Executive summary and recommendations from WHO/UNAIDS and AAVP consultation on: 'The inclusion of adolescents in HIV vaccine trials', 16-18 March 2006 in Gaborone, Botswana.

This report summarizes the discussions and recommendations from a consultation held in Gaborone, Botswana (16-19 March 2006), organized by the joint World Health Organization (WHO)/United Nations Programme on HIV/AIDS (UNAIDS) HIV Vaccine Initiative (HVI) and the African AIDS Vaccine Programme (AAVP). The consultation considered key challenges and strategies in enrolling adolescents into HIV vaccine clinical trials, relevant to developing countries, in particular in eastern and southern Africa. Approaches were identified that might address and resolve country-specific challenges related to scientific, legal, ethical, regulatory and community aspects of the involvement of adolescents in HIV vaccine trials. This executive summary is formulated for a broader dissemination of the outcomes of the meeting to the general clinical, scientific and regulatory community involved in the review, approval and monitoring of clinical trials and potential licensing of HIV vaccine candidates. Four major topics were discussed and recommendations developed with regard to: (i) criteria for products selection and clinical trial design; (ii) ethical and legal issues; (iii) community acceptance and participation; and (iv) regulatory considerations. The recommendations of this meeting were further discussed and endorsed by the WHO/UNAIDS HIV Vaccine Advisory Committee.