Influenza Human Challenge Model Using H3N2 (A/Texas/71/2017 (H3N2), Clade 3C3a)
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.
• 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-menopausal (absence of menses for ≥1 year) or surgically sterilized (tubal ligation/salpingectomy, bilateral oophorectomy, or hysterectomy).
⁃ Acceptable contraception methods for persons of childbearing potential include but are not limited to: sexual abstinence from intercourse with partners biologically able to make them pregnant, monogamous relationship with a vasectomized partner, barrier methods such as condoms or diaphragms with spermicide or foam, effective devices (IUDs, NuvaRing®) or licensed hormonal products such as implants, injectables or oral contraceptives.
• Persons of childbearing potential must have a negative serum or urine pregnancy test at screening and a negative urine pregnancy test within 24 hours before challenge.
• Are in good general health, as determined by the study investigator within 30 days of challenge, and do not have any of the following conditions:
‣ Chronic pulmonary disease (e.g., asthma or emphysema).
⁃ Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
⁃ Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathies).
⁃ Immunosuppression, ongoing malignancy, or history of malignancy (excluding non-melanotic skin cancer in remission without treatment for more than 5 years).
⁃ Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
⁃ History of postinfectious or postvaccine neurological sequelae.
⁃ Autoimmune, inflammatory, vasculitis, or rheumatic disease, including but not limited to systemic lupus erythematosus, polymyalgia rheumatica, rheumatoid arthritis, or scleroderma.
• Demonstrate knowledge and comprehension of the study by scoring ≥70% on a quiz on the study protocol and policies.
• Agrees to not use cigarettes, e-cigarettes, marijuana, or other tobacco products during the quarantine period.
• Agrees not to use prescription or over-the-counter medications that could impact influenza challenge efficacy or symptoms (including oseltamivir, zanamivir, peramivir, baloxavir marboxil, amantadine and rimantadine, aspirin, intranasal steroids, acetaminophen, decongestants, antihistamines, and other NSAIDs), within 14 days before challenge and through the quarantine period, unless approved by the investigator.