Clinical Research Core

这个人类免疫学转化研究合作中心的目标是， 生物防御是利用对疫苗诱导的和自然获得的甲型流感免疫力的分析， 定义儿童适应性和先天免疫机制以及抗病毒保护的模型， 成年人了临床研究中心将负责协调方案设计， 实施，提供生物统计支持，获得人类受试者批准，以及创建和 管理集中式数据库以记录临床和实验室数据。临床研究核心 将包括一个实验室，接收血液和呼吸道标本，进行初步样本处理， 并将相关样本分发给参与实验室，进行血清学检测， 甲型流感感染的快速诊断测试，并存档和储存选定的标本，以备将来使用 分析。集中这些职能对于确保最有效地利用小型 大量儿科血液样本。随着工作的进行，核心数据库将有助于比较 分析从个别研究项目获得的结果。具体目标是目标1： 设计临床研究和数据分析计划，为临床研究提供必要的IRB提交资料 研究，招募成人和儿童并将其纳入临床方案，确保受试者的权利 我们将继续努力，确保收集完整的数据集。目标2”提供初始 样本处理和血液或唾液样本分发给主要研究者，执行 确定基线甲型流感免疫状态和测量抗体的标准血清学测定 接种疫苗或自然感染。核心还将进行直接甲型流感快速 诊断测试招募儿童进行自然甲型流感感染研究。呼吸道样本来自 在流感期间，核心人员将每周收集疫苗研究中的儿童子集 赛季目标3”为中心提供集中的数据管理和生物统计支持。的 因此，临床研究支持中心将管理样本采集所依据的临床方案。 收集用于所有研究项目和研究资源技术开发项目。

The objective of this Cooperative Center for Translational Research on Human Immunology and Biodefense is to use analysis of vaccine-induced and naturally acquired immunity to influenza A as a model for defining adaptive and innate immune mechanisms and antiviral protection in children and adults. The Clinical Research Core will be responsible for coordinating protocol design and implementation, providing biostatistical support, obtaining human subjects approvals, and creating and managing the centralized database to record clinical and laboratory data. The Clinical Research Core will include a laboratory to receive blood and respiratory specimens, carry out initial sample processing and to distribute relevant specimens to the participating laboratories, perform serology assays and rapid diagnostic tests for influenza A infection, and archive and store selected specimens for future analyses. Centralizing these functions is particularly important to assure the most efficient use of small volume pediatric blood samples. As the work proceeds, the Core database will facilitate comparative analyses of results obtained from the individual Research Projects. The Specific Aims are Aim 1: To design the clinical study and data analysis plan, make the necessary IRB submissions for clinical studies, recruit and enroll adults and children into clinical protocols, assure that subject rights are respected, and provide follow-up to assure collection of complete sets of data. Aim 2" To provide initial sample processing and distribution of blood or saliva samples to the Principal Investigators, perform standard serologic assays to determine baseline influenza A immune status and measure antibody responses to vaccination or natural infection. The Core will also perform direct influenza A rapid diagnostic tests to recruit children for study of natural influenza A infection. Respiratory samples from a subset of children in the vaccine study will be collected weekly by Core personnel during the flu season. Aim 3" To provide centralized data management and biostatistical support for the Center. The Clinical Research Support Core will thus administer the clinical protocols under which samples are collected for use in all Research Projects and Research Resource Technical Development Projects.