Sample Collection and General Screening Protocols

样品采集和一般筛选方案

• 批准号: 10928009
• 负责人: Lesia Dropulic
• 金额: $ 192.34万
• 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/10928009
• 关键词: Axillary lymph node group; B-Lymphocytes; Binding Sites; Biological Assay; Biological Factors; Biopsy; Blood; Blood Component Removal; Body Fluids; Cells; Clinical Trials; Communicable Diseases; Correlation Studies; Data; Development; Eligibility Determination; Emerging Communicable Diseases; Enrollment; Evolution; Fine needle aspiration biopsy; Goals; HIV; HIV envelope protein; Human; Image Analysis; Immune; Immune response; Immunity; Immunology procedure; Influenza vaccination; Laboratories; Laboratory Research; Licensing; Messenger RNA; Methods; Monoclonal Antibodies; Mononuclear; Mucous Membrane; Nipah Virus; Pathogenesis; Plasma; Procedures; Protocols documentation; Research; Research Personnel; Sampling; Severity of illness; Skin; Specimen; Swab; Tissues; United States National Institutes of Health; Vaccinated; Vaccination; Vaccine Clinical Trial; Vaccine Research; Vaccines; Validation; Venous blood sampling; Virus Diseases; Work; clinical center; experience; healthy volunteer; immune function; immunogenicity; influenza virus vaccine; mosaic; nanoparticle; next generation; novel; programs; radiological imaging; recruit; research clinical testing; research study; response; sample collection; screening; screening program; transfusion medicine; vaccination protocol; vaccine candidate; vaccine development; vaccine-induced antibodies; 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 other 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. 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 blood components can be safely obtained using apheresis procedures, which are performed in the NIH Clinical Center Department of Transfusion Medicine. During FY23, healthy volunteers have been enrolled in the VRC/CTP screening protocol (VRC 500) to assess healthy volunteers for eligibility in the following trials: a next-generation HIV monoclonal antibody targeting the HIV envelope CD4 binding site; a novel mRNA Nipah virus vaccine; and a novel hexavalent mosaic nanoparticle influenza vaccine. In addition, a new effort to collect samples by fine-needle aspiration of an axillary lymph node after influenza vaccination was implemented under the specimen collection protocol VRC 900 with the goal of understanding evolution of the B cell response after vaccination.

该疫苗研究中心（VRC）临床试验计划（CTP）项目的目的是筛查志愿者的协议，涉及涉及研究剂的管理并收集人类标本，并收集人类标本，例如血液，粘膜分泌，皮肤拭子，皮肤活检或其他体液，以及在某些情况下进行临床研究，以进行放射学像评估，以进行放射学像的研究，并在某些情况下进行临床研究，并将试验的免疫原性结果。 实验室研究人员在其开发疫苗和单克隆抗体的开发中使用了这些样品和数据，以靶向HIV和其他新兴的感染性疾病，研究与传染病有关的免疫相关性，以及与免疫学分析的发展和/或验证有关的实验室工作。 为了进行研究，有时需要获得更多的血浆或单核细胞，而不是通过简单的静脉切开术安全获得。 这些血液成分可以使用分离术程序安全地获得，该手术程序是在NIH临床输血医学部门进行的。 在23财年期间，在VRC/CTP筛查方案（VRC 500）中，健康志愿者已入学，以评估健康的志愿者在以下试验中的资格：下一代HIV HIV单克隆抗体，靶向HIV HIV CYNVELOPE CD4结合位点；一种新型的mRNA NIPAH病毒疫苗；以及一种新型的六价镶嵌纳米颗粒流感疫苗。此外，在样本收集方案VRC 900下实施了腋窝淋巴结的细针淋巴结的新努力，目的是了解疫苗接种后B细胞反应的演变。

项目成果

Multiplexed FluoroSpot for the Analysis of Dengue Virus- and Zika Virus-Specific and Cross-Reactive Memory B Cells.

• DOI: 10.4049/jimmunol.1800892
• 发表时间: 2018-12-15
• 期刊: Journal of immunology (Baltimore, Md. : 1950)
• 作者: Adam A;Woda M;Kounlavouth S;Rothman AL;Jarman RG;Cox JH;Ledgerwood JE;Gromowski GD;Currier JR;Friberg H;Mathew A
• 通讯作者: Mathew A