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: 10471987
• 负责人: Donald Kirby Milton
• 金额: $ 59.47万
• 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/10471987
• 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 – 使用随机模型评估流感传播模式 对照试验 “使用随机对照试验评估流感传播模式 (EMIT-2-RCT)” 研究项目解决了一个关键的知识差距，即缺乏有关机制的明确证据 传播，特别是与病毒相比，病毒气溶胶（空气传播或气溶胶传播）的重要性 接触-污染物和喷雾（也称为飞沫）传播。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际流感 传播并提供对血凝缺失或低血凝情况下保护相关性的见解 使用新颖的研究设计抑制（HI）抗体。在此过程中，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流感的主要原因 传播，通风和减少气溶胶暴露与减少两种发作有关 率和疾病严重程度。我们在量化传染性呼出气溶胶方面具有独特的优势 Gesundheit-II 之前是在 PI 实验室中开发的，并与 高度多学科的团队。我们将综合评估通过直接接触、污染物、 通过进行新型随机试验，将喷雾滴和气溶胶作为促进传播的因素 七组对照试验，每组有 4 名自然感染的捐赠者和 18 名接受者。临床和 生物统计学核心将提供招募和筛选参与者以及临床监督的基础设施 检疫设施。在每组中，我们将随机分配一半接受者进行手部卫生-面部护理 盾牌干预。第一年的第一组将处于低通风环境中。在第 2-4 年，我们将 每年进行两次暴露组，一组在低通风环境中，一组在高通风环境中 环境上层有杀菌紫外线空气卫生。具体来说，我们将：（1）识别主导模式 使用自然感染的捐赠者进行随机对照的社区获得性感染的传播 尝试空气卫生-通风和手部卫生-面罩干预措施； (2) 确定影响 气溶胶暴露对疾病严重程度的影响； (3) 研究血清学和粘膜抗体水平的影响 在没有或非常严重的情况下流感传播、易感性和对感染的免疫反应 血凝抑制抗体水平低。这项独特的随机对照试验将提供 对气溶胶在传播中的作用进行明确评估，并提供建立有效的关键数据 非药物干预措施并评估疫苗的功效和对传播的治疗影响。