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 is a research study to investigate how influenza transmits from person-to-person. Participation as a healthy "Recipient" in this study involves:
* Home semi-quarantine lasting about 14 days during which the participants must wear an N95 in class and take other precautions
* Daily assessments and clinic visits for 14 days
* Spending every weekday evening for about 14 days from around 6 - 10 pm, including a provided dinner, in a controlled environment. There may be additional sessions and different required participation times on weekends
* Exposure to people infected with influenza in the controlled environment
* Three blood draws, at the start, at the end of 14 days, and about a month after the end.
* A follow-up clinic visits one month after the end of home semi-quarantine
* A two-month follow-up phone call. This study may increase the participant's risk of catching influenza.
If the participants get infected during the study, the investigators may:
* Provide the participants with a prescription for antiviral medication or
* Refer the participants for medical care
* Ask the participants to become a Donor and expose other Recipients.
The participants will be compensated for their time and active participation in the study; however, they may not personally benefit from the study. While the participants may receive supportive care for an infection resulting from the study, this is not meant to replace their regular medical care. If the participants become very ill and need referral for medical care, they or their medical insurance will be billed.
If the participants are someone who recently became infected with influenza either through their daily activities or by participating in this study as a Recipient, they are invited to participate in this research study as a Donor and interact with a group of health participants in a controlled environment. Participation in this study as a Donor involves exposing Recipients for at least one and up to five days including:
* Attend exposure events in a controlled environment
* Weekday evenings from around 6-10 pm
* Additional day and evening events on weekends
* Events include a provided dinner
* Daily assessments and clinic visits for 1 to 5 days
* Provide exhaled breath samples for 30 to 60 minutes
* Three blood draws, at the start and end of exposure events, and about a month after the end
* A follow-up clinic visit one month after their last exposure event
* A two-month follow-up phone call
If the participants experience severe symptoms related to their influenza infection, we may:
* Provide the participants with a prescription for antiviral medication or
* Refer the participants for medical care
The participants will be compensated for their time and active participation in the study; however, they may not personally benefit from the study. While the participants may receive supportive care for their influenza infection, this is not meant to replace their regular medical care. If the participants become very ill and need referral for medical care, they or their medical insurance will be billed.
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
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