HIV VACCINE TRIAL CLINICAL UNIT

该提案描述了HIV疫苗临床试验单位（HVTU）的建立，该单位由哈佛医学院、哈佛公共卫生学院、芬威社区卫生中心和布朗大学的研究人员共同努力。HVTU将开展一项全面综合和协调的计划，对候选艾滋病毒疫苗进行实验室和临床评估，其最终目标是开发一种安全有效的艾滋病毒疫苗，可在世界各地使用。HVTU的综合资源拥有大量多样化的患者人群，可在国内和国际环境中开展I期、II期和III期研究。在国内，研究将在大波士顿和罗得岛地区的人口中进行;在国际上，研究将在博茨瓦纳进行，地点由哈佛公共卫生学院设立。在该奖项的第一年，我们计划在I期研究中招募100名受试者，在II期研究中招募50名受试者，并开始招募多达600名受试者进行III期或“概念测试”试验。我们的方法来设计和进行I期，II期和III期研究的描述。还载有从低风险和高风险类别中征聘、甄选和保留志愿人员的计划，重点是从少数族裔社区征聘个人。还描述了获得受试者真正知情同意的程序。将通过利用博茨瓦纳国内和国际社区咨询委员会寻求社区参与。HVTU的研究者还拥有开展所有必要研究的实验室资源，并具有开发评估免疫原性的创新方法的广泛能力。创新研究的例子包括解决体液免疫，细胞介导的免疫，粘膜免疫和非人灵长类动物的研究的重要领域。作为HIV疫苗试验网络（HVTN）的一个单位，我们的HVTU计划为HVTN的科学领导做出贡献。私家侦探在HVTU，R博士。Dolin被提名为HVTN科学指导委员会成员和I/II期委员会主席。Dolin博士还被HVTN提名为HVTN提出的“概念测试”试验的联合主席。HVTU的共同研究者布鲁斯步行者博士也被HVTN提名为科学指导委员会成员，共同研究者Marian Neutra博士也被提名为粘膜免疫学工作组成员，该工作组将在粘膜免疫领域为HVTN提供科学领导。HVTU的其他合作研究者，包括Max埃塞克斯博士、Joseph Sodroski博士和Norman Letvin博士，预计也将在当地为HVTU提供重要的科学投入，并在国内和国际上为HVTN提供重要的科学投入。

This proposal describes the establishment of an HIV Vaccine Clinical Trial Unit (HVTU) which is a combined effort by investigators at Harvard Medical School, Harvard School of Public Health, Fenway Community Health Center, and Brown University. The HVTU will conduct a fully integrated and coordinated program for the laboratory and clinical evaluation of candidate HIV vaccines, whose ultimate objective is the development of a safe and effective HIV vaccine, which can be used throughout the world. The combined resources of the HVTU have large and diversified patient populations with which to carry out phase I, phase II, and phase III studies in both domestic and international settings. Domestically, the studies will be carried out in populations based in the greater Boston and Rhode Island areas; internationally, studies are to be carried out in Botswana, in a site established by the Harvard School of Public Health. In the first year of the award, we plan to enroll 100 subjects in phase I studies, 50 subjects in phase II studies, and to begin enrollment of up to 600 subjects for a phase III or "test of concept" trial. Descriptions of our approach to the design and conduct of phase I, II, and III studies are included. Plans are also contained for the recruitment, selection, and retention of volunteers from lower and higher risk categories, with emphasis on recruitment of individuals from minority communities. Procedures to obtain genuinely informed consent from subjects are also described. Community involvement will be sought by the utilization of community advisory boards (CABs), both domestically and in the international site in Botswana. The investigators of the HVTU also have the laboratory resources to conduct all required studies, and have extensive capabilities for the development of innovative approaches to assessment of immunogenicity. Examples of innovative studies are included which address important areas of humoral immunity, cell mediated immunity, mucosal immunity, and studies in non-human primates. As a unit in the HIV Vaccine Trials Network (HVTN), our HVTU plans to contribute to scientific leadership of the HVTN. The P.I. of the HVTU, Dr. R. Dolin, has been proposed as a member of the Scientific Steering Committee of the HVTN and chairman of the Phase I/II committee. Dr. Dolin has also been proposed by the HVTN as co-chair of the "test of concept" trial which has been put forward by the HVTN. Dr. Bruce Walker, co-investigator of the HVTU, has also been proposed by the HVTN as a member of the Scientific Steering Committee, and Dr. Marian Neutra, also a co-investigator, has been proposed as a member of the Mucosal Immunology Working Group, which is to provide scientific leadership for the HVTN in the area of mucosal immunity. Other co- investigators of the HVTU, including Drs. Max Essex, Joseph Sodroski, and Norman Letvin, are also anticipated to provide important scientific input, both locally for the HVTU, and nationally and internationally for the HVTN.