The Hindu : Front Page : AIDS vaccine likely in eight years: Minister

Online edition of India's National Newspaper
Tuesday, Feb 08, 2005

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Front Page

AIDS vaccine likely in eight years: Minister

By Aarti Dhar

NEW DELHI, FEB. 7. India today began human clinical trial of an investigational vaccine designed to prevent Human Immunodeficiency Virus (HIV) infection and Acquired Immuno-Deficiency Syndrome (AIDS). The first preventive AIDS vaccine trial is being conducted at the Pune-based National AIDS Research Institute (NARI) and, if successful, a vaccine against the disease would be available within eight years.

Announcing this here today at a press conference, the Union Health and Family Welfare Minister, Anbumani Ramadoss, said the trial was being carried out by the Indian Council of Medical Research (ICMR) and the national AIDS Control Organisation (NACO) and the International AIDS Vaccine Initiative, a non-profit organisation working on AIDS prevention.

Volunteer injected

The trial involves testing a vaccine named tgAAC09 (recombinant adeno-associated viral vector (rAAV). A `volunteer' was injected the first vaccine as Mr. Ramadoss and the Minister of State for Science and Technology, Kapil Sibal, announced the beginning of the clinical trial. Targeted Genetics Corp., a Seattle-based biotechnology company, and Columbus Children's Research Institute in Ohio have designed the vaccine in partnership with IAVI.

The vaccine candidate tgAAC09 is designed after sub-type C of HIV, a type that accounts for the most infections worldwide and is prevalent in many developing countries, including India and South Africa. The vaccine is designed so that it cannot cause HIV infection or AIDS and consists of an artificially made copy of a portion of HIV's genetic material.

According to N.K. Ganguly, Director-General of ICMR, the trial heralds the Government's commitment to combating the AIDS epidemic. "Our country is an emerging global leader in biomedical research. With this first trial, Indian scientists are making an important contribution that will bring the world a step closer to an AIDS vaccine."

Safety evaluation

The phase-I vaccine trial is the first stage of human testing and the primary purpose is to evaluate safety. The trial will take roughly 15 months to complete and will enrol 30 volunteers, men and women, who are in good health and not infected with HIV. The trial in India is part of multi-country phase-1 trial of tgAAC09 that is also under way in Europe where researchers in Germany and Belgium are testing the vaccine candidate.

The regulatory approval to test tgAAC09 in India was granted by the Drugs Controller-General, the Steering Committee of the Health Ministry, the NARI Ethic Committee, the Genetic Engineering Approval Committee, and the National Ethics Committee. The vaccine showed encouraging results in animals, protecting some of them from developing AIDS after they became infected with an HIV-like virus.

During the trial, some volunteers receive an injection of tgAAC09 into the upper arm while others receive an inactive substance called a placebo. Neither the volunteers nor the people working with them will know who received tgAAC09 and who received the placebo until the study finishes. Volunteers return to the trial site frequently for checkups, and samples of their blood are analysed for safety. In addition, blood samples will be analysed to collect preliminary data on whether the vaccine candidate elicits immune responses that may play a role in preventing HIV infection or AIDS. The trial is comparing a low, medium and high vaccine dose.

Mr. Sibal said the volunteers have given their consent in writing before participating in the trial and they are free to leave the trial at any time for any reason. While the volunteers are covered under the general medical insurance — a practice initiated by India — the study team will be responsible for their trial-related health problems for five years and after that NACO and ICMR will look after their health. The personal information regarding each volunteer is held in strict confidence.

The $20-million programme is being funded by eight countries, the European Union, the World Bank and several individuals. More than 20 years after HIV/AIDS was identified, new infections occur worldwide at the rate of 14,000 everyday.

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