Evaluation of Anti-Hemagglutinin (Anti-HA) Antibodies as Protection From the Flu in Healthy People

Inclusion Criteria

• •1. Greater than or equal to 18 and less than or equal to 50 years of age.
• •2. Agrees to not use tobacco products during participation in this study.
• •3. Willingness to remain in isolation for the duration of viral shedding (at a minimum 9 days) and to comply with all study requirements.
• •4. A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following:
• •* Of nonchildbearing 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.
• •5. Willing to have samples stored for future research.
• •6. Prechallenge serum hemagglutination inhibition (HAI) titer against the challenge virus of greater than or equal to 1:40 or less than or equal to 1:10 during a screening visit in protocol #11-I-0183
• •7. HIV uninfected.
• •EXCLUSION CRITEIRA:
• •1. Presence of self-reported or medically documented significant medical condition including but not limited to:
• •1. Chronic pulmonary disease (e.g., asthma, emphysema).
• •2. Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• •3. Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathies).
• •4. Immunosuppression or ongoing malignancy.
• •5. Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• •6. Postinfectious or postvaccine neurological sequelae.
• •2. Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
• •1. Persons greater than or equal to 65 years of age.
• •2. Children less than or equal to 5 years of age.
• •3. Residents of nursing homes.
• •4. 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).
• •* Individuals who are receiving long-term aspirin therapy.
• •* Women who are pregnant or who are trying to become pregnant.
• •3. Individual with body mass index (BMI) less than or equal to 18.5 and greater than or equal to 40.
• •4. Smokes more than 4 cigarettes or other tobacco products on weekly basis.
• •5. Complete blood count (CBC) with differential outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
• •6. 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.
• •7. Neutropenia below 1,500 cells/mm(3) (Grade 2 or greater)
• •8. Urinalysis outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
• •9. Clinically significant abnormality on electrocardiogram.
• •10. Clinically significant abnormality as deemed by the PI on echocardiographic testing.
• •11. Clinically significant abnormality as deemed by the PI on the Pulmonary Function Test (PFT).
• •12. Recent acute illness within 1 week of admission to the isolation facility.
• •13. Known allergy to treatments for influenza (including but not limited to oseltamivir, nonsteroidals).
• •14. Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).
• •15. Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
• •16. Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
• •17. Receipt of any non-influenza related unlicensed vaccine within 6 months prior to enrollment.
• •18. Self-reported or known history of current alcoholism or drug abuse, or positive urine/serum test for drugs of abuse (i.e., amphetamines, cocaine, benzodiazepines, opiates, or metabolites, but not tetrahydrocannabinol (THC) or metabolites).
• •19. Self-reported or known history of psychiatric or psychological issues deemed by the PI to be a contraindication to protocol participation
• •20. Known close contact with anyone known to have influenza in the past 7 days.
• •21. Any condition or event that, in the judgment of the PI, is a contraindication to protocol participation or impairs the volunteer s ability to give informed consent.