South-West European HIV Vaccine Clinical Trial Unit

点击翻译按钮获取中文摘要

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: