Monday, February 7 2005 16:03 Hrs (IST) - World Time -

Pune: The clinical (Phase I) trial of an investigational vaccine, designed to prevent HIV-AIDS, began on humans in Pune today (Feb 07, 2005) with the participation of 34 volunteers, 60 per cent of whom are women, according Deputy Director of National Aids Research Institute (NARI), Dr Sanjay Mehedale.

The trial was being conducted by a partnership between the Central Government and International AIDS Vaccine initiative.

Taking part in a video-conferencing, Meherdale, the Principal Investigator of the project, said a dose was administered on a volunteer in the afternoon at NARI campus while two more would be administered the dose by the evening.

In next two to three weeks, the first batch, comprising ten volunteers would have been injected with tgAAC09 candidate in their upper arms, he said.

About the profile of the volunteers, he said that they were social workers, office-goers and were youthful but free from major ailments, which was one of the pre-conditions for their selection.

The video conferencing was organised by the Indian Council of Medical Research (ICMR), National AIDS Control Organisation an International AIDS Vaccine Initiative in Delhi, Pune and New York simultaneously and was participated by Kapil Sibal, Union Minister of State, Science and Technology, Dr N K Ganguly, Director General of ICMR and Dr Anbumani Ramadoss, Union Minister of Health and Family Welfare.

The data of the clinical trial of a different candidate for the development of the vaccine, conducted in Belgium and Germany, were available, Ganguly said adding that however, what was still wanted was the information on the immunity parameters and the tests for these were on.

Asked about the reaction expected on the volunteers, he said that they would not be different from that caused by other vaccines and would normally be at the injection site, with the possibility of fever for a few hours.

Basically, it would be a classical reaction caused by the injection of any type, he said, adding that there were three major types of vaccines conforming to the genetic, antibody and immunity make-ups of the volunteers.

On the possibility of any drop-out, he said, "We do not expect anyone to withdraw and in case anyone choosing to back out, there is a provision to enrol a new volunteer" and added that all volunteers have been insured for a five-year period.

To a question, Dr Seth Berkley, President and CEO, IAVI, said that funds for the ongoing clinical trial were restricted as they were normally provided for prevention and care. However, still the funds were not a problem as many countries (about eight) were supporting the programme together with the World Bank and other generous donors.

Asked about the cost that would go into the development of the AIDS vaccine, Berkley said it was a long-drawn process (three stage tests) and would take at least eight to ten years and hundreds of millions of Dollars for the vaccine to become a reality.

The expenses per volunteer was expected to be $ 15 million, he said, adding that the vaccine, whenever it was developed, would be expensive.