IAVI's AIDS vaccine blueprint promotes innovative approaches to evaluating lead candidates
IAVI's flagship publication, the AIDS Vaccine Blueprint 2006: Actions to Strengthen Global Research and Development, was released on August 15 during the International AIDS Conference in Toronto. This biennial publication outlines a series of new scientific and policy initiatives to accelerate the development of an AIDS vaccine through the involvement of industry, building research and clinical trials capacity in developing countries, and a new vaccine development model that will promote the rational design of vaccine candidates as well as an accelerated approach to clinical trials. "The challenges to developing an AIDS vaccine are enormous," said Seth Berkley, Chief Executive Officer and President of IAVI. "We're trying to accelerate every component."
Industry's involvement in the development of an AIDS vaccine is seen by many in the field as imperative since much of the expertise in testing and manufacturing licensed vaccines is found within large pharmaceutical companies. Although several companies are actively engaged in AIDS vaccine research and development, the Blueprint calls for an increased level of commitment.
Another area highlighted in the document is the continued need to enhance the ability of developing countries to conduct AIDS vaccine clinical trials, including the development of networks of excellence for both research and clinical trials in the countries hardest hit by the epidemic. "We need more clinical trial capacity and we also hope that more vaccine research will be done in developing countries," says Pontiano Kaleebu, Assistant Director of the Uganda Virus Research Institute.
The Blueprint also recommends that the AIDS vaccine field implement an accelerated approach to clinical trials that will provide researchers with preliminary data about a candidate's efficacy earlier in development. The proposal would entail running several Phase II trials involving around 500 volunteers in parallel, rather than a single Phase IIb test-of-concept trial with up to 3000 volunteers. Only those candidates that show some degree of efficacy and improve upon the best current products would then go into more advanced trials.
All articles written by Kristen Jill Kresge