Sample Collection and General Screening Protocols

样品采集和一般筛选方案

• 批准号: 10275372
• 负责人: Julie E. Ledgerwood
• 金额: $ 181.11万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10275372
• 关键词: Biological Assay; Biopsy; Blood; Blood Component Removal; Body Fluids; Cells; Clinical Trials; Communicable Diseases; Data; Development; Diagnostic radiologic examination; Disease; Eligibility Determination; Emerging Communicable Diseases; HIV; Human; Image Analysis; Immune; Immune response; Immunity; Immunology procedure; Investigation; Laboratories; Laboratory Research; Measures; Methods; Monoclonal Antibodies; Mononuclear; Mucous Membrane; Pathogenesis; Plasma; Procedures; Protocols documentation; Research; Research Personnel; Sampling; Severity of illness; Skin; Specimen; Swab; Tissues; United States National Institutes of Health; Vaccinated; Vaccine Clinical Trial; Vaccine Research; Vaccines; Validation; Venous blood sampling; Virus Diseases; Work; clinical center; experience; healthy volunteer; immune function; immunogenicity; programs; research clinical testing; research study; sample collection; screening; transfusion medicine; vaccine candidate; vaccine development; volunteer

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).

该疫苗研究中心 (VRC) 临床试验计划 (CTP) 项目的目的是筛选志愿者，了解涉及研究药物管理的方案，并收集人体样本，例如血液、粘膜分泌物、皮肤拭子、皮肤活检或体液，并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的研究测定 免疫原性结果。 实验室研究人员在开发针对艾滋病毒和其他新出现的传染病的疫苗和单克隆抗体的工作中使用这些样本和数据，以研究与传染病相关的免疫相关性，以及与免疫分析的开发和/或验证相关的实验室工作。 为了进行研究，有时需要获得比通过简单放血安全获得的数量更多的血浆或单核细胞。 这些成分可以通过美国国立卫生研究院临床中心输血医学部 (DTM) 进行的单采术安全地获得。