Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers (SLVP032)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone®; FluMist®
Intervention description: quadrivalent, inactivated influenza virus vaccine, intramuscular; quadrivalent, live, attenuated influenza vaccine, intranasal spray
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: 3-5 participants will receive quadrivalent inactivated flu (IIV4) vaccine as a pilot study to establish protocols for immune cell isolation. Once the pilot study ends, all new participants will receive live, attenuated influenza vaccine and IIV4 will no longer be utilitzed.
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Quadrivalent inactivated influenza vaccine; Quadrivalent live, attenuated influenza vaccine; Adults with obstructive sleep apnea

Summary:

      The investigators collected blood and lymphoid tissues routinely discarded during surgery
      from adults after a routine seasonal influenza vaccination to determine how immune memory
      develops at the actual site of infection, and how immunization may alter this process.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Generally healthy 18-49 year old male and female patients undergoing tonsillectomy for
             obstructive sleep apnea.

          2. Willing to complete the informed consent process

          3. Availability for follow-up for the planned duration of the study

          4. Acceptable medical history by review of inclusion/exclusion criteria

        Exclusion Criteria:

          1. Prior off-study vaccination with seasonal influenza vaccine within three months of
             study vaccination

          2. Life-threatening reactions to previous influenza vaccinations

          3. Asthma (contraindication for receipt of LAIV4) for study volunteers; not a
             contraindication for enrolling as a pilot phase volunteer receiving IIV4.

          4. Allergy to egg or egg products or to vaccine components (including gentamicin,
             gelatin, arginine or MSG for participants receiving LAIV4).

          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; may include significant liver
             disease, diabetes mellitus treated with insulin or moderate to severe renal disease

          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 systemic
             glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible).
             Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review
             by the investigator.

         11. Participants who care for severely immunosuppressed persons that require a protective
             environment should not receive LAIV, or should avoid contact with such persons for 7
             days after receipt, given the theoretical risk for transmission of the live attenuated
             vaccine virus to close contacts. [If yes, may be ineligible]

         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 (except up to 325 mg. per day), Plavix, or Aggrenox will be
             reviewed by investigators to determine if study participation would affect the
             volunteer's safety or compliance with the protocol.

         16. Has taken an influenza antiviral medication within 48 hours prior to study vaccination
             [For volunteers receiving LAIV; If yes, may not eligible if unable to schedule at an
             appropriate interval].

         17. Receipt of blood or blood products within the past 6 months or planned use during the
             study.

         18. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

         19. Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned
             vaccinations prior to completion of last study visit (~ 14 days after study
             vaccination)

         20. Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned
             vaccination prior to completion of last study visit (~ 14 days after study enrollment)

         21. Need for allergy immunization (that cannot be postponed) until after the last study
             visit.

         22. History of Guillain-Barré syndrome

         23. Pregnant woman;

         24. Breastfeeding woman [if volunteer will receive LAIV4]

         25. Use of investigational agents within 30 days prior to enrollment or planned use during
             the study.

         26. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or
             donation of platelets within 2 weeks of enrollment or planned donation prior to
             completion of the last visit.

         27. 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.