Influenza Human Challenge Model
ConditionInfluenza
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-49
SponsorEmory University
About this trial
This study examines how the immune system responds to the flu virus (H3N2) during and after infection and how the flu virus is transmitted in the environment. The study will used a flu virus called the H3N2 influenza challenge virus which was produced specifically for use in clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy subjects. Mild to moderate symptoms are expected based on previous studies with this strain of influenza.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provide written informed consent prior to initiation of any study procedures.
Are able to understand and comply with all planned study procedures.
Healthy males and non-pregnant, non-breast-feeding females aged ≥18 and ≤49 years of age inclusive at enrollment.
Women of childbearing potential must be practicing abstinence or using an acceptable method of birth control for at least 30 days prior to enrollment through the duration of the trial. Male subjects must agree not to father a child for the duration of the trial.
Disqualifiers
Children under 5 years of age
Children and/or teenagers who are receiving long-term aspirin therapy
Women who are pregnant or who are trying to become pregnant
Persons older than 65 years of age
Trial design
Design model
Single group
Treatments tested in this trial
Influenza Virus Type A H3N2 Challenge
Biological/VaccineThe intervention product is a live challenge virus that is manufactured in the USA under Good Manufacturing Practice (GMP). The challenge will be administered intranasally using a sprayer device, by natural exposure to infected participants, by inhalation from an aerosol generator or nebulizer, or by inhalation within a tent. Participants will be admitted to the hospital and quarantined for 8 to 12 days for monitoring, and will receive care and supportive treatment as necessary. Participants will be followed for a total of 12 weeks.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Influenza Challenge Model with Influenza A H3N2 StrainExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Mild to Moderate Influenza Disease
The number of participants experiencing mild to moderate influenza disease (MMID) from challenge to discharge from quarantine.
Time frame
Up to Day 82
Number of Serious Adverse Events
The number of serious adverse events during the duration of the study will be evaluated.
Time frame
Up to Week 123
Number of Participants with Severe Influenza Disease
The number of participants experiencing severe influenza disease (MMID) from challenge to discharge from quarantine.
Time frame
Up to Week 12Secondary outcomes
1
Change in Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI)
The GMT of HAI to the challenge H3N2 strain will be evaluated.
Time frame
Baseline, Day 282
Change in Geometric Mean Fold Rise (GMFR) of HAI
The GMFR of HAI to the challenge H3N2 strain will be evaluated.
Time frame
Baseline, Day 283
Change in Number of Participants with 4-fold Rise in HAI
The number of participants with a 4-fold rise in HAI will be evaluated.
Time frame
Baseline, Day 28Sponsors and contacts
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Source ClinicalTrials.gov