H1N1v Virus Challenge Study in Healthy Subjects

Exclusion Criteria

• •11. Does not have an ongoing symptomatic condition\* for which subject has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan.
• •\*e.g., ongoing fatigue without a diagnosis for symptom.
• •12. Vital signs as follows: pulse is 47 to 99 beats per minute, inclusive; systolic blood pressure is 85 to 139 mmHg, inclusive; diastolic blood pressure is 55 to 89 mmHg, inclusive; SpO2 \>95%; RR\<18; oral temperature is less than 100.0 Degrees Fahrenheit.
• •13. Eligibility laboratory values (White Blood Cell (WBC), Absolute Lymphocyte Count, Hemoglobin (Hgb), Platelets (PLTs), Alanine Transaminase (ALT) and Creatinine (Cr)) are within acceptable parameters.
• •14. Body mass index (BMI) \>18.5 and \<35 kg/m\^2 at screening.
• •15. 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.
• •16. Negative test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) at screening blood draw.
• •17. Negative respiratory virus panel by BIOFIRE(R) FILMARRAY(R) respiratory panel by bioMérieux or by Luminex xTAG (R) on Day (-2), and Day (-1).
• •1. 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.
• •2. 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.
• •3. 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.
• •4. Known allergy or intolerance to treatments for influenza (including but not limited to oseltamivir, baloxavir marboxil, acetaminophen).
• •5. Known allergy to two or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).
• •6. Known allergy to excipients in the challenge virus inoculum.
• •7. Receipt or planned receipt of any investigational drug/investigational vaccine/licensed vaccine within 30 days prior to the date of CHI.
• •8. Prior enrollment in any influenza virus challenge study.
• •9. Currently enrolled in any investigational study or intends to enroll in such a study within the ensuing study period.
• •10. Receipt of any influenza vaccine six months prior to challenge or plans to receive influenza vaccine within 60 days post-challenge.
• •11. History of a previous severe allergic reaction of any kind with generalized urticaria, angioedema, or anaphylaxis.
• •12. Receipt of blood or blood products during the six months prior to the planned date of challenge.
• •13. History of blood donation during the two months prior to the planned date of challenge and or plans to donate blood for the duration of the study.
• •14. Any condition, to include medical and psychiatric conditions, that in the opinion of the Investigator, might interfere with the safety of the subject and/or study objectives.
• •15. Known close contact with anyone known to have influenza 7 days prior to challenge.
• •16. Acute medical condition with new prescription medication use in the last 30 days.
• •17. Significant abnormality altering the anatomy of the nose/nasopharynx\* clinically significant nasal deviation, or nasal/sinus surgery within 180 days prior to challenge.
• •\*Including significant nasal polyps.
• •18. History in the last five years of chronic or frequent intermittent sinusitis.
• •19. Recent history (180 days) of epistaxis or anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration.