Scientific considerations for the regulation and clinical evaluation of HIV/AIDS preventive vaccines: report from a WHO-UNAIDS Consultation 13-15 March 2001, Geneva, Switzerland.

The consultation was jointly organized by the WHO-UNAIDS HIV Vaccine Initiative and the Quality Assurance and Safety of Biologicals Team of the World Health Organization (WHO). Thirty-four experts from 16 developed and developing countries attended the meeting, bringing together expertise from academic institutions, clinical trial centres, national and international regulatory authorities. Representatives of major pharmaceutical companies were also invited. The primary objective of the meeting was to identify gaps that need to be addressed from regulatory perspective to ensure appropriate progress of HIV vaccine development from basic research to human trials, licensing and future application, with a special focus on needs of developing countries. As a result of discussions, the following priority needs were identified and recommendations were made in order to establish an appropriate regulatory framework for the development and evaluation of preventive HIV/AIDS vaccines, which were divided in two main areas: (a) standardization and control of candidate HIV/AIDS vaccines, and (b) approaches to the conduct of clinical trials of candidate HIV/AIDS vaccines.