The Hindu Business Line : Chennai likely to be AIDS vaccine trial site

A DELAY of more than six months notwithstanding, work on the India-specific AIDS vaccine is progressing, with the International AIDS Vaccine Initiative (IAVI) scouting for a second site, most likely in Chennai, to conduct phase I clinical trials.

The Indian Council of Medical Research (ICMR) is partnering this project with IAVI and the two likely institutes identified in Chennai to take the phase I trials forward are ICMR's Tuberculosis Research Centre (TRC) and the National Institute of Epidemiology (NIE) - pending approval from their respective scientific boards.

Mr Mark Chataway, IAVI's Team Leader-India, told Business Line that TRC has been identified as the second site for phase I clinical trials, provided it is cleared by its scientific board. Pending similar clearance, NIE would possibly take up larger efficacy trials for the Indian sub-type C vaccine. The first site identified to undertake phase I trials is Pune's National AIDS Research Institute (NARI). Phase-I trials involve about 50-100 human volunteers who would be given the vaccine.

IAVI's vaccine project is at different stages of progress in other countries, including the UK and Kenya. But in India, IAVI officials expect the vaccine to go into phase I trials in the first-half of 2004. IAVI has a vaccine development agreement with the US-based Therion Biologics, where the company would develop the vaccine candidate for the Indian sub-type. However, technology would be transferred to Indian companies for production of vaccines to support Phase II trials, as envisaged by IAVI's agreement with the Indian Government, Mr Chataway said.

While the most optimistic date for an actual AIDS vaccine, developed out of any of the locations, is as far away as 2010 - the agreement with India is to keep the vaccine accessible to people who need it in the region, by keeping it at an affordable price, he said. Further, India would have the rights to the vaccine in the SAARC region.

Feasibility studies are also on for sites to conduct phase II and phase III trials and locations are being looked at in Maharashtra, Andhra Pradesh, Tamil Nadu and Karnataka. Early 2004, locations would be looked at in the north-eastern States, as well.

Meanwhile, preparing for the ethical issues related to conducting clinical trials, the project is also putting in place mechanisms to take care of counselling the humans involved in trials, he said. "The system is being dry run before it gets into the critical system of testing the vaccine."

Allaying fears of infecting people, he said: "Only fragments of the virus are being injected in clinical trials and a person cannot become HIV positive through this. Nevertheless, the proceedings would be overseen by a high-powered group with people from different walks of life."

Meanwhile, industry sources told this correspondent that ICMR had already put out advertisements to decide on companies that would produce the vaccines to support later trials of the vaccine.

"There were six submissions of intent, and three companies have been zeroed in after ICMR reviewed the proposals," the industry official said.

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