Screening Volunteers for Influenza Challenge Studies

• INCLUSION CRITERIA:

  1. Greater than or equal to 18 and less than or equal to 50 years old, and have no significant health abnormalities
  2. Willing to consider taking part in a future influenza challenge study
  3. Non-habitual smoker (habitual smokers are persons who smoke more than 4 cigarettes or other tobacco products on a weekly basis) and agree to not use tobacco products during participation in any future influenza challenge study
  4. A female subject is eligible for this study if she is any of the following:
• Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are post-menopausal, as defined by no menses in greater than or equal to 1 year)
• Of childbearing potential but agrees to practice effective contraception or abstinence (from heterosexual sex) for 4 weeks prior to enrolling into a specific challenge study and during the study.

NOTE: Acceptable methods of contraception may include one or more of the following: 1) male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject; 2) implants of levonorgestrel; 3) injectable progestogen;, 4) an intrauterine device with a documented failure rate of less than 1percent; 5) oral contraceptives; or 6) double barrier methods including diaphragm or condom with a spermicide.

5. Willing to have samples stored for future research

EXCLUSION CRITERIA:

1. Self-reported history of any significant medical condition including but not limited to:

   • Chronic pulmonary disease (such as asthma, emphysema)
   • Chronic cardiovascular disease (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 (diabetes mellitus, renal dysfunction, hemoglobinopathies)
   • Immunosuppression or cancer
   • Neurological and neuro-developmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures)
   • Drug and/or alcohol dependency and/or abuse

2. Individuals with close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:

   Persons 65 years of age or older

   Children less than 5 years of age

   Residents of nursing homes

   Close contacts 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)
   • Neurological and neuro-developmental conditions (e.g. cerebral palsy, epilepsy, stroke, seizures, etc.)
   • Contacts who require medical follow-up or hospitalization during the past 5 years because of chronic disease (e.g. diabetes mellitus, renal dysfunction, hemoglobinopathies)
   • Immunosuppression or cancer
   • Children and teenagers who are receiving long-term aspirin therapy
   • Women who are pregnant or trying to become pregnant or are breast feeding

3. Known allergy to any of the following:

   • Treatments for influenza (i.e., oseltamivir, nonsteroidals)
   • Antibiotics in two or more classes of antibiotics (i.e., beta-lactams, cephalosporins, fluoroquinolones or glycopeptides [e.g. vancomycin])
4. Any condition that, in the judgment of the Principal Investigator, is a contraindication to protocol participation or impairs the volunteer's ability to give informed consent