India is likely to start HIV vaccine trial at two sites in Pune and Chennai by the end of this year and the involved agencies are awaiting the green signal from the Drugs Controller General of India (DCGI), according to N K Ganguly, director general, Indian Council of Medical Research (ICMR), New Delhi.

The National AIDS Research Institute (NARI) in Pune and the National Institute of Epidemiology, Chennai, will undertake the trials and has established adequate infrastructure to conduct the research and the trials, headed by ICMR. The third centre at Kolkotta would be ready for the trials in one or two years as the process of infrastructure creation was being done, said Ganguly in Chennai this week while participating in a continuing medical education programme on HIV and tuberculosis organized by the Tuberculosis Research Centre (TRC), Chennai, and the National Academy of Medical Sciences (NAMS), New Delhi.

He said the trial, slated to start by the beginning of this year, was postponed due to delay in the clearances. ICMR hopes to get nod from the DCGI at the earliest and to start the trials during the last quarter of this year. The recombinant Adeno-Associated Virus (AAV) vaccine has been found to be safe and this single shot vaccine administered in primates has found to neutralize the antibodies for at least one year. Preparations are also being done to conduct clinical trials of the multiple vaccine.

In order to monitor the vaccine trials, the government would form an independent monitoring committee, besides a data safety management committee comprising representatives from the public. The process would be completely transparent during the entire clinical trial period. The volunteers who partake in the trials would be given insurance coverage. Volunteers for the first phase would comprise from the low risk category and the first phase trials could last for about one year.

The phase II trials would include high-risk category volunteers. Chennai and Pune were chosen for the trials based on the available epidemiological data and possibility of low migration of volunteers, said the ICMR chief.

He said the prime aim of the phase I trials would be to ascertain the safety of the vaccine and to study its immunological effects on human beings.