Leadership Group for a Global HIV Vaccine Clinical Trials Network

项目摘要：本提案描述了一个多学科、多学科、 国际艾滋病毒疫苗试验网络（HVTN）。HVTN的组成部分包括领导层 协调和运营中心（L。Corey，PI; J.N. Wasserdam，Director），a Statistical and Data 管理中心（S.G. Self，PI）和网络实验室程序（M. J. McElrath，PI）。 使命是提供一个客观和透明的平台，以评估候选艾滋病毒疫苗， 在全球范围内预防成人和青少年感染艾滋病毒。为了实现这一目标，HVTN将 进行候选HIV疫苗和佐剂的安全性、免疫原性和有效性试验; 候选疫苗的直接比较;制定实验室和统计方法， 保护的相关性;设计试验以评估降低HIV病毒设定点的疫苗对HIV的影响 在特殊人群（如青少年）中进行候选疫苗试验， 静脉注射吸毒者;制定社区教育计划，以提高入学率和保留率， 艾滋病毒感染高危人群;制定标准化的降低风险咨询方法;以及 与其他NIH网络、联邦机构和非政府研究组织合作， 以最佳效率和成本效益推进最高质量的艾滋病毒疫苗研究。 相关性：艾滋病毒流行病的发展，以及国际、政治和经济损失， 为有效的预防艾滋病毒疫苗提供令人信服的理由。虽然其他预防策略提供 在减缓艾滋病毒传播速度方面取得了重要进展，无症状感染的高发病率持续存在， 艾滋病毒感染者需要研制有效的疫苗。为了减少 一个强有力的综合实验室和临床试验网络是这一全球大流行病传播的必要推动力 艾滋病疫苗领域。

Project Summary: This proposal describes the organization of a comprehesive, multidisciplinary, international HIV Vaccine Trials Network (HVTN). Components of the HVTN include a Leadership Coordinating and Operations Center (L. Corey, PI; J.N.Wasserheit, Director), a Statistical and Data Management Center (S.G. Self, PI),and a Network Laboratory Program (M.J.McElrath, PI).The HVTN's mission is to provide an objective and transparent platform to evaluate candidate HIV vaccines for the prevention of HIV infection in adult and adolescent populations globally. To achieve this, the HVTN will perform safety, immunogenicity, and efficacy trials of candidate HIV vaccines and adjuvants; conduct head- to-head comparisons of candidate vaccines; develop laboratory and statistical approaches to define potential correlates of protection; design trials to estimate the effects of vaccines that reduce HIV viral set point on HIV transmission; conduct trials of candidate vaccines in special populations, such as adolescents and intravenous drug users; develop a community education program to enhance the enrollment and retention of populations at high risk for HIV acquisition; develop standardized risk reduction counseling methods; and collaborate with other NIH networks, federal agencies and non-governmental research organizations to advance the highest quality HIV vaccine research, with optimal efficiency and cost effectiveness. Relevance: The progression of the HIV epidemic, as well as the international, political, and economic toll, make a compelling case for an effective preventive HIV vaccine. While other prevention strategies offer important advances in slowing the rate of spread of HIV, the high incidence of asymptomatic persistently infected HIV-infected persons requires the development of an effective vaccine. In order to reduce the spread of this global pandemic a robust integrated laboratory and clinical trials network is a necessary driver of the HIV vaccine field.