Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection (SLVP031)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone®; FluMist®
Intervention description: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine); FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine)
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
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; Identical twin adults

Summary:

      The purpose of this study is provide a better understanding of the adaptive immune response
      to the licensed flu vaccines. The investigators hope the information learned from this study
      will help identify and describe important factors of influenza immunity especially of or
      specific proteins associated with the T-cell immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Otherwise healthy 18-49 years old identical (MZ) twins identified as DR1501+ or
             DR0701+ by lab assay results. Both twins in the pair must be willing to participate in
             the study.

          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 and vital signs.

        Exclusion Criteria:

          1. Prior off-study vaccination with the current year's seasonal influenza vaccine.

          2. Allergy to egg or egg products or to vaccine components including gentamicin, gelatin,
             arginine or MSG

          3. Life-threatening reactions to previous influenza vaccinations

          4. Asthma (a contraindication for receipt of 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, 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.

          8. Blood pressure >150 systolic or >95 diastolic at first study visit and the day of
             vaccination.

          9. Hospitalization in the past year for congestive heart failure or emphysema.

         10. Chronic Hepatitis B or C.

         11. 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)

         12. 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]

         13. 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).

         14. 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.

         15. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

         16. 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.

         17. Has taken an influenza antiviral medication within 48 hours prior to study vaccination
             [If yes, may not eligible if unable to schedule at an appropriate interval].

         18. Receipt of blood or blood products within the past 6 months or planned used during the
             study.

         19. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

         20. Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned
             vaccinations prior to completion of last study visit ( ~ 28 days after study
             vaccination)

         21. Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned
             vaccination prior to completion of last study visit (~ 28 days after study
             vaccination)

         22. Need for allergy immunization (that cannot be postponed) during the study period.

         23. History of Guillain-Barré syndrome

         24. Pregnant or lactating woman

         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
             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.