The Human Mucosal Immune Responses to Influenza Virus (SLVP026)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone®; FluMist®
Intervention description: Influenza Virus Vaccine Suspension for Intramuscular Injection; 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: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trivalent, inactivated influenza vaccine; Live, attenuated influenza vaccine; Nasopharyngeal swabs; Young adults

Summary:

      This study will examine the immune responses to the seasonal influenza vaccine in single
      cells of the nasal passages when compared with cells in circulating blood.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Otherwise healthy, ambulatory adult between the ages of 18-30 years

          2. Willing to complete the informed consent process.

          3. Availability for follow-up at Day 2 (LAIV Group only)

          4. Acceptable medical history by review of inclusion/exclusion criteria and vital signs.

        Exclusion Criteria:

          1. Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV

          2. Allergy to egg or egg products, or to vaccine components, including thimerosal (TIV
             multidose vials only), or gentamicin, gelatin, arginine or MSG (for LAIV only).

          3. Life-threatening reactions to previous influenza vaccinations

          4. Asthma or history of wheezing (except for controls in the study who will be assigned
             to receive TIV).

          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

          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 for allergies and topical steroids are
             permissible. Inhaled steroids for conditions such as asthma are not permissible for
             volunteers in the LAIV group.

         12. Participants in close contact with anyone who has a severely weakened immune system
             should not receive LAIV (LAIV Group only).

         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. aspirin per day), Plavix, or Aggrenox
             must be reviewed by investigator to determine if this would affect the volunteer's
             safety..

         17. Receipt of blood or blood products within the past 6 months of planned used during the
             study.

         18. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

         19. Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination
             prior to completion of the last study visit.

         20. Live, attenuated vaccine within 60 days of vaccination or planned non-study
             vaccination prior to completion of the last study visit.

         21. History of Guillain-Barré Syndrome

         22. Pregnant or lactating woman

         23. Use of investigational agents within 30 days prior to enrollment or planned use of
             investigational agents prior to completion of study visits.

         24. 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.

         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.