Single Ascending Dose Challenge Study to Determine Safety and Reactogenicity of an Influenza Challenge Virus

Inclusion Criteria

• Healthy, as determined by medical history, physical examination, vital signs, echocardiogram, 12-lead ECG, and clinical safety laboratory examinations at baseline, as determined by the Investigator.
• Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by an HAI titer of ≤10 prior to challenge.
• Non-smoker (no smoking within the last year and a history of less than 10 packs per year total) and agree to not use tobacco products during participation in the study.
• Female subjects of childbearing potential must:
• Not be breastfeeding
• Have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1
• Will use oral, implantable, transdermal, or injectable contraceptives for 30 days prior to administration of the A/California/H1N1 2009 virus until the follow-up visit is performed.
• Use another reliable form of contraception approved by the Investigator (eg, intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) from the time of screening until the follow-up visit is performed.
• Female subjects not of childbearing potential must:
• Be at least 1 year post-menopausal, or
• Be surgically sterile
• Male subjects able to father a child and sexually active with a female of childbearing potential, must agree to use a double barrier method of birth control (eg, condom with spermicidal foam, cream gel) and to not donate sperm during the study, from the day of enrollment until the Day 60 (±3) follow-up visit. If the female partner is using an effective method of contraception, a single barrier method of birth control for the male is acceptable.
• Comprehension of the study requirements, expressed availability for the required study period, and ability to be quarantined for up to 10 days and to attend the scheduled follow up visit.
• Negative alcohol and urine drug screening tests prior to entering quarantine.
• Being willing to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria

• Prior receipt of any influenza vaccine within the previous 2 years.
• Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition such as chronic sinusitis.
• Abnormal nasal structure including septal deviation and nasal polyps, or surgery to the nose or nasopharynx within 6 months of signing the informed consent form or recent (within the last 6 months) history of frequent or prolonged episodes of epistaxis.
• Suffering from asthma, bronchiectasis, emphysema, chronic obstructive pulmonary disease or any other chronic lung disease. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. Subjects with a single episode of wheezing after age 12 (lasting less than 8 weeks) can be included at the investigator's discretion.
• A female who is pregnant or who is breast feeding
• Diastolic BP, systolic BP or, pulse not consistent with normal vital signs, based on investigator judgment.
• Current use or use of intranasal corticosteroids within the last 30 days prior to the administration of the investigational virus product (Study Day 1).
• Presence of significant uncontrolled medical, neurological or psychiatric illness (acute or chronic) as assessed by the Investigator. This includes, but is not limited to, institution of new surgical or medical treatment for a chronic condition), or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed on Day -1 prior to challenge.
• Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies.
• Cancer or treatment for cancer, within 5 years, excluding basal cell carcinoma of the skin, which is allowed.
• Presence of immunosuppre