February 8, 2005
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).
"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).