Clinical and Biostatistics Core

临床和生物统计学核心

• 批准号: 10645159
• 负责人: Wilbur H. Chen
• 金额: $ 145.21万
• 依托单位: UNIV OF MARYLAND, COLLEGE PARK
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10645159
• 关键词: Acclimatization; Acute; Address; Admission activity; Adult; Aerosols; Baltimore; Biostatistics Core; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Collection; Consent; Containment; Controlled Environment; Eligibility Determination; Enrollment; Ensure; Environmental Risk Factor; Event; Exhalation; Exposure to; Goals; Good Clinical Practice; Health; Hemagglutination; Human; Human Resources; Human Subject Research; Human Volunteers; Immunosuppression; Individual; Infection; Influenza; Informed Consent; Infrastructure; Inpatients; Institutional Review Boards; Intervention; Laboratories; Maryland; Masks; Mediating; Medical; Methods; Molecular Diagnostic Testing; National Institute of Allergy and Infectious Disease; Outcome; Participant; Patients; Population Heterogeneity; Predisposition; Procedures; Process; Protocols documentation; Quality Control; Randomized; Randomized, Controlled Trials; Recording of previous events; Research; Research Personnel; Research Project Grants; Risk Reduction; Safety; Sampling; Screening procedure; Seasons; Series; Serology; Site; Specific qualifier value; Standardization; Symptoms; Technology; Time; Training; Universities; Vaccines; Viral; Woman; care seeking; clinical infrastructure; cohort; design; environmental intervention; experience; experimental study; flu transmission; high risk; indexing; infection risk; influenza infection; influenza virus strain; influenza virus vaccine; inhibiting antibody; innovative technologies; men; programs; public health intervention; recruit; research facility; respiratory virus; seasonal influenza; therapy design; transmission process; vaccine development; volunteer; ward

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.

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 Transmission (EMIT-2) 计划的总体目标是执行一系列随机临床。 研究流感传播，综合评估病毒、宿主、物理和环境因素 促进有效的人际流感传播 在这些研究中，健康参与者患有流感。 今年的疫苗株不会产生血凝抑制抗体或水平非常低 与研究招募的自然感染流感病毒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防护。 研究项目2（RP2）设计的干预措施核心将为收集临床数据提供平台。 两个项目和先进生物气溶胶技术核心的环境样本 (ABTC) 该项目的临床研究机构 Pharmaron Baltimore 有着悠久的合作历史。 与马里兰大学疫苗开发中心合作，是 NIAID CIVIC 项目的网站。 该核心的目标将通过以下具体目标来实现： (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； （接收者），愿意在隔离期间暂时居住在住院隔离病房大约 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) 暴露符合条件的未感染者； 一个独立的数据和安全监测委员会将向流感感染指标患者提供志愿者服务。 聚集起来对传输研究的进行进行安全监督。 CBC 的活动将由核心领导者（陈博士）和联合研究员（奥尔蒂斯博士）负责，并将 包括与 U19 的项目和核心的密切协调。