South-West European HIV Vaccine Clinical Trial Unit

描述（由申请人提供）：有效的HIV疫苗是最终控制全球HIV-1大流行的唯一解决方案。西南欧艾滋病毒疫苗临床试验股（CTU）致力于在临床试验中评价艾滋病毒疫苗，这是选择改良候选疫苗和开发有效艾滋病毒疫苗的一个重要过程。CTU申请将描述瑞士洛桑沃多瓦大学中心医院（CHUV）、意大利米兰维塔-萨卢特大学圣拉斐尔医院和西班牙巴塞罗那大学医院诊所之间的联合体。未来的CTU计划加入HIV疫苗试验网络（HVTN）。 建议成立的职工会工作组的强项包括： 1.工作人员在临床免疫学和传染病方面高度专业化，并在开展 艾滋病毒、疟疾和结核病领域各种类型疫苗的I/II期临床试验。 2.在属于艾滋病毒感染低风险人群的血清反应阴性者队列中招募妇女的比例很高（-50%）。 3.地点在西南欧国家，有可能从各族裔招募志愿人员。 4.根据涵盖所有研究相关活动的标准操作规程（SOP）开展临床和实验室活动。 提议的CTU的合作伙伴过去和现在都与一些国际组织开展合作项目，包括HVTN、欧洲研究和开发计划署、EuroVacc、Objectif Recherche Vaccin SIDA（ORVACS）和NIH艾滋病研究所。未来反恐股的天主教救济会与在艾滋病毒领域开展活动的当地非政府组织有着密切的联系。在洛桑设立反恐股行政部门的理由是，在管理艾滋病毒疫苗临床试验方面有着丰富的经验，而且有一个经认可的艾滋病毒研究实验室（维克实验室），在细胞免疫学领域以及在监测抗病毒和疫苗诱导的T细胞反应方面经验丰富。 行政部门：

DESCRIPTION (provided by applicant): An effective HIV vaccine is the only solution towards the ultimate control of the global HIV-1 pandemic. The South-West European HIV Vaccine Clinical Trial Unit (CTU) is committed to evaluating HIV vaccines in clinical trials as an essential process for the selection of improved vaccine candidates and for the development of an effective HIV vaccine. The CTU application will describe a consortium between the Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland, the Ospedale San Raffaele, Vita- Salute University, Milan, Italy, and the Hospital Clinic, University of Barcelona, Spain. The future CTU plans to affiliate to the HIV Vaccine Trial Network (HVTN). The strengths of the proposed CTU include: 1. Staff highly specialized in clinical immunology and infectious diseases, and experienced in the conduct of Phase l/ll clinical trials with various types of vaccines in the fields of HIV, malaria and tuberculosis. 2. Records of high rates of recruitment of women (-50%) in cohorts of seronegative individuals belonging to low-risk populations for HIV infection. 3. Location in South-Western European countries with potential recruitment of volunteers from various ethnicities. 4. Clinical and laboratory activities performed according to standard operating procedures (SOPs) covering all study-related activities. The partners of the proposed CTU have had past and have ongoing collaborative programs with a number of international organizations including HVTN, European Programs for Research and Development, EuroVacc, Objectif Recherche Vaccin SIDA (ORVACS), and the Division of AIDS NIAID, NIH. The CRS of the future CTU have strong links with local non-governmental organizations operating in the HIV field. The establishment of the administrative component of the CTU in Lausanne is justified by the larger experience in the management of HIV vaccine clinical trials and by the presence of an accredited HIV research laboratory (VIC laboratory) experienced in the field of cellular immunology and in the monitoring of antiviral and vaccine-induced T-cell responses. ADMINISTRATIVE COMPONENT: