A Human Influenza Transmission Study Using Naturally Infected Community Donors
ConditionInfluenza
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-49
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provide written informed consent before initiation of any study procedures.
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.
Healthy adults aged ≥18 and ≤49 years at the time of first donor exposure.
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 participant is considered not of childbearing potential if post-menopausal or surgically sterilized.
Disqualifiers
Children under 5 years of age.
Children or teenagers receiving long-term aspirin therapy.
Persons who are pregnant or trying to become pregnant.
Persons older than 65 years of age.
Trial design
Design model
Parallel
Treatments tested in this trial
Influenza Donor Visit
Other interventionDonor 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 interventionRecipient 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Influenza DonorsOther 1 intervention
Group B: Influenza RecipientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants Developing Influenza Infection
Secondary attack rate of laboratory-confirmed influenza infection among exposed recipients, defined as the proportion of healthy adult recipients who develop laboratory-confirmed influenza A or B infection after controlled exposure to one or more naturally infected adult community donors within the quarantine period.
Time frame
During the quarantine period (up to Day 14)2
Number of Recipients Experiencing A Serious Adverse Event
Safety of controlled exposure to naturally infected influenza donors in healthy adult recipients is assessed by the number and proportion of exposed recipients with serious adverse events.
Time frame
Up to Day 913
Number of Recipients with Severe Influenza Disease
Safety of controlled exposure to naturally infected influenza donors in healthy adult recipients is assessed by the number and proportion of exposed recipients with severe influenza disease. Severe influenza disease is defined as laboratory-confirmed influenza A or B infection plus persistent Grade 3 severity in respiratory rate, tachycardia, blood pressure, oxygen saturation, or temperature not attributed to another cause and sustained for two days; radiologically confirmed pneumonia; organ involvement such as encephalitis or myocarditis; or investigator determination that the clinical syndrome represents severe influenza disease.
Time frame
Up to Day 914
Number of Recipients Experiencing an Adverse Event
Safety of controlled exposure to naturally infected influenza donors in healthy adult recipients is assessed by the number and proportion of exposed recipients with adverse events.
Time frame
Up to Day 31Secondary outcomes
1
Frequency of Viral Shedding in Recipients
The frequency of influenza viral shedding in recipients following donor exposure within the quarantine period.
Time frame
During the quarantine period (up to Day 14)2
Timing of Viral Shedding in Recipients
The timing of influenza viral shedding in recipients following donor exposure within the quarantine period.
Time frame
During the quarantine period (up to Day 14)3
Duration of Viral Shedding in Recipients
The duration of influenza viral shedding in recipients following donor exposure within the quarantine period.
Time frame
During the quarantine period (up to Day 14)4
Magnitude of Viral Shedding in Recipients
The magnitude of influenza viral shedding in recipients following donor exposure within the quarantine period.
Time frame
During the quarantine period (up to Day 14)Sponsors and contacts
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Emory University
Lead sponsor
National Philanthropic Trust (NPT)
Collaborator
Source ClinicalTrials.gov
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