WHO/UNAIDS convene meeting on AIDS vaccine clinical trial design
The World Health Organization (WHO) and the United Nations Joint Programme on HIV/AIDS (UNAIDS) recently sponsored a technical consultation with experts in the AIDS vaccine field to discuss the design and use of Phase IIb "test of concept" trials in evaluating AIDS vaccine candidates and their implications for approval and licensure (seeVAX September 2005 Primer on Understanding Test-of-Concept Trials).
This meeting, hosted by IAVI, was held from January 31 to February 2 in New York City and brought together a diverse range of organizations to consider both the design of test of concept trials and how they should be viewed by vaccine approval agencies in developing countries. Attendees included representatives from the Botswana Harvard AIDS Institute Partnership, Medical Research Council of South Africa, Chinese Center for Disease Control and Prevention, Project San Francisco in Rwanda, HIV Vaccine Trials Network (HVTN), US National Institutes of Health (NIH), US Centers for Disease Control and Prevention, US Food and Drug Administration, IAVI, Johns Hopkins University, as well as other representatives from India, Thailand, and Zambia. The recommendations of this group will be presented as a position paper to the WHO/UNAIDS Vaccine Advisory Committee and will be used to help these organizations develop a set of guidelines on test of concept trials for AIDS vaccines.