Sample Collection and General Screening Protocols

样品采集和一般筛选方案

• 批准号: 9562819
• 负责人: Julie E. Ledgerwood
• 金额: $ 180.15万
• 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/9562819
• 关键词: Biological Assay; Biopsy; Blood; Blood Component Removal; Body Fluids; Cells; Clinical; 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; Medicine; Methods; Monoclonal Antibodies; Mononuclear; Pathogenesis; Plasma; Procedures; Protocols documentation; Research; Research Personnel; Sampling; Severity of illness; Skin; Specimen; Swab; Tissues; Transfusion; United States National Institutes of Health; Vaccinated; Vaccine Clinical Trial; Vaccines; Validation; Venous blood sampling; Virus Diseases; Work; experience; healthy volunteer; immune function; immunogenicity; research clinical testing; research study; sample collection; screening; vaccine candidate; vaccine development; volunteer

The purpose of this 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).

本项目的目的是筛选志愿者，以了解涉及研究药物给药的方案，并收集人体标本，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价，以支持实验室研究，并验证临床试验免疫原性结果评价中使用的研究测定。 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兴传染病的疫苗和单克隆抗体，研究与传染病相关的免疫相关性，以及与开发和/或验证免疫测定相关的实验室工作。 为了进行研究，有时需要获得比通过简单静脉切开术安全获得的更大量的血浆或单核细胞。 这些成分可以使用在NIH临床中心输血医学部（DTM）进行的单采程序安全地获得。