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

B. Sheets, P. Folb, D. Wassenar, N. Barsdorf, R. MacKlin, J. Wasserheit, M. P. Kieny, C. Hankins, S. Osmanov, C. Touré, R. Hutubessy

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalAIDS
Volume21
Issue number14
DOIs
StatePublished - Sep 2007
Externally publishedYes

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Botswana
AIDS Vaccines
Referral and Consultation
Clinical Trials
Southern Africa
Eastern Africa
United Nations
Advisory Committees
Licensure
Ethics
Patient Selection
Developing Countries
Acquired Immunodeficiency Syndrome
Joints
HIV

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

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. / Sheets, B.; Folb, P.; Wassenar, D.; Barsdorf, N.; MacKlin, R.; Wasserheit, J.; Kieny, M. P.; Hankins, C.; Osmanov, S.; Touré, C.; Hutubessy, R.

In: AIDS, Vol. 21, No. 14, 09.2007.

Research output: Contribution to journalArticle

Sheets, B, Folb, P, Wassenar, D, Barsdorf, N, MacKlin, R, Wasserheit, J, Kieny, MP, Hankins, C, Osmanov, S, Touré, C & Hutubessy, R 2007, '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', AIDS, vol. 21, no. 14. https://doi.org/10.1097/QAD.0b013e3282f086f5
Sheets, B. ; Folb, P. ; Wassenar, D. ; Barsdorf, N. ; MacKlin, R. ; Wasserheit, J. ; Kieny, M. P. ; Hankins, C. ; Osmanov, S. ; Touré, C. ; Hutubessy, R. / 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. In: AIDS. 2007 ; Vol. 21, No. 14.
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