Preparation for efficacy trials of HIV candidate vaccines: the role of the World Health Organization.

Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.

Preparation for efficacy trials of HIV candidate vaccines: the role of the World Health Organization.

Int Conf AIDS. 1993 Jun 6-11;9(1):101 (abstract no. WS-C20-1). Unique Identifier : AIDSLINE MED/93333230
Esparza J; Osmanov S; Heymann D; Global Programme on AIDS, World Health Organization, Geneva,; Switzerland.

Abstract: OBJECTIVES: To assist national authorities and scientists in developing countries to strengthen the infrastructure that will be required for the conduct of vaccine trials with the highest ethical and scientific standards. METHODS: WHO-sponsored National Plans for HIV/AIDS Vaccine Research, Development and Evaluation" were prepared by national authorities and scientists from Brazil, Rwanda, Thailand and Uganda, with the assistance of WHO. RESULTS: The Plans contain specific details for the selection of participating national investigators and institutions, interaction with other international AIDS research programmes, infrastructure strengthening and training, and promotion of priority HIV vaccine-related research. In preparation for future large-scale efficacy trials of preventive HIV candidate vaccines, research projects in the following areas are being supported by WHO in the four countries: (1) Virus isolation and characterization (as part of the "WHO Network for HIV Isolation and Characterization"), to select and/or design appropriate candidate vaccines for testing; (2) Epidemiological studies, to establish or adapt cohort and to determine HIV incidence under planned study conditions; (3) Clinical research, to conduct repeat Phase I/II trials of selected candidate vaccines to further assess safety and immunogenicity at the site; and (4) Social and behavioural studies, to address issues such as motivation to participate in trials, counselling and informed consent. CONCLUSIONS: Multiple efficacy trials of HIV preventive vaccines, both in developed and developing countries, will be required to answer different questions related to vaccine efficacy, and appropriate study populations for such trials should be prepared now.

Keywords: *Acquired Immunodeficiency Syndrome/PREVENTION & CONTROL *AIDS Vaccines/TOXICITY *AIDS Vaccines/THERAPEUTIC USE *HIV Infections/PREVENTION & CONTROL
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