B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone; FluMist
Intervention description: Influenza Virus Vaccine Suspension for Intramuscular Injection; Influenza Virus Vaccine Live, Intranasal Intranasal Spray
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 8 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inactivated influenza vaccine; Live, attenuated influenza vaccine; Child identical twins and non-twins; Young and elderly non-twin adults

Summary:

      In this exploratory study, investigators will be looking at immune response differences
      between age groups and between the two different influenza vaccines given to identical twins,
      vaccine-naive young adults and elderly participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy, ambulatory 8-17 year old identical twins, 8-30 year old non-twins, or 70-100
             year old elderly non-twin adults.

          2. Willing to complete the informed consent process.

          3. Availability for follow-up for the planned duration of the study at least 28 days
             after immunization.

          4. Acceptable medical history by medical history and vital signs.

        Exclusion Criteria:

          1. Prior vaccination with seasonal TIV or LAIV or H1N1.

          2. Prior off-study vaccination with the current seasonal TIV or LAIV

          3. Allergy to egg or egg products, or to vaccine components

          4. Life-threatening reactions to previous influenza vaccinations

          5. Asthma or history of wheezing

          6. Active systemic or serious concurrent illness, including febrile illness on the day of
             vaccination

          7. History of immunodeficiency (including HIV infection)

          8. 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.

          9. Blood pressure >150 systolic or >95 diastolic at first study visit

         10. Hospitalization in the past year for congestive heart failure or emphysema.

         11. Chronic Hepatitis B or C.

         12. 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 except for non-LAIV Group C only).
             Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable for
             volunteers 70-100 yrs of age after review by the investigator.

         13. Participants in close contact with anyone who has a severely weakened immune system
             should not receive LAIV (Groups A and B only)

         14. 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).

         15. 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.

         16. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

         17. 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

         19. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

         20. Inactivated vaccine 14 days prior to vaccination

         21. Live, attenuated vaccine within 60 days of vaccination

         22. History of Guillain-Barré Syndrome

         23. Pregnant or lactating woman

         24. Use of investigational agents within 30 days prior to enrollment

         25. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

         26. 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.