Core B: System Biological Analyses of Innate and Adpative Responses to Vaccination

摘要 临床核心支持U19研究的两个研究项目 程序。临床核心将为研究项目提供适当的人力资源 临床标本和不同研究的数据，以更好地了解适应性和 肺炎链球菌和水痘带状疱疹病毒疫苗接种的先天免疫。 临床核心的具体目标是： 具体目标1)提供临床研究专业知识和能力，以确保 U19科学议程的成功。将提供的支持活动包括： 研究设计；临床方案和知情同意书的准备；所需的获取 监管审批；设计病例报告表和临床数据库；外展 以及与将进行招聘的社区进行教育；招聘、筛选、 根据良好临床实践(GCP)进行临床研究 标准；建立记录系统，包括源数据和基本数据 文件；受试者安全监测；临床标本收集、处理、跟踪 储存和运输；编写进度报告、最终报告、演示文稿和 出版物。 具体目的2)进行水痘疫苗、带状疱疹疫苗、 和肺炎球菌疫苗在不同人群(儿童、成人、老年人和 免疫功能受损)，将提供必要的临床标本和数据 完成相关研究项目的科学目标。 具体目标3)对终点免疫反应进行分析，以 为水痘带状疱疹病毒(VZV)血清学和血细胞计数分析提供读数。

Abstract The Clinical Core serves to support the two research projects of the U19 research program. The Clinical Core will provide the research projects with appropriate human clinical specimens and data from different studies to better understand adaptive and innate immunity to vaccination for Streptococcus pneumoniae and varicella zoster virus. The specific aims of the Clinical Core are: Specific aim 1) To provide clinical study expertise and capacity to ensure the success of the U19 scientific agenda. The support activities to be provided include: study design; clinical protocol and informed consent form preparation; obtaining required regulatory approvals; designing case report forms and the clinical database; outreach and education with communities in which recruiting will occur; recruitment, screening, and enrollment; clinical study conduct according to Good Clinical Practice (GCP) standards; establish a system of records, including source data and essential documents; subject safety monitoring; clinical specimen collection, processing, tracking, storage, and shipping; preparation of progress reports, final report, presentations, and publications. Specific aim 2) To perform clinical studies with varicella vaccine, zoster vaccine, and pneumococcal vaccines in different populations (children, adults, elderly and immunocompromised) that will provide the clinical specimens and data necessary to accomplish the scientific aims of the related research projects. Specific aim 3) To perform assays for endpoint immune responses that will provide read out for varicella zoster virus (VZV) serology and blood count assays.