Assessment and preparation of potential study populations suitable for conducting HIV preventive vaccine efficacy trials.

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

Assessment and preparation of potential study populations suitable for conducting HIV preventive vaccine efficacy trials.

Int Conf AIDS. 1993 Jun 6-11;9(1):101 (abstract no. WS-C20-6). Unique Identifier : AIDSLINE MED/93333226
Heyward W; Osmanov S; Heymann D; Esparza J; Global Programme on AIDS, World Health Organization, Geneva,; Switzerland.

Abstract: OBJECTIVES: To assess existing cohorts for potential HIV vaccine trials in developing countries, especially in the four countries with WHO-sponsored National Plans for HIV/AIDS Vaccine Research, Development and Evaluation (Brazil, Rwanda, Thailand, and Uganda). METHODS: Existing cohorts were assessed by WHO teams visiting the countries, through extensive discussions with national investigators and their international collaborators, and by review of available data. RESULTS: Different potential populations were identified as suitable for HIV preventive vaccine trials (community cohorts, students, military, company employees, STD clinic patients, IVDUs, prostitutes, homo/bi-sexual men, discordant couples). However, these groups vary considerably in risk of HIV infection (HIV incidence), population size, and stability over time, factors which are of critical importance in determining vaccine safety and efficacy. Although some groups are more conductive than others for efficient vaccine trials, no group is without potential obstacles which may significantly interfere with the primary objective of determining vaccine efficacy. CONCLUSIONS: The following studies are being conducted with the assistance of WHO to prepare existing cohorts: (1) studies on HIV incidence, including considerations of how HIV incidence will change with time; (2) effects of standard interventions on HIV incidence; (3) behavioural studies to determine factors affecting participation and follow-up, and how trial participation will affect behaviour; and (4) expansion of existing cohorts and establishment of new cohorts. In this regard, emphasis is being placed on establishing and characterizing open or "dynamic" cohorts (in which participants are coming and leaving the cohort during the follow-up period), as compared to closed or "fixed" cohorts (in which participants are identified at the start with no new entries after the onset of follow-up).

Keywords: *Acquired Immunodeficiency Syndrome/PREVENTION & CONTROL *AIDS Vaccines/THERAPEUTIC USE *HIV *HIV Infections/PREVENTION & CONTROL
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M93B5821

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