T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: TIV; High-Dose TIV; LAIV
Intervention description: Influenza Virus Vaccine Suspension for Intramuscular Injection; High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe; Live, attenuated influenza vaccine for Intranasal Spray
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inactivated influenza vaccine; Live, attenuated influenza vaccine; Adult and elderly identical twins; Adult fraternal twins

Summary:

      This study will investigate markers, mechanisms and define general predictors for
      immunological health by comparing influenza vaccine responses in monozygotic and dizygotic
      twins.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Otherwise healthy, ambulatory adults, ages 18-30 years (identical or fraternal twin
             pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical
             twin pairs).

          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.

        Exclusion Criteria:

          1. Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live
             attenuated influenza vaccine (LAIV) in Fall 2012

          2. Allergy to egg or egg products, or to vaccine components (including gentamicin,
             gelatin, arginine or MSG (LAIV for Group B only), and thimerosal (if TIV multidose
             vials used)

          3. Life-threatening reactions to previous influenza vaccinations

          4. Active systemic or serious concurrent illness, including febrile illness the day of
             vaccination

          5. History of immunodeficiency (including HIV infection)

          6. 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.

          7. Blood pressure >150 systolic or > 95 diastolic at Visit 1

          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, topical steroids and inhaled steroids are permissible).
             Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review
             by the investigator.

         11. 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).

         12. 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.

         13. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

         14. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
             agents such as aspirin (except aspirin up to 325 mg.day), Plavix, or Aggrenox must be
             reviewed by investigator to determine if this would affect the volunteer's safety.

         15. Receipt of blood or blood products within the past 6 months or planned receipt of
             blood products prior to completion of study visits.

         16. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

         17. Receipt of inactivated vaccine 14 days prior to study vaccination, or planned
             non-study vaccination prior to completion of Visit 03 (~Day 28 after the study
             vaccination)

         18. Receipt of live, attenuated vaccine within 60 days of vaccination, or planned
             non-study vaccination prior to completion of Visit 03 (~Day 28 after the study
             vaccination)

         19. Need for allergy immunization (that cannot be postponed) during the study period V01
             to V03 (~Day 28)

         20. History of Guillain-Barre Syndrome

         21. Pregnant or lactating woman

         22. Use of investigational agents within 30 days prior to enrollment or planned use of
             investigational agents prior to completion of study visits.

         23. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or
             planned blood donation prior to completion of Visit 03 ( ~28 Day after study
             vaccination)

         24. A current member of the clinical study team.

         25. 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.

         26. Asthma or history of wheezing (for Group B volunteers only)

         27. Participants in close contact with anyone who has a severely weakened immune system
             should not receive LAIV (for Group B volunteers only)