Clinical and Biostatistics Core

项目摘要/摘要-临床和生物统计学核心 临床和生物统计学核心(CBC)是流感评估模式的核心组成部分 传输(发射-2)程序。这个核心的总体目标是进行一系列随机临床试验 综合评价病毒、宿主、身体和环境因素的流感传播研究 促进有效的人与人之间的流感传播。在这些研究中，健康的参与者有 没有或很低水平的血凝抑制抗体将用于本年度的疫苗株 与自然感染流感病毒并由Research招募的参与者接触长达四天 项目1(RP1)。该系列中的每项研究都将采用环境干预和个人保护措施。 研究项目2(RP2)设计的干预措施。核心将为临床数据的收集提供平台 和环境样本，分别由两个项目和先进生物气溶胶技术核心 (ABTC)。该项目的临床研究机构Pharmaron Baltimore有很长的合作历史 与马里兰大学疫苗开发中心合作，是NIAID公民项目的一个网站。 这一核心的目标将通过以下具体目标实现：(1)提供监管和安全 流感传播随机对照试验的基础设施；(2)健康成年志愿者的筛查 (接受者)，愿意在住院期间暂时住在隔离病房约2周 流感季节，以及急性流感感染的指示病例(捐赠者)；以及(3)暴露未感染者符合条件 志愿者向流感感染指标性病例患者。将设立一个独立的数据和安全监测委员会 集合起来对传输研究的进行进行安全监督。终极监督 CBC的活动将由核心负责人(陈博士)和联合调查员(奥尔蒂斯博士)负责，并将 包括与这架U19的项目和核心密切协调。

Project Summary/Abstract – Clinical and Biostatistics Core The Clinical and Biostatistics Core (CBC) is a central component of the Evaluating Modes of Influenza Transmission (EMIT-2) program. The overall objective of this core is to perform a series of randomized clinical studies of influenza transmission to comprehensively evaluate viral, host, physical, and environmental factors that facilitate efficient human-to-human influenza transmission. In these studies, healthy participants who have no or very low levels of hemagglutination inhibiting antibodies to the current year’s vaccine strains will spend up to four days in contact with participants naturally infected with influenza virus and recruited by Research Project 1 (RP1). Each study in the series will employ an environmental intervention and a personal protection intervention designed by Research Project 2 (RP2). The core will provide the platform for collection of clinical and environmental samples by each of the two projects and the Advanced Bioaerosol Technology Core (ABTC). The clinical research facility for this project, Pharmaron Baltimore, has a long history of collaboration with the University of Maryland Center for Vaccine Development and is a site for the NIAID CIVIC program. The goals of this core will be achieved through the following specific aims: (1) Provide regulatory and safety infrastructure for a randomized controlled trial of influenza transmission; (2) Screen for healthy adult volunteers (Recipients), willing to temporarily reside on an inpatient containment unit approximately 2 weeks during the influenza season, and index cases with acute influenza infection (Donors); and (3) Expose un-infected eligible volunteers to influenza-infected index case patients. An independent Data and Safety Monitoring Board will be assembled to provide safety oversight over the conduct of the transmission studies. Ultimate oversight of the CBC’s activity will be the responsibility of the Core Leader (Dr. Chen) and Co-Investigator (Dr. Ortiz) and will include close coordination with the Projects and Cores of this U19.