A Human Influenza Transmission Study Using Naturally Infected Community Donors

Conditions

• Influenza

Eligibility Criteria

Sex

ALL

Age

18 Years - 49 Years

Healthy Volunteers

Accepted

Interventions

• Influenza Donor Visit — OTHER
  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.
• Influenza Recipient Inpatient Exposures Sessions — OTHER
  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.

Study Details

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.

Key Dates

First listed

Sep 11, 2026

Start date

Dec 31, 2026

Status verified

Sep 2026

Primary completion

Mar 31, 2031

Completion

Mar 31, 2031

Study Design

Enrollment

150 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Other: Influenza Donors
  Adults with naturally acquired community influenza A or B infection are enrolled as donors.These donors are not experimentally infected by the study. Instead, donors are identified rapidly from the community, tested by rapid antigen and/or polymerase chain reaction (PCR), and brought to the controlled exposure unit for same-day donor visits.
• Experimental: Influenza Recipients
  Healthy adult recipients are admitted to the Emory University Hospital challenge unit and intentionally exposed to one or more naturally infected donors under controlled inpatient conditions over multiple exposure days.

Primary Outcome Measure

Proportion of Participants Developing Influenza Infection [ Time Frame: During the quarantine period (up to Day 14) ]

Central Contacts

• Nadine Rouphael, MD, MSc
  404-712-1435
  [email protected]

Locations (2)

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