Emory University
The purpose of this study is to determine whether influenza A or B can be transmitted from adults with naturally acquired community influenza infection to healthy adult recipients under controlled inpatient exposure conditions, and to identify donor, recipient, viral, immunologic, behavioral, and environmental factors associated with transmission. This study differs from a traditional influenza CHIM because no challenge stock will be administered. Instead, naturally infected community donors will serve as the source of exposure. This approach is intended to better reflect naturally circulating influenza viruses and naturally infected donors while preserving the safety advantages of inpatient monitoring, defined exposure windows, controlled environmental measurements, and standardized sampling.
Influenza remains a major cause of respiratory illness, hospitalization, and death worldwide. Seasonal influenza vaccines and antivirals are available, though vaccine effectiveness varies by season and by match between vaccine and circulating strains, and antivirals are most effective when administered early. Improved methods are needed to understand how influenza transmits between humans and to identify donor, recipient, viral, immune, and environmental factors that influence transmission. Controlled human infection models (CHIM) for influenza have provided important information about influe…
Recipient Inclusion Criteria: 1. Provide written informed consent before initiation of any study procedures. 2. Are able to understand and comply with all planned study procedures, including inpatient quarantine, donor-exposure sessions, infection-control procedures, symptom reporting, specimen collection, and follow-up. 3. Healthy adults aged ≥18 and ≤49 years at the time of first donor exposure. 4. Participants who can become pregnant must be practicing abstinence or using an acceptable method of contraception for at least 30 days before first donor exposure and through Day 91. A participan…
Donor participants will have screening/testing with a same-day donor visit. The donor visit involves a donor exposure session and/or research sampling prior to discharge from donor visit.If eligible, repeat donor visits are possible. Study staff will monitor exposure sessions and will stop a session for participant safety or donor clinical deterioration.
Recipient are admitted to the Emory University Hospital challenge unit in cohorts of 2-10 recipients. Each cohort may be exposed to one or more naturally infected donors over up to 7 donor-exposure days. Exposure sessions may last up to 4 continuous hours and no more than 8 total exposure hours per day. During exposure sessions, donors and recipients may participate in structured social activities such as conversation, reading aloud, singing, games, light group activities, and shared-object activities. Environmental conditions may be collected to help interpret transmission outcomes. Recipients testing negative may be discharged 4 days after last exposure, while those testing positive may be discharged 7 days after the last exposure day before conversion, with discharge delayed if not clinically stable. Outpatient follow-up occurs for up to 91 days with an optional visit at Day 365 for research sampling.
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