The Hindu : Indigenous AIDS vaccine trials by year-end

Online edition of India's National Newspaper
Thursday, Apr 17, 2003

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Indigenous AIDS vaccine trials by year-end

By Our Staff Reporter

CHENNAI APRIL 16. The first clinical trials of a preventive AIDS vaccine developed in India will begin by the end of the year at the National AIDS Research Institute (NARI), Pune.

Announcing this at a press conference today, representatives of the International AIDS Vaccine Initiative (IVAI) said the first phase of the trial will involve 40 volunteers, healthy adults with low risk for HIV infections. The vaccine, which will counter the strain of HIV subtype C prevalent in India, has been developed by the Indian Council for Medical Research (ICMR) in collaboration with the National AIDS Control Organisation (NACO) and IVAI.

The trial will follow standardised, codified procedures prescribed at the international level and will go on for 12 months, extendable to 18 months from the date of the first injection. Volunteers will be split into two groups: while one group will be administered placebos, the other will be injected with varying doses of the vaccine at an interval of 0, 2 and 4 months. The immune responses will be studied over a period of 12 months and if necessary, an additional six months, according to Dr. Jean Luis Excler, medical director, IVAI.

If satisfactory immune responses are recorded in this phase, then the trial will progress to the second and third phases of the study, when high risk groups will be targetted for establishing `efficacy'. In preparation, a new and independent laboratory exclusive for HIV vaccine trials will be set up. A behavioural study is being undertaken to determine the willingness of probable volunteers to participate in the trial. The clinical protocol will be finalised by a team of NARI scientists by the end of May.

Dr. Excler said the medical director, ICMR, N.K. Ganguly, has extended support to the IVAI to set up a second clinical trial centre at the Tuberculosis Research Centre in Chennai to test another vaccine. A committee comprising experts will be formed to review the portfolio of potential new vaccines and include them in the trials, he added.

In this context, a state level meeting, `Working together for an AIDS Vaccine for India' will be held at the IMAGE auditorium in the city tomorrow to interact with representatives of civil society on the vaccine trial preparedness. The meetings, which will be conducted in other parts of the country as well, aim at arriving at a broad consensus on the best way to take the AIDS vaccine trials forward in India, according to Mark Chataway, team leader, IVAI.

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