India to conduct clinical trails for HIV vaccine

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India to conduct clinical trails for HIV vaccine

India is preparing to go in for Phase-I clinical trials in March next year for a

preventive HIV vaccine developed by a scientist of the National Institute of

Cholera and Enteric Diseases (NICED), Kolkata, in collaboration with a U.S. -

based biotechnology company.

With this, India would join the global effort in finding a vaccine that would

prevent healty, unaffected people from being infected with HIV. Trials are on

in parts of the world with no breakthrough yet. India is estimated to have

about four million people affected with HIV at the end of 2002.

The Phase-I trial, involving administration of the MVA (Modified Vaccinia

Ankara) HIV-1 subtype C vaccine for the first time to humans in India would be

conducted with 13 healthy volunteers in the age group of 18-50 to determine the

efficacy of the vaccine. It would be conducted at the National AIDS Research

Institute (NARI) Pune, under a tripartite agreement between the National AIDS

Control Organisation (NACO), the Indian Council of Medical Research (ICMR) and

the International AIDS Vaccine Initiative (IAVI). Other areas would later be

Chennai and the north east.

The Union Government would control the use of the vaccine if and when developed.

Three vaccine manufacturers have been shortlisted, though the Phase-I trial

vaccine has been manufactured by Therion. About Rs.17 crores has been invested

by ICMR so far. IAVI is looking at an investment of $100 million till the

marketing of a vaccine.

The Phase-I would determine the safety, immunogenicity (ability to induce strong

immune responses in the person to fight HIV) of the intramuscular vaccine,

preliminary dose requirement and schedules for immunisation. This phase is

expected to last two years.

Participating in a media workshop here on Friday (New Delhi), the

Director-General of ICMR, N.K. Ganguli, and NACO experts expressed the

confidence that the ethical and regulatory clearances on safety and toxicology

and pre-clinical studies will come before March.

There was no clarity, however, on the norm that a vaccine developed in another

country - in this case the U.S. - should first undergo Phase-I clinical trial in

the country of origin.

Although the India-specific vaccine has been developed with the involvement of

the scientist, Shekhar Chakravorty, of NICED and the U.S. Biotech Company,

Therion Biologic Corporation in the U.S., there has been no Phase-I clinical

trials with this vaccine in that country.

According to Mark Chataway of the IAVI, all HIV laboratory research in vaccine

development has to be uniform for global acceptability, though bound by the

regulatory requirements of each country.

He hoped the Drugs Controller of India would accept the validity of the ongoing

preclinical and toxicology studies on animals (mice) under way at the Therion

Corporation.

The current status of the trial in India is that a new vaccine trial centre and

immunology dedicated laboratory and staff is being set up at NARI. Efforts are

on to enrol volunteers who are likely to be from groups of high-risk sex

workers, truck drivers, health care workers and adolescents. The scientists

said there would be sufficient safeguards for the volunteers to cover risks.

Source:THE HINDU, Sunday,October 12,2003,Page No.8,Madurai Edition)

_____________________

Yours in Global Concern

A.SANKAR

Executive Director

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