Innate and Acquired Immunity to Influenza Infection and Immunization (SLVP029)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone®; FluMist®
Intervention description: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine; FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 6 Months
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inactivated influenza vaccine; Live, attenuated influenza vaccine; Young children; Adults

Summary:

      The purpose of the study is to get a better understanding of the natural and adaptive immune
      response to the flu virus and to compare the immune cell responses to FDA-licensed flu
      vaccines in nasal mucosal cells and in blood.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Otherwise healthy, 6 mo-49 year-old volunteers.

          2. Willing to complete the informed consent process (including assent for minors 7-17
             years of age).

          3. Availability for follow-up for the planned duration of the study.

          4. For parents of children 6 months - 4 years of age: Willing to participate in the study
             annually for up to 5 years (if yes, consider for annual return groups).

          5. Acceptable medical history by review of inclusion/exclusion criteria and vital signs.

          6. Influenza vaccine-naive or only one prior season of flu immunization with IIV (does
             not apply to Groups F and G).

        Exclusion Criteria:

          1. Prior off-study vaccination with the current year's seasonal influenza vaccine

          2. Receipt of LAIV in the prior season (does not apply to Groups F and G)

          3. Received flu immunizations in 2 or more prior flu seasons (does not apply to Groups F
             and G)

          4. Allergy to egg or egg products, or to vaccine components, (including gentamicin,
             gelatin, arginine or MSG if given LAIV4)

          5. Life-threatening reactions to previous influenza vaccinations

          6. Asthma in adults. Children aged 2 through 4 years who have asthma or who have had a
             wheezing episode noted in the medical record within the past 12 months, or for whom
             parents report that a health care provider stated that they had wheezing or asthma
             within the last 12 months [If yes, not eligible for LAIV Groups A, B, C, & F].

          7. Active systemic or serious concurrent illness, including febrile illness on the day of
             vaccination

          8. History of immunodeficiency (including HIV infection)

          9. For children or adolescents through 17 years of age,receiving aspirin therapy or
             aspirin-containing products [If yes, not eligible for LAIV Groups A, B, C, and F].

         10. 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.

         11. Blood pressure >150 systolic or >95 diastolic at first study visit and the day of
             vaccination (for children 12 yrs and older, and adults).

         12. Hospitalization in the past year for congestive heart failure or emphysema.

         13. Chronic Hepatitis B or C

         14. 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)

         15. Participants in close contact with anyone who has a severely weakened immune system
             and requires a protective environment. Exposure to such persons should be avoided for
             7 days after receipt of LAIV. [If yes, may be ineligible for Groups A,B, C and F].

         16. 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).

         17. 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

         18. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

         19. 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.

         20. Has taken an influenza antiviral medication within 48 hours prior to study vaccination
             [If yes, not eligible for LAIV Groups A, B, C and F].

         21. Receipt of blood or blood products within the past 6 months or planned used during the
             study

         22. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol.

         23. Receipt of inactivated vaccine 14 days prior to study enrollment, or planned
             vaccinations prior to completion of last study visit

         24. Receipt of live, attenuated vaccine within 60 days prior to enrollment of planned
             vaccination prior to completion of last study visit

         25. Need for allergy immunization (that cannot be postponed) during the study period

         26. History of Guillain-Barre syndrome

         27. Pregnant woman

         28. Breastfeeding [If yes, not eligible for LAIV Group F]

         29. Use of investigational agents within 30 days prior to enrollment or planned use during
             the study

         30. 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

         31. 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.