T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone® (intramuscular); FluMist® (intranasal)
Intervention description: Licensed seasonal trivalent inactivated influenza vaccine (IIV3); Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 8 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccines; healthy participants; immunity to influenza; identical twins; fraternal twins; non-twins

Summary:

      This study will compare influenza vaccine responses in monozygotic and dizygotic twins.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Otherwise healthy, ambulatory children or adults, ages 8-17 years (identical twin
             pairs), 18-30 years (identical or fraternal twin pairs), 40-49 years (identical or
             fraternal twin pairs) or 70-100 years (twin or 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 and vital signs.

          5. Negative urine pregnancy test for women of childbearing potential

          6. If the subject is female and of childbearing potential, she must use an acceptable
             method of contraception and not become pregnant for the duration of the study.
             (Acceptable contraception includes implants, injectables, combined oral
             contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a
             vasectomized partner).

        Exclusion Criteria:

          1. Prior vaccination with TIV or LAIV in Fall 2009

          2. Allergy to egg or egg products, or to vaccine components, including gentamicin,
             gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only).

          3. Life-threatening reactions to previous influenza vaccinations

          4. Asthma (LAIV groups only)

          5. Active systemic or serious concurrent illness, including febrile illness on the day of
             vaccination

          6. History of immune deficiency

          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, blood pressure >150/95 at screening, or any other chronic
             disorder which, in the opinion of the investigator, might jeopardize volunteer safety
             or compliance with the protocol.

          8. Hospitalization in the past year for congestive heart failure or emphysema.

          9. Chronic Hepatitis B or C

         10. Recent or current use of immunosuppressive medication, including glucocorticoids
             (corticosteroid nasal sprays are permissible).

         11. Subjects in close contact with anyone who has a severely weakened immune system should
             not receive LAIV.

         12. 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).

         13. 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.

         14. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

         15. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
             agents such as aspirin, Plavix, Aggrenox may be acceptable after review by
             investigator.

         16. Receipt of blood or blood products within the past 6 months

         17. Medical or psychiatric condition or occupational responsibilities that preclude
             subject compliance with the protocol

         18. Inactivated vaccine 14 days prior to vaccination

         19. Live, attenuated vaccine within 60 days of vaccination

         20. History of Guillain-Barre Syndrome

         21. Pregnant or lactating woman

         22. Use of investigational agents within 30 days prior to enrollment

         23. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

         24. 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.