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ICMR, NACO, IAVI initiate phase I trials on 2nd AIDS vaccine, first vaccine trial to end by 2007
Y.V. Phani Raj, Hyderabad | Tuesday, February 28, 2006, 08:00 Hrs  [IST]

The Indian Council of Medical Research (ICMR), the National AIDS Control Organization (NACO) and the International AIDS Vaccine Initiative (IAVI) launched India's second preventive AIDS vaccine trial during early February, 2006.

The phase I AIDS vaccine trial is to be conducted at the Tuberculosis Research Centre (TRC) in Chennai. The investigational vaccine candidate, TBC-M4, is designed as a preventive vaccine to protect people who are not infected with HIV from contracting HIV/AIDS. It consists of a recombinant modified vaccinia ankara (MVA) targeting HIV-1 subtype C, the most predominant HIV subtype in India. YRG Care, a premier non-profit HIV referral centre, is also a key partner responsible for community mobilisation and recruitment of volunteers.

The International AIDS Vaccine Initiative (IAVI) and biotechnology firm Therion Biologics Corporation (Cambridge, Massachusetts, USA) collaborated on the development of the AIDS vaccine candidate utilising MVA vector technology. Therion, with the assistance of Dr Sekhar Chakrabarti, an Indian scientist from the National Institute of Cholera and Enteric Diseases, Kolkata, designed the candidate and manufactured doses of it for initial clinical trials.

The Chennai study is a small-scale trial, with a primary aim to evaluate the safety of the product. Goals also include gathering preliminary data on the ability of the vaccine candidate to stimulate immune responses against HIV/AIDS.

India's first-ever human clinical trial of an investigational vaccine candidate designed to prevent HIV/AIDS began on February 7, 2005. The trial is being conducted through a partnership between the Government of India through the Indian Council of Medical Research (ICMR) and the National AIDS Control Organization (NACO) and the non-profit International AIDS Vaccine Initiative (IAVI).

The phase I trial is testing a vaccine candidate named tgAAC09 (recombinant adeno-associated viral vector, rAAV). Targeted Genetics Corp., a Seattle-based biotechnology company, and Columbus Children's Research Institute (CCRI) in Ohio designed the vaccine candidate in partnership with IAVI. The vaccine candidate tgAAC09 is modelled after subtype C of HIV, the subtype that accounts for the most infections worldwide and is prevalent in many developing countries, including India and South Africa. The candidate vaccine tgAAC09 is designed so that it cannot cause HIV infection or AIDS; it consists of an artificially made copy of a portion of HIV's genetic material.

The phase I AAV trial at National AIDS Research Institute (NARI), Pune, India is part of a multi-country trial, including sites in Belgium and Germany. The recruitment and vaccination of the planned number of volunteers for the A001 AAV (tgAAC09) phase I trial has been completed. The results from this phase I trial will be analysed jointly at the end of the trial in early 2007, probably by February, according to IAVI officials.

In December 2000, the Ministry of Health and Family Welfare, Government of India and the Indian Council of Medical Research (ICMR) signed a Memorandum of Understanding with International AIDS Vaccine Initiative (IAVI) to develop a preventive, safe, effective and accessible AIDS vaccine.

The Government of India and IAVI have adopted a multiple AIDS vaccine candidate development strategy. There is scientific merit in considering this approach as it would allow the testing of several vaccine candidates in parallel rather than sequentially to ensure that an effective AIDS vaccine is available at the earliest.

More than 20 years after HIV/AIDS was identified, new infections are occurring worldwide at the rate of 14,000 every day. In 2005, nearly five million people became infected with HIV, according to statistics recently released by the Joint United Nations Program on HIV/AIDS (UNAIDS).

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