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）是评估流感模式的核心组成部分 传输（EMIT-2）程序。该核心的总体目的是执行一系列随机临床 对影响力传播的研究，以全面评估病毒，宿主，身体和环境因素 这有助于有效的人类对人类影响力的传播。在这些研究中，拥有的健康参与者 对于当年的疫苗菌株，没有或非常低的血凝抑制抗体 最多四天与自然感染影响病毒并通过研究招募的参与者接触 项目1（RP1）。该系列中的每项研究都将雇用环境干预和个人保护 研究项目2（RP2）设计的干预措施。核心将为收集临床的平台提供平台 以及两个项目中的每个项目和先进的生物Aerosol Technology Core的环境样本 （ABTC）。该项目的临床研究机构Pharmoron Baltimore拥有悠久的合作历史 马里兰大学疫苗开发中心，是NIAID公民计划的地点。 该核心的目标将通过以下特定目的实现：（1）提供监管和安全性 影响力传播的随机对照试验的基础设施； （2）健康的成人志愿者的屏幕 （接收者），愿意在大约2周内暂时居住在住院容器上 影响力季节和急性影响力感染的指数病例（供体）； （3）暴露未感染的符合条件 志愿者影响了ZA感染的指数病例患者。独立的数据和安全监控委员会将是 组装以提供对传输研究的进行的安全监督。最终监督 CBC的活动将是核心负责人（Chen博士）和共同投资者（Ortiz博士）的责任，并将 包括与该U19的项目和核心的密切协调。