Intranasal challenge of healthy adults with Respiratory Syncytial Virus (RSV)

Exclusion Criteria

• Current medical conditions as follows:
• 1) Clinical evidence of chronic pulmonary disease or any use of a bronchodilator or other asthma medication.
• 2) Current smoker unwilling/unable to desist for the quarantine phase of the study.
• 3) History or clinical evidence of recurrent lower respiratory tract infection.
• 4) Evidence of infection with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) by serology.
• Medical history as follows:
• 5) History of immunodeficiency.
• 6) History of chronic sinusitis.
• 7) History of frequent epistaxis.
• 8) History of or current diagnosis of diabetes.
• 9) Prior/concomitant therapy including
• • Receipt of any systemic chemotherapeutic agent at any time;
• • Receipt of systemic glucocorticoids within 1 month, or any other immunosuppressive drug within 6 months prior to challenge.
• • Receipt of any investigational drug within 6 months prior to dose or concurrent enrolment in another clinical study.
• • Prior participation in a clinical trial of any experimental RSV viral challenge delivered directly to the respiratory tract at any time, or any other respiratory virus challenge within 1 year prior to dose.
• 10) Nursing mother.
• 11) Alcohol or drug addiction/abuse within the past 2 years.
• 12) A positive urine Class A drug or alcohol screen unless there is a medical reason.
• 13) History of seasonal hay fever or seasonal allergies.
• 14) Employees of the clinical study site or sponsor, any other individuals involved with the conduct of the study, or immediate family members of such individuals.
• 15) Health care workers anticipated to have patient contact within 2 weeks after viral challenge.
• 16)Participants who, for an additional 2 weeks after discharge from the isolation facility, are likely to have contact with a household member or close contact with someone who is: (a) less than 3 years of age; (b) any person with any known immunodeficiency; (c) any person receiving immunosuppressant medications; (d) any person undergoing or soon to
• undergo cancer chemotherapy within 28 days of challenge; (e) any person who has diagnosed emphysema or COPD, is elderly residing in a nursing home, or with severe lung disease or medical condition; or (f) any person who has received a transplant (bone marrow or solid organ).
• 17) As a result of the medical interview, physical examination, or screening investigations, the investigator(s) considers the participant unfit for the study.