Green light for clinical trial of new tuberculosis vaccine candidate
European scientists are one step closer to delivering a new, safe and more effective vaccine against tuberculosis developed through EU research funding. Swiss-medic, the Swiss regulatory authority for medicine, has given permission to start assessing the new TB vaccine in healthy adult volunteers, paving the way for trials to start. The vaccine, MTBVAC, will be the first of its kind to start clinical evaluation.
European Commissioner for Research, Innovation and Science Máire Geoghegan-Quinn said: "Tuberculosis is a killer that claims 7 victims every hour in Europe alone, with particularly drug-resistant strains emerging. That is why the European Union is investing so much to combat this disease. This new vaccine has been under development for more than a decade in many different laboratories in Europe. Few countries could undertake such a sustained effort on their own. It is a good example of the collaborative character of European research."
MTBVAC, as the vaccine is called, is the first to be based on Mycobacterium tuberculosis, the very bacterium that causes TB. This so-called live vaccine should stimulate the human immune system to recognise and eventually prevent TB infection. Pre-clinical tests have involved various partners of the TuBerculosis Vaccine Initiative (TBVI), a consortium set up and part-funded by the European Commission to facilitate TB vaccine research. The clinical trials will be performed under the supervision of Professor Francois Spertini of the University of Lausanne in Switzerland.
Professor Carlos Martin of Zaragoza University in Spain, the vaccine's lead developer, said: “Being able to start clinical trials is a great step, and very important for the whole field, since MTBVAC is such a new concept. The only currently available vaccine, BCG, provides very limited protection against TB. If MTBVAC successfully runs through all phases of clinical evaluation and shows to be more effective, it could replace BCG.”
If the vaccine manages to pass safety tests and shows good immune responses, the next phases of evaluation will involve larger and younger groups of volunteers. The researchers are hoping to deliver a vaccine that offers life-long protection against all forms of TB, stressing that this would also be an important part of the solution for drug resistant tuberculosis.
The development of MTBVAC has been made possible through a unique European collaboration supported through the European Union's 5th, 6th and 7th framework programmes for research and technological development. It is currently being financed through the NEWTBVAC project, which is receiving an EU contribution of €12 million.
With nearly nine million new cases and 1.4 million deaths worldwide per year, tuberculosis is a colossal public health problem which leaves no country unaffected. In the European region alone it causes 49 new cases and kills 7 people every hour, according to the World Health Organisation. Resistance against treatment with the most common antibiotics is a growing problem.
On top of that, tuberculosis forms a significant financial and economic burden. The only currently available vaccine, BCG, has not been effective enough to stop the TB epidemic. New, safe, more effective vaccines are urgently needed.
European efforts to find new TB vaccines are united through the TuBerculosis Vaccine Initiative (TBVI). Set up in 2008, TBVI financially supports and brings expertise to an integrated network of over 50 universities, institutes and industries to develop more effective, safe vaccines that will be globally accessible and affordable.
Michael Jennings, +32 229 633 88
Spokesperson, European Commission, DG Research & Innovation
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