The Hindu Business Line : Human trial of AIDS vaccine begins

AT about 12.30 p.m., the first shot of the investigational HIV/AIDS vaccine was administered on a healthy volunteer at the National AIDS Research Institute (NARI) in Pune reiterating India's commitment of developing a preventive therapy to combat the virus that is the cause of an epidemic.

Announcing the commencement of the first-ever human clinical trial of the vaccine, Health Minister, Dr Anbumani Ramadoss said, "The vaccine candidate is being tested on 30 healthy volunteers in the Phase I clinical trial at the NARI."

The `Adeno Associated Vector Borne Vaccine' is being designed to target HIV sub type C, one of the most commonly found strain in India, which is present in over 90 per cent of the infections.

This is being developed as a joint initiative between the Government - the Indian Council of Medical Research (ICMR) and the National AIDS Control Organisation - and the International AIDS Vaccine Initiative (IAVI), an international not-for-profit organisation.

According to Dr N.K. Ganguly, Director-General of the ICMR, it could take anything between 8-10 years to complete the three-phase trials and start commercialisation. "It can take one year to complete the trials and another six months for its evaluation. The trials would ensure that India does not lag behind the rest of the world in AIDS vaccine area. The vaccine would be available in India at the same time as the rest of the world."

Besides India, Phase I trials for this vaccine has been completed in Germany and Belgium. "The trial in India is part of a multi-country initiative of the same vaccine candidate. Initial trial results in Germany and Belgium have given excellent safety data," said Mr Kapil Sibal, Minister for Science and Technology.

The country is working on at least two other vaccine candidates. The clinical trial of a second vaccine called `MVA' is likely to begin after four-five months from now in Chennai.

Stressing on the importance of political commitment to combat the deadly disease of HIV/AIDS, Dr Seth Berkley, President of IAVI, said "Political commitment in India has been stronger than in any part of the world. India can be a model for the rest of the world."

He added that $10-15 million have already been spent on this vaccine and it could take millions more to develop it further. The IAVI is also in dialogue with the Bush administration for funding research programmes under the President's Emergency Plan for AIDS Relief.

60 pc of volunteers are women

THE 34 volunteers who have consented to be part of the HIV/AIDS vaccine trials are truly the "unsung heroes". And this time round, about 60 per cent of the volunteers are women.

The first phase of clinical trials are conducted on healthy individuals and Dr Sanjay Mehedale said that these volunteers have been selected after a careful screening process and a written consent.

Elaborating on the profile of the volunteers via video conferencing from Pune, Dr Mehedale said these included social workers, office-goers and persons affected by HIV/AIDS. "Also, they have to be free from diseases such as blood pressure, diabetes, hepatitis B and C," he elaborated.

The volunteers have also been ensured adequate protection in the form of an insurance cover. "During the Phase I trials, there have been very rare instances of a healthy volunteer contracting the disease. We do not think that it would be any different this time too," said Dr N.K. Ganguly of ICMR.

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