Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model

Inclusion Criteria

• In good health with no history of major medical conditions.
• A total body weight ≥ 50 kg and a BMI of >18.
• Acceptable forms of effective contraception.
• An informed consent document signed and dated by the subject and Investigator.
• Sero-suitable for Challenge Virus.

Exclusion Criteria

• Subjects who have a significant history of any tobacco use at any time (≥ total 10 pack year history, e.g. one pack a day for 10 years).
• Subjects who have been pregnant within six months prior to the study, or who have a positive pregnancy test at any point in the study.
• Any history or evidence of any clinically significant medical conditions (cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychotic, renal, and/or other major disease or malignancy).
• History or evidence of autoimmune disease or known immunodeficiency of any cause.
• Subjects with any history of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology.
• Positive human immunodeficiency virus (HIV), Hepatitis A (HAV), B (HBV), or C (HCV) test.
• Any significant abnormality altering the anatomy of the nose or nasopharynx.
• Any clinically significant history of epistaxis (nose bleeds).
• Any nasal or sinus surgery within six months of inoculation.
• Recurrent history of clinically significant autonomic dysfunction.
• Any abnormal laboratory test or ECG.
• Confirmed positive test for drugs of abuse.
• Venous access deemed inadequate for the phlebotomy and cannulation.
• Any known allergies to the excipients in the Challenge Virus inoculums.
• Health care workers who work in units with severely immuno-compromised patients.
• Evidence of vaccinations within the four weeks prior to Human Viral Challenge or intention to receive travel vaccination before the last study visit.
• Receipt of blood or blood products, or loss (including blood donations) of 450 mL or more of blood, during the 3 months prior to inoculations.
• Presence of significant respiratory symptoms existing on the day of challenge or between admission to the unit and inoculation with virus.
• History suggestive of respiratory infection within 14 days prior to admission to the unit.
• Use within 28 days prior to Human Viral Challenge (Day 0) of nasal steroids * Use within seven days of any other medication or product (prescription or over-the-counter), for symptoms of hay fever, rhinitis, nasal congestion or respiratory tract infection.
• Receipt of systemic: glucocorticoids, antiviral drugs, or immunoglobulins (Igs) or any other cytotoxic or immunosuppressive drug.
• Receipt of any systemic chemotherapy agent at any time.