Influenza Human Challenge Model

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05332899
Phase
PHASE1
Status
Recruiting
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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • Influenza Virus Type A H3N2 Challenge — BIOLOGICAL
    The 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.

Study Details

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.

Key Dates

Start date
May 24, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Influenza Challenge Model with Influenza A H3N2 Strain
    Participants exposed to a previously validated influenza challenge model with influenza A H3N2 strain (A/Perth/16/2009 H3N2).

Primary Outcome Measure

Number of Participants with Mild to Moderate Influenza Disease [ Time Frame: Up to Day 8 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Nadine Rouphael, MD
[email protected]
(404) 712-1435
Nadine Rouphael, MD (PRINCIPAL_INVESTIGATOR)
Hope ClinicAtlantaGeorgia30030
Nadine Rouphael, MD
[email protected]
(404) 712-1435
Nadine Rouphael, MD (PRINCIPAL_INVESTIGATOR)

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Emory University Hospital· Atlanta, GAHope Clinic· Atlanta, GA

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