Evaluating Modes of Influenza Transmission using a Randomized Controlled Trial (EMIT-2-RCT)

使用随机对照试验 (EMIT-2-RCT) 评估流感传播模式

• 批准号: 10260849
• 负责人: Donald Kirby Milton
• 金额: $ 45.74万
• 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/10260849
• 关键词: Address; Adult; Aerosols; Air; Antibodies; Biomedical Engineering; Biostatistics Core; Carbon Dioxide; Clinical; Collaborations; Community-Acquired Infections; Controlled Environment; Data; Disease; Drops; Ensure; Environment; Exhalation; Exposure to; Face; Fever; Frequencies; Germicide; Goals; Hand; Hemagglutination; Human; Hygiene; Immune response; Infection; Influenza; Influenza A Virus, H3N2 Subtype; Infrastructure; Intervention; Knowledge; Maryland; Measurable; Measurement; Measures; Methods; Monitor; Mucous Membrane; National Institute of Allergy and Infectious Disease; Natural History; Neutralization Tests; Participant; Pathogenesis; Positioning Attribute; Predisposition; Quarantine; Randomized; Randomized Controlled Trials; Research; Research Design; Research Project Grants; Role; Route; Sanitation; Serology; Severity of illness; Strategic Planning; System; Technology; Testing; Therapeutic; Universities; Viral; Virus; air sampling; base; design; experience; experimental study; flu transmission; improved; influenza infection; inhibiting antibody; innovative technologies; insight; instrument; instrumentation; multidisciplinary; novel; prevent; recruit; transmission process; universal influenza vaccine; universal vaccine; vaccine efficacy; ventilation

Project Summary/Abstract – Evaluating Modes of Influenza Transmission using a Randomized Controlled Trial The “Evaluating Modes of Influenza Transmission using a Randomized Controlled Trial (EMIT-2-RCT)” research project addresses a key knowledge gap, the lack of definitive evidence regarding the mechanisms of transmission, in particular the importance of viral aerosols (airborne or aerosol transmission) as compared with contact - fomite and sprayborne (also called droplet) transmission. The overall objective of this project is to evaluate how viral aerosol shedding and ventilation interact to facilitate human-to-human influenza transmission and provide insights into correlates of protection in the setting of absent or low hemagglutination inhibiting (HI) antibodies using a novel study design. In doing so, we directly address objective 1.1 of the NIAID strategic plan. Our central hypothesis is that infectious aerosols are a major contributor to influenza transmission and that ventilation and reduced aerosol exposure are associated with reduction of both attack rates and disease severity. We are uniquely positioned to quantify infectious exhaled breath aerosols with the Gesundheit-II previously developed in the PI’s lab and to extend these measurements in collaboration with a highly multidisciplinary team. We will comprehensively evaluate exposure via direct contact, fomites, sprayborne drops, and aerosols as factors facilitating transmission by conducting a novel randomized controlled trial of seven groups with 4 naturally infected Donors and 18 Recipients per group. The Clinical and Biostatistics Core will provide the infrastructure to recruit and screen the participants and the clinical oversight of the quarantine facility. Within each group, we will randomize half of the Recipients to a hand hygiene–face shield intervention. The first group in year-1 will be in a low ventilation environment. In years 2-4 we will conduct two exposure groups per year, one in a low ventilation environment and one in a high ventilation environment with upper-room germicidal UV air sanitation. Specifically, we will: (1) Identify the dominant mode of transmission using naturally infected Donors with community acquired infection in a randomized controlled trial of air sanitation-ventilation and hand hygiene–face shield interventions; (2) Determine the impact of aerosol exposure on disease severity; and (3) Investigate the impact of serologic and mucosal antibody levels on influenza transmission, susceptibility and immunologic response to infection in the setting of absent or very low levels of hemagglutination inhibiting antibodies. This unique randomized controlled trial will provide a definitive assessment of the role of aerosols in transmission and provide critical data on which to build effective non-pharmaceutical interventions and assess efficacy of vaccine and therapeutic impacts on transmission.

项目摘要/摘要 - 使用随机分组评估流感传播模式 对照试验 “使用随机对照试验（EMIT-2-RCT）评估流感传播模式” 研究项目解决了一个关键知识差距，缺乏有关机制机制的明确证据 传播，特别是病毒气溶胶（机载或气溶胶传输）的重要性 接触 - Fomite和Sprayborne（也称为液滴）传输。该项目的总体目标是 评估病毒气溶胶脱落和通风如何相互作用以促进人类到人类的影响 在不存在或低血凝的情况下传播并提供有关保护相关的洞察力 使用新型研究设计抑制（HI）抗体。为此，我们直接解决了NIAID的目标1.1 战略计划。我们的中心假设是传染性气溶胶是影响力的主要贡献者 传输以及通风和降低的气溶胶暴露与两种攻击的减少有关 发生率和疾病的严重程度。我们的位置是量化感染性疲惫的呼吸气溶胶的位置 Gesundheit-II以前在Pi的实验室中开发，并与 高度多学科团队。我们将通过直接接触，Fomites，全面评估暴露 通过进行新颖的随机分组，喷雾寄生的滴剂和气溶胶作为促进传播的因素 每组有4个自然感染的捐助者和18名接受者的七个组的对照试验。临床和 生物统计学核心将为招募和筛选参与者和临床监督提供基础设施 隔离设施。在每个组中，我们将将一半的接受者随机为手卫生。 盾牌干预。 1年级的第一组将处于低通风环境中。在2 - 4年中，我们将 每年进行两个曝光组，一个在低通风环境中，一个在高通风中 带有上层室外紫外线空气卫生的环境。具体来说，我们将：（1）确定主要模式 使用自然感染的供体进行传播，并在随机控制中以社区获得感染 空气卫生通风和手卫生屏蔽干预措施的试验； （2）确定 气溶胶暴露于疾病严重程度； （3）研究血清学和粘膜抗体水平的影响 在不存在或非常非常的情况下，关于影响力的传播，敏感性和免疫反应 低水平的血凝抑制抗体。这个独特的随机对照试验将提供 对气溶胶在传输中的作用的确切评估，并提供有效的关键数据 疫苗的非药物干预措施和评估效率以及对传播的治疗影响。