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

> **NIH NIH U19** · UNIV OF MARYLAND, COLLEGE PARK · 2021 · $457,430

## Abstract

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.

## Key facts

- **NIH application ID:** 10260849
- **Project number:** 1U19AI162130-01
- **Recipient organization:** UNIV OF MARYLAND, COLLEGE PARK
- **Principal Investigator:** Donald Kirby Milton
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $457,430
- **Award type:** 1
- **Project period:** 2021-09-01 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10260849

## Citation

> US National Institutes of Health, RePORTER application 10260849, Evaluating Modes of Influenza Transmission using a Randomized Controlled Trial (EMIT-2-RCT) (1U19AI162130-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10260849. Licensed CC0.

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