Exposure Study for Flu Transmission
(EMIT-2b-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study how the flu spreads from person to person. Participants, called Recipients, will interact with individuals who have the flu, known as Donors, in a controlled setting to observe transmission. The trial requires a commitment to semi-quarantine at home and daily health checks. People who are generally healthy and can follow the trial's safety precautions, such as wearing masks and avoiding social gatherings, might be a good fit. Participants may receive some care if they catch the flu, but this does not replace regular medical care. As an unphased trial, this study offers a unique opportunity to contribute to important research on flu transmission.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking medications that affect your immune system, like high-dose corticosteroids, you may not be eligible to participate.
What prior data suggests that this exposure study is safe for participants?
Research shows that proximity to people with the flu, especially if they are coughing or sneezing, can lead to infection. The flu, short for influenza, is a virus that spreads easily from person to person. Most people who contract the flu experience symptoms like fever, headache, and fatigue, which usually appear 1 to 4 days after exposure.
While the flu can cause significant discomfort, it is usually not life-threatening for healthy individuals. However, severe cases can occur, so monitoring symptoms closely is important. If symptoms become serious, medical care may be necessary. In this study, participants will be exposed to the flu in a controlled environment, with safety measures and medical support in place. Regular health check-ups will be provided, and antiviral medication will be available if needed.
Joining this study might increase the risk of contracting the flu, but medical assessments and potential treatments will be provided to help manage any infections.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a unique way to understand how the flu virus spreads in real-world conditions. Unlike traditional studies that often focus on vaccines or antiviral medications, this trial directly observes flu transmission by having participants interact in controlled settings. By simulating everyday activities like playing games and shaking hands, the trial aims to uncover how flu spreads and what behaviors might increase or decrease risk. This could lead to better prevention strategies and help control outbreaks more effectively.
Who Is on the Research Team?
Donald K Milton, MD, DrPH
Principal Investigator
University of Maryland School of Public Health
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-49 who understand the study, can self-quarantine in a single occupancy bedroom, and avoid contact with others outside of controlled exposure events. They must not have had any significant health changes recently and agree to attend daily assessments, clinic visits, and evening sessions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Home Semi-Quarantine
Participants undergo a home semi-quarantine for about 14 days, wearing an N95 mask in class and taking other precautions
Controlled Environment Exposure
Participants spend weekday evenings in a controlled environment, exposed to people infected with influenza
Follow-up
Participants are monitored for safety and effectiveness after exposure, including a follow-up clinic visit and phone call
What Are the Treatments Tested in This Trial?
Interventions
- Exposure to Donors with naturally acquired influenza virus infection
Trial Overview
The study investigates person-to-person transmission of influenza by exposing healthy 'Recipients' to 'Donors' with naturally acquired flu. It includes home semi-quarantine, wearing N95 masks in class, controlled environment interactions, blood draws at specific intervals, and follow-ups.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Recipients are exposed to Donors in a controlled environment while performing prescribed activities, including playing cards and other games, and periodically shaking hands with Donors and rubbing their own nose and eyes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, College Park
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Citations
Influenza | Yellow Book
The incubation period is usually 1–4 days after exposure. Most adults ill with influenza shed the virus in the upper respiratory tract and are ...
Influenza virus type A: Infectious substances pathogen ...
The strains were also killed after 30 minutes of UV exposure, or at a pH of less than 2 for 0.5 hour or pH 3 for 24 hours. Survival outside host.
3.
vdh.virginia.gov
vdh.virginia.gov/content/uploads/sites/3/2025/02/VDH-Guidance-on-Monitoring-Healthcare-Providers-Exposed-to-Novel-Influenza-A-Viruses.pdfVDH Recommendations for Healthcare Providers Exposed ...
The HCP should self-isolate at home, not report to work, wear a facemask and implement strict respiratory hygiene around others, and seek prompt medical ...
4.
ehs.cornell.edu
ehs.cornell.edu/research-safety/biosafety-biosecurity/biological-safety-manuals-and-other-documents/bars-other/influenza-a-virusInfluenza A Virus Biological Agent Reference Sheet (BARS)
Health Hazards Signs and symptoms of infection may include: Flu-like symptoms (i.e., fever, headache, dehydration, weight loss, lethargy) ...
Influenza (seasonal)
There are around a billion cases of seasonal influenza annually, including 3–5 million cases of severe illness.
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