TBVI
TuBerculosis Vaccine Initiative (TBVI) is an European based foundation that facilitates the development of new tuberculosis vaccines. Goal is to protect future generations against tuberculosis.
TBVI supports an integrated network of more than 40 universities, institutes and industries. They develop more effective, safe vaccines that will be globally accessible and affordable. Research conducted by TBVI's mostly European based network has resulted in several vaccine discoveries (see track record).
Vaccines to be developed
TBVI plans to develop two types of vaccines:
- Priming vaccines that could be given to newborns, which are also protective in latently infected persons and safe in persons with HIV.
- Boosting vaccines to be used in infants, adolescents or young adults, protecting both non-infected as well as latently infected persons from developing TB.
Furthermore, TBVI has a program to develop biomarkers (used to monitor the effectiveness of new vaccines) to increase performance and speed of vaccine development. Biomarkers can provide early insight into the likely effect of a vaccine in different populations and as such can be used as a selection tool before starting long and costly clinical trials. Biomarkers can be useful tools to monitor vaccine trials.
Why new vaccines
Currently there is only one vaccine against tuberculosis available worldwide: Bacille Calmette-Guérin (BCG). This vaccine, used since 1921, can protect children from severe forms of tuberculosis. However, BCG has little to no efficacy in preventing pulmonary TB in (young) adults, the most common and most infectious form of tuberculosis. Moreover, there are serious safety concerns regarding the use of BCG in HIV infected newborns.
More effective, safe vaccines to improve or replace BCG are urgently needed as tuberculosis keeps taking its toll. TB causes almost 2 million deaths a year and the burden of the disease, affecting economies worldwide, is estimated at hundreds of billions of dollars annually. Vaccines – generally accepted as and proven to be both a very efficient and cost-effective way of preventing infectious diseases – can make the difference.
Modeling studies show that without new vaccines TB can never be eliminated. New vaccines, together with more accurate diagnostics and more efficient [...] therapies, would save tens of millions of lives. Vaccines will also be especially crucial in combating multidrug-resistant tuberculosis (MDR-TB) and extensively [...] resistant tuberculosis (XDR-TB), forms of TB that are expensive and extremely difficult or virtually impossible to treat.
History
On suggestion of the European Commission - in 2008 TuBerculosis Vaccine Initiative (TBVI) was founded to collect additional funds from governments, non-governmental organizations, foundations, private industry and other private funders.
Track Record
The TBVAC project (2004–2009) – the European Union funded project TBVI managed and evolved from – resulted in:
- 4 new vaccine candidates in preclinical and non clinical stages
- 4 new vaccine candidates in clinical phase I to II (testing safety and immunogenicity)
- 15 candidate biomarkers (used to monitor the effectiveness of new vaccines) with the potential to be used in monitoring of clinical trials
- 3 adjuvant molecules (used to enhance the immunogenicity and therefore the efficacy of vaccines), 1 of which is in clinical phase I studies.
The most advanced vaccine candidate is currently being tested for efficacy in a Phase IIb study. If successfully tested in further clinical stages this vaccine could hopefully be licensed by 2017.
Funding and support
TBVI's activities are currently being funded by:
- The European Union 7th framework programme
- The Bill & Melinda Gates Foundation
- The Calouste Gulbenkian Foundation
- The following sponsors: GSK Biologicals, Institut Merieux, FIT Biotech Ltd
Furthermore, TBVI has the support of the European Parliament
Council of Trustees
- Mr. Jacques-François Martin, Chairman and CEO, Parteurop, former president of The Vaccine Fund, former CEO of Pasteur-Mérieux, Lyon, France
- Prof. Barry R. Bloom, Professor and Joan L. and Julius H. Jacobsen Professor of Public Health, Harvard School of Public Health, Boston, United States
- Mr. John Bowis, Former member of the European Parliament, former Minister of Health and Transport of the UK, London, Great Britain
- Prof. Christian Bréchot, Vice President of Medical and Scientific Affairs, Institut Mérieux, Lyon, France
- Mr. Philippe Busquin, Former member European Commission, former Belgian Minister Education, resp. Interior and Social Affairs, founding commissioner EDCTP, former Member European Parliament, Seneffe, Belgium
- Dr. Dorette Corbey, Director of Advisory Council for Science and Technology Policy (AWT), former member of European Parliament, Haarlem, The Netherlands
- Dr. Jan Gheuens, Senior Program Officer Tuberculosis, Bill & Melinda Gates Foundation, Seattle, United States
- Prof. Michel D. Kazatchkine, Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, Geneva, Switzerland
- Prof. Charles Mgone, Executive Director EDCTP (European and Developing Countries Clinical Trials Partnership), The Hague, The Netherlands
- Prof. Peter Piot, Director of London School of Hygiene and Tropical Medicine, former Director Institute for Global Health Imperial College London, former Executive Director of UNAIDS, London, Great Britain
- Dr. Kalevi Reijonen, President and CEO, FIT Biotech, Tampere, Finland
- Prof. Jorge Soares, Director of Health and Human Development Department, Gulbenkian Foundation, Lisbon, Portugal
- Prof. Hans Wigzell, Professor and Deputy Chairman, Karolinska Institute, former President of Karolinksa Institute, Stockholm, Sweden