H1N1v Virus Challenge Study in Healthy Subjects

Inclusion Criteria

• Provide written informed consent prior to initiation of any study procedure.
• Are able to understand and comply with planned study procedures and be available for all study visits.
• Agree to remain an inpatient for at least seven days after challenge, and until they have no virus shedding,* determined by qualitative RT-PCR for a minimum of two consecutive days post-challenge.
• For a minimum of seven days post-challenge (Study Day 8).
• Healthy* males and non-pregnant, non-breastfeeding females**, aged >/= 18 and 95%; RR 18.5 and <35 kg/m^2 at screening.
• Other screening tests (ECG and CXR) are within normal reference range or not deemed clinically significant by the PI or appropriate sub-investigator*.

*Designated clinician licensed to make medical diagnoses and listed on the Form FDA 1572.

• Negative test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) at screening blood draw.
• Negative respiratory virus panel by BIOFIRE(R) FILMARRAY(R) respiratory panel by bioMérieux or by Luminex xTAG (R) on Day (-2), and Day (-1).

Exclusion Criteria

• Female subject who has a positive pregnancy test on screening or admission, is breastfeeding or planning to become pregnant from 30 days prior to challenge through the end of the study.
• Presence of self-reported or medically documented significant medical or psychiatric condition(s)*.

*Significant medical or psychiatric conditions include but are not limited to:

• Respiratory disease (e.g., chronic obstructive pulmonary disease (COPD), asthma) requiring daily medications (Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics) currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years
• Presence of any febrile illness or symptoms suggestive of a respiratory infection within two weeks prior to Controlled Human Infection (CHI).
• Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.
• Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, seizures, encephalopathy, focal neurologic deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis).
• Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell carcinoma of the skin, which is allowed.
• An autoimmune disease.
• An immunodeficiency of any cause.
• A history of diabetes.
• Presence of immunosuppression or any medications that may be associated with impaired immune responsiveness*.

*Including, but not limited to, corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids or other similar or toxic drugs during the preceding 12-month period prior to screening. Low dose topical and intranasal steroid preparations used for a discrete period of time are permitted.

• Known allergy or intolerance to treatments for influenza (including but not limited to oseltamivir, baloxavir marboxil, acetaminophen).
• Known allergy to two or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).
• Known allergy to excipients in the challenge virus inoculum.
• Receipt or planned receipt of any investigational drug/investigational vaccine/licensed vaccine within 30 days prior to the date of CHI.
• Prior enrollment in any influenza virus challenge study.
• Currently enrolled in any investigational study or intends to enroll in such a study within the ensuing study period.
• Receipt of any influenza vaccine six months prior to challenge or plans to receive influenza vaccine within 60 days post-challenge.
• History of a previous severe allergic reaction of any kind wi