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

采用随机抽样的流感传播项目总结/摘要评价模式 对照试验 “使用随机对照试验评估流感传播的模式(EMIT-2-RCT)” 研究项目解决了一个关键的知识缺口，即缺乏关于心力衰竭机制的确凿证据 传播，特别是病毒气雾剂(气传或气雾剂传播)与 接触式和喷雾式(也称为液滴)传输。这个项目的总体目标是 评估病毒气雾剂脱落和通风如何相互作用促进人传人流感 并提供对无血凝或低血凝环境中保护相关因素的洞察 使用一种新的研究设计抑制(HI)抗体。在这样做的过程中，我们直接解决了NIAID的目标1.1 战略规划。我们的中心假设是传染性气溶胶是导致流感的主要因素。 传播、通风和减少气雾剂暴露与减少这两种攻击有关 发病率和疾病严重程度。我们在量化传染性呼出气溶胶方面具有独特的优势。 之前在PI的实验室开发的Gesundheit-II，并与 高度多学科的团队。我们将全面评估通过直接接触、混合接触、 喷雾剂和气雾剂作为促进传播的因素进行了一种新的随机 对照试验共7组，每组4名自然感染供者和18名受者。临床和医学研究 生物统计核心将提供招募和筛选参与者以及临床监督的基础设施 隔离设施的一部分。在每组中，我们将随机选择一半的受试者进行手部卫生-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2-4年内，我们将 每年进行两个暴露组，一个在低通风环境中，另一个在高通风环境中 室内环境采用紫外线杀菌，空气卫生。具体来说，我们将：(1)确定主导模式 自然感染献血者与社区获得性感染的传播在随机对照中的研究 空气卫生试验.通风和手卫生.面罩干预；(2)测定 气雾剂暴露对疾病严重程度的影响；以及(3)调查血清学和粘膜抗体水平的影响 无、非常环境下流感传播、易感性和免疫应答的研究 低水平的血凝抑制抗体。这项独特的随机对照试验将提供一种 明确评估气溶胶在传播中的作用，并提供关键数据，以便建立有效的 非药物干预，并评估疫苗的效力和治疗对传播的影响。

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.