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中文摘要
翻译
疫苗研究中心(VRC)临床试验计划(CTP)项目的目的是为志愿者筛选涉及研究药物管理的方案,收集人体样本,如血液、粘膜分泌物、皮肤拭子、皮肤活检或体液,在某些情况下进行放射成像和临床评估,以支持实验室研究,并验证用于评估临床试验免疫原性结果的研究分析。这些样本和数据被实验室研究人员用于开发针对艾滋病毒和其他新出现的传染病的疫苗和单抗,研究与传染病有关的免疫的相关性,以及与开发和/或验证免疫学分析有关的实验室工作。为了进行研究,有时需要获得比简单的静脉切割术安全获得的更多的血浆或单个核细胞。这些成分可以通过在NIH临床中心输血医学部(DTM)进行的分离程序安全地获得。
英文摘要
The purpose of this Vaccine Research Center (VRC) Clinical Trials Program (CTP) project is to screen volunteers for protocols that involve the administration of investigational agents and to collect human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or body fluids, and in some circumstances perform radiographic imaging and clinical evaluations, to support laboratory research studies and to validate research assays used in evaluation of clinical trials immunogenicity results. These samples and data are used by laboratory researchers in their work on the development of vaccines and monoclonal antibodies targeting HIV and other emerging infectious diseases, to study the correlates of immunity related to infectious diseases, and in laboratory work related to the development and/or validation of immunological assays. In order to carry out research studies, it is sometimes necessary to obtain larger quantities of plasma or mononuclear cells than can be safely obtained by simple phlebotomy. These components can be safely obtained using apheresis procedures, which are performed in the NIH Clinical Center Department of Transfusion Medicine (DTM).
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Biodefense and Emerging Infectious Disease Vaccine Studies
Biodefense and Emerging Infectious Disease Monoclonal Antibody Studies
Sample Collection and General Screening Protocols
Sample Collection and General Screening Protocols
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