Ethical, behavioral, and social prerequisites for conducting HIV vaccine trials in developing countries. The International Collaborative Group on HIV Vaccine Trials.

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

Ethical, behavioral, and social prerequisites for conducting HIV vaccine trials in developing countries. The International Collaborative Group on HIV Vaccine Trials.

Int Conf AIDS. 1993 Jun 6-11;9(1):101 (abstract no. WS-C20-2). Unique Identifier : AIDSLINE MED/93333227
Lurie P; Fernandes ME; Bennett A; Koetsawang S; Coates TJ; Center for AIDS Prevention Studies (CAPS), University of California,; San Francisco.

Abstract: ISSUE: Several investigators are preparing to conduct efficacy trials of HIV vaccines in the developing world. Failure to adequately address the unique ethical, behavioral, and social issues that surround vaccine testing in that setting will jeopardize the success of these trials and future AIDS research in the host nation. DESCRIPTION OF THE PROJECT: 14 investigators from Africa, Asia, North America, and South America reviewed previous experience with trials in developing countries and prepared a paper exploring potential solutions to these issues. CONCLUSIONS: Host country scientists, government officials, and media must be actively involved in all aspects of the trials. Minimum prerequisites for conducting the trial are: 1. Describing local HIV epidemiological and virological characteristics and researching vaccines active against developing world isolates; 2. Establishing and maintaining a technological infrastructure adequate to support the trial; 3. Assessing the feasibility of recruitment in countries where denial of the existence of HIV might exist on an official and/or individual level; 4. Designing methods to obtain informed consent from each individual subject, rather than exclusively from family members or tribal elders; 5. Creating locally appropriate instruments to measure risk behavior; 6. Developing laboratory methods that are readily accessible in the host nation to distinguish between natural and vaccine-induced infection thus preventing discrimination against trial subjects; 7. Seeking convenient dosing schedules for countries in which poor transportation networks may diminish both trial participation and vaccine uptake following approval; 8. Monitoring the social consequences of the trial; 9. Guaranteeing that any vaccine proven effective be made available free of charge to the placebo group and at affordable prices to other citizens of the host country.

Keywords: *Acquired Immunodeficiency Syndrome/EPIDEMIOLOGY *AIDS Vaccines *Bioethics *HIV
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