India Begins Phase I Clinical Trial for HIV Vaccine Targeting C Strain

Indian Health Minister Anbumani Ramadoss on Monday announced that the country has begun its first-ever Phase I clinical trial of an HIV vaccine, Reuters reports (Katyal, Reuters, 2/7). The trial, which is being conducted by the Indian Council of Medical Research and the International AIDS Vaccine Initiative, is testing the vaccine candidate called tgAAC09, which was developed by Seattle-based Targeted Genetics and the Columbus Children's Research Institute in Ohio (George, AP/Seattle Post-Intelligencer, 2/7). Unlike many vaccines currently in clinical trials, tgAAC09 potentially could be a single-shot vaccine, which would be useful in developing countries. In addition, animal trials have shown that the vaccine candidate can stimulate a "double-barreled" immune response, meaning that it stimulates both an antibody and a cell-mediated response to HIV (Kaiser Daily HIV/AIDS Report, 12/10/03). The vaccine focuses on HIV subtype C, which is the most common strain of the virus in India (AFP/Yahoo! News, 2/7). The Indian trial is part of a multicountry Phase I trail of tgAAC09, which already has started in Europe with German and Belgian researchers testing the vaccine in partnership with IAVI, according to an IAVI release (IAVI release, 2/7). IAVI beginning in March 2001 provided $3 million over 18 months to the Indian government to fund HIV vaccine development efforts (Kaiser Daily HIV/AIDS Report, 3/22/01). More than five million HIV-positive people live in India, according to the AP/Post-Intelligencer.

Trial Details
The trial, which is expected to take about 15 months to complete, will test the vaccine on 30 male and female volunteers ages 18 to 45 who are HIV-negative and do not have any other significant illnesses, according to researchers, the AP/Post-Intelligencer reports (AP/Seattle Post-Intelligencer, 2/7). The trial will take place at the National AIDS Research Institute in Pune, India (Kashyap, Times of India, 2/7). ICMR Director N.K. Ganguly said that the candidate vaccine might stimulate an immune system response that could protect volunteers from potential HIV infection, BBC News reports. "The volunteers have been made aware of the risks involved, they have been counseled and their health status will be monitored all the time," Ganguly said (BBC News, 2/7). The European trial -- conducted at the Centre Hospitalier Universitaire Saint-Pierre in Brussels, Belgium -- is testing the safety and immune response of the vaccine in 50 male and female volunteers. If the vaccine is shown to be safe, it might advance to larger clinical trials, which could involve thousands of people at high risk of contracting HIV, such as commercial sex workers (Kaiser Daily HIV/AIDS Report, 12/10/03). Targeted Genetics expects to report data from the European trial in the first half of 2005, according to a Targeted Genetics release (Targeted Genetics release, 2/7).

Reaction
"We've started the first phase of clinical trials, but 85% of our focus is still going to be on prevention," Ramadoss said at a press conference, adding, "Developing a vaccine to prevent AIDS is one of the most difficult scientific challenges of our time. It is also one of the most urgent health needs" (Reuters, 2/7). Seth Berkley, IAVI president and CEO, said that conducting a vaccine clinical trial in India is "essential" because of the country's advanced biomedical research facilities and its "strong" pharmaceutical industry, according to the AP/Post-Intelligencer. He added that the search for an HIV vaccine "is a marathon which requires the commitment of the world's political leaders to make the best science and the best facilities available" (AP/Seattle Post-Intelligencer, 2/7).

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