Targeted Genetics, Columbus Children’s Research Institute, IAVI Announce Clinical Trials of Single-Injection AIDS VaccineTargeted Genetics, the Columbus Children's Research Institute and the International AIDS Vaccine Initiative on Tuesday announced that they have begun a small-scale clinical trial of a new HIV vaccine, the Seattle Times reports (Timmerman, Seattle Times, 12/9). Unlike many vaccines currently in clinical trials, the vaccine candidate, called tgAAC09, could potentially be a single-shot vaccine, which would be particularly useful in developing countries, according to a Targeted Genetics release (Targeted Genetics release, 12/9). In addition, animal trials have shown that tgAAC09 can stimulate a "double-barreled" immune response, meaning that it stimulates both an antibody and a cell-mediated response to HIV, the Times reports (Seattle Times, 12/9). "Based on how this vaccine performed in animal studies, we are hopeful that in human trials it will demonstrate an ability to protect people from contracting HIV/AIDS," Dr. Philip Johnson, president of CCRI, who developed the vaccine with Targeted Genetics, said, adding, "Results to date demonstrate safety and suggest the ability to elicit robust immune responses after a single injection."
The trial, which will be conducted at the Centre Hospitalier Universitaire Saint-Pierre in Brussels, Belgium, will test the safety and immune response of the vaccine in 50 male and female volunteers (Targeted Genetics release, 12/9). If the vaccine is shown to be safe, it may advance to larger clinical trials, which could involve thousands of people in high-risk groups, such as sex workers. However, even if the vaccine is successful in clinical trials, the earliest it would be available is 2008, Dr. Wayne Koff, senior vice president of research and development for IAVI, said. IAVI has said that it will finance further trials of the vaccine if the results are promising, Stewart Parker, CEO of Targeted Genetics, said. Under a deal with IAVI, Targeted Genetics would maintain intellectual property rights to the vaccine, promising to sell it at a low price in the developing world and maintaining the rights to sell it in "potentially profitable" markets in Europe and the United States, the Times reports (Seattle Times, 12/9).