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Building Capacity in Botswana for the Conduct of HIV Vaccine Trials: Lessons Learned and Regional Implications Authors: Tonya L. Villafana, Peninah Thumbi, Rupert Hambira, Trevor Peter, Richard Leepo, Vladimir Novitsky, Maiteko a Tshireletso Vaccine Initiative Team, Ibou Thior and Max Essex. Issues The HIV strains circulating in the southern African region are essentially all HIV-1 subtype C. Together with high HIV prevalence rate, this reveals the need for the development of prevention interventions and for HIV vaccine designs and trials relevant to regional epidemics. Description Since July 2001 the Botswana-Harvard AIDS Institute Partnership has prepared to conduct HIV vaccine trials in Gaborone, Botswana. A vaccine trial site has been established on the grounds of the largest government hospital. Extensive community consultation has occurred a community advisory board and national vaccine committee have been established, as well as appropriate clinical and laboratory infrastructure. Lessons Learned • Scientific and political issues regarding testing experimental HIV vaccines to address regional specifics must be discussed at all levels. • Potential trial sites must have the ability to adhere to GCP/ICH and GLP, laboratories must be certified and laboratory assays standardized. • Capacity building for appropriate regulatory oversight of clinical trials is necessary, local ethical review boards and drug regulatory units need support and strengthening. • Community education teams and country-specific community education materials are essential to gain widespread support, to dispel myths about vaccine research, and to ensure recruitment of volunteers into studies. • Ethical issues regarding the conduct of trials must be addressed, including age of consent for participation, and ensuring appropriate informed consent for participants. Recommendations Potential HIV vaccine trial sites in southern Africa should ensure that appropriate laboratory and clinical infrastructure, and appropriate regulatory oversight for the conduct of such trials are established. This can be achieved by building national, regional and international partnerships. Regional collaborations can ensure that countries with existing capacity assist with the training of staff and provision of technical support, such as laboratory support for countries that do not have existing infrastructure. |