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Delays hit clinical trials of India-specific AIDS vaccine

P.T. Jyothi Datta

Mumbai , May 26

ANOTHER cycle of delays has pushed clinical trials on the India-specific AIDS vaccine being developed by the International Aids Vaccine Initiative (IAVI) to the end of 2004 or early-2005.

Even though the project has identified three vaccine candidates to be developed in India - inadequate toxicology data has pushed the commencement of clinical trials on the MVA vaccine to later this year, Mr Mark Chataway, IAVI's Team Leader-India, told Business Line.

The Indian Council of Medical Research (ICMR) is partnering the project with IAVI and after a couple of time overruns, the phase-I clinical trial on the vaccine was eventually set to commence at Pune's NARI institute in July this year.

"Delays happen in science. We will have to give more data on the studies conducted on animals and documents are likely to be submitted to the Drug Controller General of India (DCGI) in a few months," he said.

Meanwhile, one of the three other vaccine candidates will also be put up for approvals and could go in for phase-I trials, subject to getting the necessary clearance soon enough, he said. Phase-I trials involve about 50-100 human volunteers who would be given the vaccine.

"But under no circumstance will a healthy volunteer be injected with the AIDS virus or develop the illness as a result of participating in the clinical trial," he stated, in an effort to allay the fears that abound around the AIDS-vaccine trials.

"Tiny fragments of the virus are injected in a disguised form. These fragments will not recombine to from the virus, so the fear in this case is unfounded," he added.

Meanwhile, ICMR had called for local pharma companies to participate in the project and support later stages of vaccine-trial by producing the vaccines locally.

"Eight companies had applied and the issue is currently undergoing negotiations at a commercial stage. Vaccines for phase-I trials would be developed by the US-based Therion Biologics. But as the vaccine goes into future trials, the technology would be transferred to an Indian company that has been identified by the Indian Government," he said.

On whether the delay has caused a cost overrun, he said that IAVI had earmarked funds for the early development of the vaccine.

"The big question is with regard to the later stage of vaccine development. If an AIDS vaccine is developed, then how it would be made affordable to the poor, for instance, is another issue. We are working on a contingent purchase fund, with donations from industrialised nations, besides looking at other alternate mechanisms," he said.

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