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  1. 1

    Establishment of WHO-sponsored field sites for HIV vaccine evaluation in developing countries.

    Heyward WL; Osmanov S; Esparza J


    Probably 90% of the estimated 14-15 million people living with HIV infection worldwide reside in developing countries. With the global HIV pandemic disproportionately affecting people in the developing world, developing countries need to be involved in all stages of vaccine development, from initial research to the approval and licensing of a product to the public. During 1991, World Health Organization (WHO) teams visited 14 developing countries in Africa, Asia, and Latin America to assess their capacity and interest in conducting HIV vaccine trials. The assessments considered the epidemiological aspects of the epidemic in the country, the clinical and laboratory infrastructures available, the logistical and operational aspects of conducting vaccine-related research, and the community and political support for HIV vaccine trials. In 1992, the WHO Steering Committee on Vaccine Development announced that it would work with the national authorities and scientists of Brazil, Rwanda, Thailand, and Uganda to develop and implement comprehensive plans for HIV vaccine research, development, and evaluation. The activities in Rwanda, however, were suspended due to recent genocide and related civil unrest. National plans have been developed with WHO assistance in the other three countries. HIV isolation and characterization and epidemiologic, clinical, and social and behavioral studies are discussed as essential for the preparation of the field sites for vaccine trials.
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  2. 2

    HIV vaccine trials in developing countries. The UNAIDS perspective.

    Heyward WL; Osmanov S; Esparza J

    [Unpublished] 1996. Presented at the 11th International Conference on AIDS, Vancouver, Canada, July 7-12, 1996. 12 p.

    Even though most people agree that a safe, effective, and available HIV preventive vaccine is needed, few agree on the characteristics of such a vaccine and how to proceed. The debate revolves around the uncertainties of the immunological correlates of protection, the antigenic significance of HIV genetic variability on vaccine-induced protection, and the biological variability of HIV and the meaning of animal protection experiments with experimental vaccines. The decision to move towards efficacy trials depends on feasibility, the science, and the vaccine. One important feasibility factor is availability of a well-characterized population with a high incidence of HIV infection, despite available interventions. A scientific factor to consider is HIV characterization (genetic variability, HIV subtypes). Current safety and immunogenicity data from phase I and II trials and ability of the vaccine to induce neutralizing antibodies and CTLs comprise some vaccine factors. Researchers have found high-risk populations willing to participate in phase III trials in Thailand. UNAIDS proposes a balanced approach strategy of conducting efficacy trials with vaccine candidates which have met minimal requirements while also conducting basic research to acquire more information on what is needed for a protective immune response. The efficacy trials may reveal some information related to such a response. Final decisions and responsibilities lie with national governments and institutions. UNAIDS is prepared to help countries in their decision making efforts. Extensive preparation and international collaboration and coordination are needed for phase III efficacy trials. Developing countries (e.g., Thailand) themselves must participate in HIV vaccine development, since most HIV infections are in these countries and these countries have the most to gain. Genetic variability of HIV and different co-factors and routes of HIV transmission indicate the need to conduct multiple efficacy trials in different areas worldwide.
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  3. 3

    UNDP in India: a retrospective. Special report: India.

    Godwin P

    AIDS ANALYSIS ASIA. 1996 Nov; 2(6):9, 15.

    This article reviews the purpose and achievements of India's UNDP Regional HIV Project, which ended in June 1996. To reduce vulnerability to HIV, the project concentrated on: 1) identifying the reciprocal role of socioeconomic factors in HIV transmission, 2) strengthening the role of nongovernmental organizations as mediators between communities and the government, 3) fostering the creation of multisectoral policies and procedures developed to elicit increased private sector response to HIV, and 4) promoting development of an enabling environment characterized by appropriate legal and ethical responses to the epidemic. Thus, the project published a series of pertinent publications and supported studies and workshops. The principles guiding decisions about which activities to fund included: 1) minimalizing management costs, 2) mobilization of technical assistance, 3) capacity building by encouraging innovation, and 4) flexibility. The project was successful in validating the likely scope and scale of the socioeconomic impact of HIV, in complementing and supplementing the work of other agencies, and in legitimizing UNDP's role as the agency that understands and can support socioeconomic and multisectoral responses to HIV (which, in turn, defines UNDP's role within UNAIDS).
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