pulmonary forms of TB in adolescents and adults, and is not known to protect latently infected individuals from developing the disease.

To achieve effective and sustainable control of TB, there is a need for vaccines that can reduce the development of disease in adolescents and adults following exposure to new infection, and in the 2 billion individuals who have already been exposed to infection. Nine new candidates are now being evaluated in phase I and II clinical trials. Two types of vaccines are currently in development, firstly subunit booster candidates to be used in BCG-vaccinated individuals, and secondly safer and more effective live priming candidates that aim to replace BCG. While a number of these first-generation vaccines are now in phase I or phase II clinical trials, it should be anticipated that a number of these first-generation vaccines may have suboptimal efficacy, and that second generation or alternative priming and booster vaccines will need to be developed. Moreover, new vaccines are needed that protect the 2 billion latently infected individuals, and currently such 'post-exposure vaccines' are not available. Second generation vaccines therefore, either alone or in combination with existing candidates, not only need to be able replace or boost BCG, but also will need to reduce development of disease in exposed individuals.

NEWTBVAC will be coordinated by TBVI project.

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