South-West European HIV Vaccine Clinical Trial Unit

西南部欧洲艾滋病毒疫苗临床试验中心

• 批准号: 8019559
• 负责人: Giuseppe Pantaleo
• 金额: $ 36.82万
• 依托单位: CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8019559
• 关键词: Acquired Immunodeficiency Syndrome; Antiviral Agents; Cellular Immunology; Clinical; Clinical Immunology; Clinical Trials; Clinical Trials Unit; Clinics and Hospitals; Commit; Communicable Diseases; Country; Development; Ethnic Origin; European; Future; HIV; HIV Infections; HIV Vaccine Trials Network; HIV vaccine; HIV-1; Individual; International; Italy; Laboratories; Laboratory Research; Link; Location; Malaria; Monitor; National Institute of Allergy and Infectious Disease; Phase; Population; Procedures; Process; Records; Risk; Solutions; Spain; Switzerland; T cell response; Tuberculosis; United States National Institutes of Health; Universities; Vaccine Clinical Trial; Vaccines; Woman; cohort; experience; improved; pandemic disease; programs; research and development; vaccin protein; vaccine candidate; volunteer

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:

描述(由申请人提供)：有效的艾滋病毒疫苗是最终控制全球艾滋病毒-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对艾滋病毒疫苗进行评估，将其作为选择改进的候选疫苗和开发有效的艾滋病毒疫苗的基本程序。CTU的申请将描述瑞士洛桑的Vaudois中心医院(CHUV)、意大利米兰维塔-萨鲁特大学的Ospedale San Raffaele和西班牙巴塞罗那大学的医院诊所之间的财团。未来的CTU计划加入艾滋病毒疫苗试验网络(HVTN)。 建议成立的职工盟的优势包括： 1.在临床免疫学和传染病方面有高度专业知识的工作人员，并在开展 在艾滋病毒、疟疾和结核病领域进行各种类型疫苗的L/11期临床试验。 2.在属于艾滋病毒感染低风险人群的血清阴性人群中招募妇女的比例很高(-50%)。 3.地点设在西南欧国家，可能招募不同族裔的志愿人员。 4.根据涵盖所有与研究有关的活动的标准作业程序(SOP)进行的临床和实验室活动。 拟议中的CTU的合作伙伴过去曾与多个国际组织开展过合作项目，并正在与多个国际组织开展合作项目，其中包括HVTN、欧洲研究和发展计划、EuroVacc、Obsitif Recherche Vacin SIDA(ORVACS)和NIH艾滋病研究所。未来反恐联盟的合作伙伴关系与在艾滋病毒领域开展活动的当地非政府组织有密切联系。有理由在洛桑设立CTU的行政部门，原因是在管理艾滋病毒疫苗临床试验方面有更多的经验，而且有一个在细胞免疫学领域和监测抗病毒和疫苗诱导的T细胞反应方面经验丰富的经认可的艾滋病毒研究实验室(VIC实验室)。 管理组件：