A/Texas Flu Challenge

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06753474
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 influenza A H3N2 strain — BIOLOGICAL
    Live Influenza Virus RG-A/Texas/71/2017 (H3N2). It is a cell-grown, reverse genetics-derived influenza A virus manufactured to conduct clinical trials that involve controlled human infection with influenza A virus. This influenza human challenge virus was produced for the National Institute of Allergy and Infectious Diseases (NIAID). The final Drug Product Live Influenza Virus RG-A/Texas/71/2017 (H3N2) (Lot #1507-232149) vial contains 1.86 X 106 median tissue culture infectious doses (TCID50)/mL formulated in 1X sucrose-phosphate-glutamate (SPG; 7.4% sucrose, 3.8 mM KH2PO4, 7.2 mM K2HPO4, 5.4 mM L-glutamic acid) in Ex-Cellä 293 serum-free medium (Sigma-Aldrich). It is susceptible to the FDA-approved neuraminidase (NA) inhibitors (NAI) oseltamivir phosphate, zanamivir, and peramivir, and the polymerase acidic (PA) inhibitor (PAI) baloxavir marboxil.x

Study Details

This study is designed to help us better understand how the immune system responds to the flu and how flu is transmitted in the environment. The ultimate goal is to develop better vaccines and drugs to protect against or fight the flu. This study will describe how the body's immune system responds to the flu virus during and after infection and how the flu virus is transmitted in the environment. The study will use a flu virus called A/Texas/71/2017 (H3N2), clade 3C3a produced specifically for clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy participants. Mild to moderate symptoms are expected based on previous studies with this strain of influenza. Study volunteers will be recruited and screened from the general population of metro Atlanta through advertisements or identified from a database of research participants who have previously agreed to be contacted for future research studies. Participants will provide written consent before study participation. Up to 200 healthy adults, 18-49 years old, will be screened for participation. Eligible participants will take part in the study over 5 months. Enrolled participants will be admitted to Emory University Hospital during which time they will receive the influenza virus in the form of a spray in the nose or exposure to infected participants followed by an 8-12 day inpatient stay for observation. Follow-up outpatient visits will take place at the Hope Clinic of the Emory Vaccine Center. Participants will receive compensation (pro-rated for all visits completed) for their time and effort. There will be no costs to participants as a result of being in the study.

Key Dates

Start date
Feb 4, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Live Influenza Virus RG-A/Texas/71/2017 (H3N2
    Participants will be pre-screened up to sixty days before the challenge study to identify baseline HAI titer. Participants will either be in the intranasal challenge or the natural exposure cohort.

Primary Outcome Measure

Number of participants with mild to moderate influenza disease [ Time Frame: Up to Day 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University Hospital Clinical Research NetworkAtlantaGeorgia30322-
Hope ClinicAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By research site
Emory University Hospital Clinical Research Network· Atlanta, GAHope Clinic· Atlanta, GA

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