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publicado em 17/10/2012 às 10h00:00
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Europe authorizes human trial of a new vaccine against tuberculosis

Vaccine works by stimulating the immune system to recognize and prevent infection and can replace the current BCG

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European scientists are one step closer to delivering a new, safe and more effective vaccine against tuberculosis. Swiss-medic, the Swiss regulatory authority for medicine has given permission to start assessing the new TB vaccine in healthy adult volunteers. The vaccine, called MTBVAC, is the first vaccine of its kind to start clinical evaluation.

MTBVAC is a live vaccine based on attenuated Mycobacterium tuberculosis; a strongly weakened version of the bacterium that causes TB. " This is the first candidate of this kind ever to be tested in humans," explains Dr Jelle Thole, director of the TuBerculosis Vaccine Initiative (TBVI). " The start of this clinical trial is a big win for scientists all over Europe."

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."

Made harmless in the laboratory, the vaccine stimulates the human immune system to recognise, and eventually prevent, TB disease. Pre-clinical data shows great promise. " Constructing this vaccine required fifteen years of hard work and the help of many, international scientists. It has been a truly European team effort, supported by continuous projects funded by the European commission and the Spanish research and innovation programmes from Genoma España and FECYT," explains its developer Professor Carlos Martin of the University of Zaragoza in Spain. " 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."

European collaboration

The development of MTBVAC has been made possible through a unique European collaboration and was financed in part by the European Commission and Biofabri, a Spanish biopharmaceutical company. The project started with Professor Brigitte Gicquel at Institute Pasteur in Paris, in collaboration with Professor Carlos Martin of the University of Zaragoza, where the actual vaccine was constructed. Pre-clinical development involved various partners of the TuBerculosis Vaccine Initiative (TBVI), a consortium that facilitates and accelerates TB vaccine research and development. Throughout the process, TBVI' s special expert teams have provided scientific support and developmental expertise. The now approved clinical trials will be performed under supervision of Professor Francois Spertini of the University of Lausanne in Switzerland. The development of this vaccine candidate underlines nicely the ability of Europe to translate good ideas into life-saving products.

Professor Spertini is excited about the upcoming tests. " This vaccine candidate is so promising. Because it contains the actual bug that causes TB, we expect it to be much more effective than the existing vaccine. And because very elegant work has been done to modify and weaken the organism, we expect it to be very safe." 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.

For Esteban Rodriguez, CEO of Spanish biopharmaceutical Biofabri, the start of the trials mark a historic milestone. Biofabri, part of the C&B group, produced the vaccines for the clinical trial. " We are proud to sponsor and support this vaccine candidate and we are excited to be involved in this great European project."

The quest for new tuberculosis vaccines

With nearly nine million new cases and 1.5 million deaths per year, tuberculosis is a major global health threat. The increase and spread of drug resistance make the problem of TB even more dangerous and pressing. 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 such as MTBVAC are urgently needed.

European efforts to find new TB vaccines are united and bound together through the TuBerculosis Vaccine Initiative (TBVI). 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. Development teams that can help make the translation from a good scientific idea into a life-saving vaccine are among the key services that TBVI offers.

   Palavras-chave:   Tuberculosis vaccine    Mycobacterium tuberculosis    MTBVAC    Swissmedic    Máire Geoghegan-Quinn   
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