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

核心 B：对疫苗接种的先天和适应性反应的系统生物学分析

• 批准号: 10345983
• 负责人: Mark Joseph Mulligan
• 金额: $ 46.64万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10345983
• 关键词: Adult; Biological Assay; Blood; Case Report Form; Chickenpox Vaccine; Child; Clinic; Clinical; Clinical Protocols; Clinical Research; Colorado; Communities; Consent Forms; Data; Education and Outreach; Elderly; End Point Assay; Enrollment; Ensure; Good Clinical Practice; Herpesvirus Type 3; Human; Immune response; Immunocompromised Host; Monitor; Natural Immunity; Pneumococcal vaccine; Population; Preparation; Progress Reports; Publications; Records; Reporting; Research; Research Design; Research Project Grants; Research Support; Serology; Shipping; Source; Specimen; Streptococcus pneumoniae; System; Universities; Vaccination; Vaccines; Zoster Vaccine; adaptive immunity; biological systems; clinical database; design; participant safety; programs; recruit; response; sample collection; screening; success; transplant centers; vaccine trial

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.

抽象的 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类 来自不同研究的临床标本和数据，以更好地了解适应性和 对肺炎链球菌和水痘带状疱疹病毒疫苗接种的先天免疫。 临床核心的具体目的是： 具体目的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。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；获得所需的 监管批准；设计病例报告表格和临床数据库；外展 以及与将要招募的社区的教育；招聘，筛选， 和入学；根据良好的临床实践（GCP）进行临床研究行为 标准；建立一个记录系统，包括来源数据和必需品 文件；主题安全监控；临床标本收集，处理，跟踪， 存储和运输；准备进度报告，最终报告，演示和 出版物。 特定目的2）用水痘疫苗，带状疱疹疫苗进行临床研究， 和不同人群中的肺炎球菌疫苗（儿童，成人，老年人和 免疫功能低下）将提供必要的临床标本和数据 实现相关研究项目的科学目标。 特定目的3）执行终点免疫反应的测定 提供读取的水痘带状疱疹病毒（VZV）血清学和血液计数测定法。