Promising TB vaccine candidate progresses to Phase I clinical trials
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.
Update 31 May:
The media coverage about this news was very broad, especially in Spain. A short overview:
- Spanish Television (at 12.55 min)
- Television de Galicia (click on the left side)
- La Voz de Galicia (video)
- Citizen News Service: Promising TB vaccine candidate progresses to Phase I clinical trials
- Atlantico: Clinical trials of a new vaccine against tuberculosis (translated by google)
- Que: Biofabri starts in 2012 for human clinical trials in 2016 to market a vaccine against tuberculosis (translated by google)
- PMFarma: Biofabri expected to launch in 2016 its TB vaccine (translated by google)
- NoticiaSalud: Available the first batch of the tuberculosis vaccine, designed by the University of Zaragoza (translated by google). Also in Microbiology News, SINC,
- Europapress University of Zaragoza and Biofabri develop a vaccine against tuberculosis 5 million investment (translated by google)
- Farodevigo: Biofabri open another plant in Porrino for TB vaccine (translated by google)
- Faro de Vigo: Biofabri is preparing to test its vaccine against human tuberculosis (translated by google)
- La Voz de Galicia: "There are already several multinationals interested in marketing" (translated by google)
- La Voz de Galicia: A vaccine made in Porriño tackle tuberculosis in 2050 (translated by google)
- La Voz de Galicia: Biofabri Galician company handles the human trial of its vaccine against tuberculosis (translated by google)
- El Economista: Biofabri expected to launch in 2016 its TB vaccine (translated by google) Also in El Digital de Madrid
- AltoAragon: The tuberculosis vaccine be tested in animals Zaragoza
- El Correo Gallego: Believe Porriño tuberculosis vaccine (translated by google)
- 20 Minutos: Biofabri starts in 2012 for human clinical trials in 2016 to market a vaccine against tuberculosis (translated by google)
- Noticias.com The new TB vaccine will soon be submitted to animal toxicity studies. Also in Terra Noticias (translated by google)
- El Norte de Castilla: Tuberculosis vaccine designed in Zaragoza begin animal testing (translated by google)
- Noticia Salud: Available the first batch of tuberculosis vaccine, designed by the University of Zaragoza (translated by google)
- Working Group on New TB Drugs: Promising TB vaccine candidate progresses to Phase I clinical trials. Also in Journalists Against TB and Science and Development Network