Clinical and Biostatistics Core

临床和生物统计学核心

• 批准号: 10260847
• 负责人: Wilbur H. Chen
• 金额: $ 102.2万
• 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/10260847
• 关键词: Acclimatization; Acute; Address; Adult; Aerosols; Baltimore; Biostatistics Core; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Collection; Consent; Containment; Controlled Environment; 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; Procedures; Process; Protocols documentation; Quality Control; Randomized; Randomized Controlled Trials; Recording of previous events; Research; Research Personnel; Research Project Grants; Safety; Sampling; Screening procedure; Seasons; Series; Serology; Site; Specific qualifier value; Standardization; Symptoms; Technology; Time; Training; Training and Infrastructure; 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; 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 传输（EMIT-2）程序。该核心的总体目标是进行一系列随机临床试验， 流感传播研究，全面评估病毒、宿主、物理和环境因素 促进流感在人与人之间的有效传播。在这些研究中， 没有或非常低水平的血凝抑制抗体对本年度的疫苗株将花费 与自然感染流感病毒并被研究招募的参与者接触长达四天 项目1（RP 1）。该系列中的每项研究都将采用环境干预和个人保护 研究项目2（RP 2）。该核心将为收集临床 两个项目和先进生物气溶胶技术核心的每一个项目的环境样品 （ABTC）。该项目的临床研究机构，康龙化成巴尔的摩，有着悠久的合作历史 与马里兰州大学疫苗开发中心合作，是NIAID CIVIC项目的一个站点。 这一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）健康成人志愿者的筛选 （接受者），愿意在治疗期间暂时居住在住院隔离病房约2周 流感季节和急性流感感染的指示病例（供体）;和（3）暴露未感染的合格 志愿者到流感感染的指示病例患者。一个独立的数据和安全监测委员会将 对传输研究的进行进行安全监督。最终监督 CBC的活动将由核心负责人（陈博士）和合作研究者（Ortiz博士）负责，并将 包括与U19的项目和核心密切协调。