The MTBVAC01 vaccine candidate, developed to protect people against tuberculosis, will start Phase I clinical trials early in 2012. This was announced by the Spanish biopharmaceutical company Biofabri. The candidate was developed by the University of Zaragoza, Spain and is part of the international portfolio of TuBerculosis Vaccine Initiative (TBVI). Tuberculosis causes almost two million deaths per year.
During a press conference Biofabri’s CEO Esteban Rodriguez explained that the first batch of the vaccine is now available for toxicity studies. After the results of these studies have been assessed by the European Medicines Agency, responsible for accrediting and authorising, the candidate will move to Phase I of clinical trials in humans. Phase I studies are conducted in small groups of healthy adults to check if the new vaccine can be given without any serious side effects or reaction and that it produces a good immune response. If the results are positive the vaccine candidate will move on to Phase II.
MTBVAC01, designed by TBVI’s research partner Carlos Martin of the University of Zaragoza, could replace the current BCG vaccine. It is the first and leading attenuated live vaccine globally. The results from the laboratory predict a firm protection against TB; this has to be proven in the coming years.
The research team, which has spent four years working on this project, aims to produce a vaccine that will be ‘universally accessible’, protecting millions of people around the world. According to the project’s scientific director Carlos Martin, the disease is becoming more resistant to antibiotics. Tuberculosis is the most important cause of death among people with HIV infection.