With nearly nine million new cases and 1.5 million deaths per year, tuberculosis is a major global health threat, apart from entailing significant financial and economic burdens. The increase and spread of drug resistant TB makes the problem even more dangerous. The only currently available vaccine, BCG, offers limited protection and is not effective enough to stop the TB epidemic. New safer and more effective vaccines are therefore urgently needed.
European scientists seem to be one step closer to delivering one such vaccine against tuberculosis. Swiss-medic, the Swiss regulatory authority for medicine, has given permission to start assessing the new TB vaccine candidate MTBVAC in healthy adult volunteers. MTBVAC is a prophylactic vaccine targeted at the new born. It is a live vaccine based on attenuated Mycobacterium tuberculosis: a strongly weakened version of the bacterium that causes TB. Made harmless in the laboratory, the vaccine stimulates the human immune system to recognise, and eventually prevent, TB disease.
This new vaccine has been under development for over 15 years in many different laboratories in Europe and is a good example of collaborative research. It is purported to be the first candidate of this kind ever to be tested in humans and preclinical data has already shown very promising results. Its developer Professor Carlos Martin, of the University of Zaragoza Spain, is optimistic that, “Being able to start clinical trials is a great step, and very important for the whole field, since MTBVAC is such a new concept, and the only currently available vaccine, BCG, provides very limited protection against TB.”
The clinical studies will be performed under the supervision of Professor Francois Spertini of the University of Lausanne in Switzerland. According to information received from him, “Recruitment of 36 volunteers of both sexes, aged between 18 to 45 years has already begun. We expect to do the first injections in January 2013 and the first results are expected by the end of that month. If this trial is successful, it will then be repeated in adolescents and then finally in children for safety. In phase II study it will be tested in children and then later for efficacy.”
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.”
The development of MTBVAC has been 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 Spain, 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.
If the vaccine manages to pass this first human safety test 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. If MTBVAC successfully runs through all phases of clinical evaluation and shows to be more effective it could replace BCG.
Of course, there is still a long way to go. Granted that all goes well, the expected time line for the vaccine to become a reality is around 10 years as there are several phases of clinical studies. Once that final stage is reached, let us hope that its manufacturing and marketing will be targeted at the weaker sections of society so that the vaccine can be accessed by all those who are in need of it, irrespective of their economic and social status.
Shobha Shukla - CNS
(The author is the Managing Editor of Citizen News Service (CNS). She is a J2J Fellow of National Press Foundation (NPF) USA. She received her editing training in Singapore, has worked earlier with State Planning Institute, UP and taught physics at India's prestigious Loreto Convent. She also authored a book on childhood TB (2012), co-authored a book (translated in three languages) "Voices from the field on childhood pneumonia" and a report on Hepatitis C and HIV treatment access issues in 2011. Email: shobha@citizen-news.org, website: http://www.citizen-news.org)
