Influenza A 2009 H1N1 Challenge Study in Healthy Adults

-INCLUSION CRITERIA:

• Greater than or equal to 18 and less than or equal to 50 years of age.
• Agrees to not use tobacco products during participation in this study.
• Willingness to remain in isolation for the duration of viral shedding (at a minimum 9 days) and to comply with all study requirements.
• A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following:
• Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
• Of childbearing potential but agrees to practice effective contraception or abstinence for 4 weeks prior to and 8 weeks after administration of the influenza challenge virus. Acceptable methods of contraception include 1 or more of the following: 1) male partner who is sterile prior to the female participant s entry into the study and is the sole sexual partner for the female participant; 2) implants of levonorgestrel; 3) injectable progestogen; 4) an intrauterine device with a documented failure rate of < 1%; 5) oral contraceptives; and 6) double barrier methods including diaphragm or condom with a spermicide.
• Willing to have samples stored for future research.
• Prechallenge serum hemagglutination-inhibition titer against the challenge strain of 1:16 or less.
• HIV uninfected.

EXCLUSION CRITERIA

• Presence of self-reported or medically documented significant medical condition including but not limited to:
• Chronic pulmonary disease (e.g., asthma, emphysema).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression or ongoing malignancy.
• Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• Postinfectious or postvaccine neurological sequelae.
• Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
• Persons greater than or equal to 65 years of age.
• Children < 5 years of age.
• Residents of nursing homes.
• Persons of any age with significant chronic medical conditions such as:
• Chronic pulmonary disease (e.g., asthma).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Contacts who required medical follow-up or hospitalization during the past 5 years because of chronic metabolic disease (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression or cancer.
• Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• Children and teenagers who are receiving long-term aspirin therapy.
• Women who are pregnant or who are trying to become pregnant.
• Individual with body mass index (BMI) less than or equal to 18.5 and greater than or equal to 40.
• Smokes more than 4 cigarettes or other tobacco products on weekly basis.
• Complete blood count (CBC) with differential outside of the NIH Department of Laboratory Medicine (DLM) normal reference range and deemed clinically significant by the PI.
• Chemistries in the acute care, mineral, and/or hepatic panels, and/or any of the following: lactate dehydrogenase, uric acid, creatine kinase, and total protein outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
• Urinalysis outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
• Clinically significant abnormality on electrocardiogram .
• Clinically significant abnormality as deemed by the PI on echocardiographic testing.
• Recent acute illness within 1 week of admission to the isolation fac