Genetic and Environmental Factors in the Response to Influenza Vaccination

Exclusion Criteria

• •1. Prior off-study vaccination with the current year's seasonal influenza vaccine.
• •2. Allergy to egg or egg products, or to vaccine components, (including gentamicin, gelatin, arginine or MSG in LAIV)
• •3. Life-threatening reactions to previous influenza vaccinations.
• •5. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination.
• •6. History of immunodeficiency (including HIV infection).
• •7. Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
• •8. Blood pressure \>150 systolic or \>95 diastolic at first study visit and the day of vaccination.
• •9. Hospitalization in the past year for congestive heart failure or emphysema.
• •10. Chronic Hepatitis B or C.
• •11. Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in all groups; inhaled steroid use is not permissible).
• •12. In close contact with anyone who has a severely weakened immune system and requires a protective environment (If yes, may be ineligible for Group C; exposure to such persons should be avoided for 7 days after receipt of LAIV).
• •13. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
• •14. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
• •15. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year.
• •16. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
• •18. Receipt of blood or blood products within the past 6 months or planned used during the study.
• •19. Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol.
• •20. Receipt of inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last study visit (\~ 28 days after study vaccination).
• •21. Receipt of live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (\~ 28 days after study vaccination).
• •22. Need for allergy immunization (that cannot be postponed) during the study period.
• •24. History of Guillain-Barré syndrome
• •25. Pregnant woman
• •27. Use of investigational agents within 30 days prior to enrollment or planned use during the study.
• •28. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned donation prior to completion of the last visit.
• •29. Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.