A global initiative to develop new tuberculosis vaccines to supplement the now 90-year-old Bacille Calmette-Guérin (BCG),commonly administered to infants as part of vaccination protocols,will feature India as one of the sites for trials. The first TB vaccine trials in India in over four decades,funded by the global tuberculosis vaccine initiative Aeras,will be conducted by the Bangalore-based St Johns National Academy of Health Sciences at a site at Palmaner,Andhra Pradesh. Though BCG is still an effective protector against tuberculosis in children,its reliability in preventing tuberculosis of the lungs in adults and countering drug-resistant varieties is in question and this has resulted in the quest for a new vaccine. The vaccine candidate identified for trials in India,out of half a dozen being developed under the Aeras initiative the world over,is AERAS-402 / Crucell Ad35. It will be tested on BCG-vaccinated adults. The first phase which involves safety tests and their validation has been completed and we are awaiting its results to start the second-phase efficacy trials. The results are being studied at a laboratory in the United States, said Dr John Kenneth,head of the infectious disease unit and molecular diagnostics at the St Johns Research Institute who is the key collaborator for the trials. Aeras is helping the St Johns National Academy of Health Sciences (of which the research institute is a part) develop infrastructure to conduct the trials at Palmaner under the collaboration agreement signed in July 2008. Bangalore-based Lotus Labs will provide validation for the data. To conduct large-scale Phase III efficacy trials,Aeras has formed partnerships with research organisations in countries with high rates of TB, says the Aeras website. Aeras is a not-for-profit product development organisation funded by the Bill and Melinda Gates Foundation,the US Food and Drug Administration,the Dutch and British governments,and others. The director of the National Centre for Biological Sciences at the Tata Institute of Fundamental Research,Dr K Vijay Raghavan,is the Indian member on a board of nine directors. Dr Raghavan told The Indian Express,India must be a full partner to any solution,as this broadens ownership and responsibility. TB is exemplary of many diseases. Its prevalence and spread have varied causes in each social context and in the context of each persons immune system. Understanding the mycobacterium and its biology in the context of the immune system is vital to the generation of an effective vaccine. In combining in-house laboratory excellence with collaborations globally,Aeras brings in a whole range of efforts required for an effective vaccine. The last time a TB vaccine trial was conducted in India was in the mid-1960s with BCG,with funding from WHO and the US government,at Chingleput in Tamil Nadu. According to the National Tuberculosis Institute,a revolutionary report of the trial that was released over 12 years later showed the BCG vaccine did not provide significant protection against tuberculosis of the lungs. The Indian Council of Medical Research and WHO decided that though BCG may not protect against TB of the lungs which occurs mostly in adults,it could provide substantial protection against childhood forms,said the institute.
