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Candidate HIV/AIDS vaccines: lessons learned from the World's first phase III efficacy trials

Source: AIDS 2003; 17(2):147-156

Authors: Donald P. Francis; William L. Heyward; Vladimir Popovic; Patti Orozco-Cronin; Karin Orelind; Carolyn Gee; Adrian Hirsch; Tina Ippolito; Aimee Luck; Michael Longhi; Vineeta Gulati; Nathan Winslow; Marc Gurwith; Faruk Sinangil; Phillip W. Berman

Abstract: The world's first HIV vaccine efficacy trials will conclude in 2003. Vaccines are developed and manufactured by industry. However, this task cannot be accomplished by industry alone. To achieve the goal of providing a safe and effective HIV vaccine for those in need, industry, investors/funders, clinical and research partners-a collaboration of both public and private institutions are needed. VaxGen Inc., as the industry partner in this multi-partner collaboration, has learned many valuable lessons that can be applied in the future to support the successful development of an HIV vaccine. The results of the two efficacy trials of candidate HIV-1 vaccines will be available during 2003. The first, the AIDSVAX B/B trial, was started in 1998 in the USA, Canada, Puerto Rico and the Netherlands. This trial concluded in late 2002 and initial efficacy results were recently made available. The second, the AIDSVAX B/E trial, was started in Bangkok, Thailand in 1999 and will similarly have initial efficacy results available in late 2003. This paper reviewed the lessons that have been learned through the experience of conducting the first phase III HIV vaccine efficacy trials.

 
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