Influenza Human Challenge Model Using H3N2 (A/Texas/71/2017 (H3N2), Clade 3C3a)
Emory University
Summary
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.
Description
Influenza A continues to circulate widely in the human population and causes significant morbidity and mortality. Current vaccines have variable effectiveness year-to-year, with observable breakthrough infections each season, and have limited effectiveness in certain at-risk members of the population. Although basic and clinical influenza research has broadened our understanding of viral immunology, transmission, and pathogenesis, important questions, particularly concerning correlates of protection, viral evolution, and transmission, remain unanswered. Many of these questions can only be appr…
Eligibility
- Age range
- 18–49 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Can understand and comply with all planned study procedures. * Healthy, non-pregnant, non-breast-feeding persons aged ≥18 and ≤49 years of age inclusive at the time of challenge. * Persons biologically able to become pregnant must be practicing abstinence or using an acceptable method of birth control for at least 30 days before the challenge through the duration of the trial. Persons biologically able to make someone pregnant must agree not to get their partner pregnant for the duration of the trial. * A person is considered of childbearing potential unless post-meno…
Interventions
- BiologicalInfluenza Virus influenza A H3N2 strain
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
Locations (2)
- Emory University Hospital Clinical Research NetworkAtlanta, Georgia
- Hope ClinicAtlanta, Georgia