NCT05666245

DMID 21-0041; Influenza CVD 59000

Evaluating Modes of Influenza Transmission Through the Conduct of Controlled Human Influenza Virus Infection Transmission Trials (CHIVITTs)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified.

Conditions

• Influenza

Interventions

Type	Name	Description
BEHAVIORAL	Personal Protective Equipment (PPE) - Under High Air Hygiene	Intervention Recipients (IRs) will be required to wear a lightweight plastic face shield, comply with hand hygiene (i.e., using a hand sanitization product every 15 minutes, plus periodic hand washing with soap and water), and avoid face touching during each planned exposure event. The face shield may only be removed after leaving the exposure room to go to the bathroom, for other short comfort breaks, and at mealtimes. In these instances, hand hygiene will be used after removing or replacing the face shield; and Donors will not be present. Hand washing with soap and water will be required before meals. IR will be separated from Donors by more than 6 feet during meals. The exposure room will be supervised by a trained member of the study staff who will monitor to ensure that Intervention Recipients wear the face shield continuously, are separated from Donors at meals, and do not touch their faces. High air hygiene is achieved by filtration and/or use of germicidal UV-C.
BEHAVIORAL	No Intervention - Under High Air Hygiene	No intervention High air hygiene is achieved by filtration and/or use of germicidal UV-C.
BEHAVIORAL	Personal Protective Equipment (PPE) - Under Low Air Hygiene	Intervention Recipients (IRs) will be required to wear a lightweight plastic face shield, comply with hand hygiene (i.e., using a hand sanitization product every 15 minutes, plus periodic hand washing with soap and water), and avoid face touching during each planned exposure event. The face shield may only be removed after leaving the exposure room to go to the bathroom, for other short comfort breaks, and at mealtimes. In these instances, hand hygiene will be used after removing or replacing the face shield; and Donors will not be present. Hand washing with soap and water will be required before meals. IR will be separated from Donors by more than 6 feet during meals. The exposure room will be supervised by a trained member of the study staff who will monitor to ensure that Intervention Recipients wear the face shield continuously, are separated from Donors at meals, and do not touch their faces. Low air hygiene is achieved with minimal ventilation.
BEHAVIORAL	No Intervention - Under Low Air Hygiene	No intervention Low air hygiene is achieved with minimal ventilation.

Timeline

• Start date: 2023-02-20
• Primary completion: 2024-04-17
• Completion: 2024-04-17
• First posted: 2022-12-27
• Last updated: 2025-08-26
• Results posted: 2025-08-26

Locations

2 sites across 1 country: United States