Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: 2011-2012 Fluzone IIV3 (IM)
Intervention description: 2011-2012 Fluzone IIV3 vaccine delivered intramuscularly (IM)
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza Vaccine

Summary:

      The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in
      healthy young adults by vaccinating participants and obtaining blood samples at designated
      time points before and after vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Otherwise healthy, 18-30 year old young adult.

          2. Availability for follow-up for the planned duration of the study at least 180 days
             after immunization.

          3. Acceptable medical history by medical history and vital signs.

        Exclusion Criteria:

          1. Prior vaccination with 2010-2011 seasonal TIV or LAIV.

          2. Prior off-study vaccination with the current 2011-2012 seasonal TIV or LAIV

          3. Weight less than 110 pounds.

          4. Allergy to egg or egg products, or to vaccine components, including gelatin or
             thimerosal (thimerosal in TIV multidose vials only).

          5. Life-threatening reactions to previous influenza vaccinations

          6. Active systemic or serious concurrent illness, including febrile illness on the day of
             vaccination

          7. History of immunodeficiency (including HIV infection)

          8. 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.

          9. Blood pressure >150 systolic or >95 diastolic at first study visit

         10. Hospitalization in the past year for congestive heart failure or emphysema.

         11. Chronic Hepatitis B or C.

         12. Recent or current use of immunosuppressive medication, including systemic
             glucocorticoids. Corticosteroid nasal sprays and topical steroids are permissible.

         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. Receipt of blood or blood products within the past 6 months.

         18. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

         19. Receipt of inactivated vaccine 14 days prior to study enrollment, planned vaccinations
             prior to completion of Visit 09 (Day 28 after study vaccination), or planned
             vaccination 14 days prior to Visit 10 (6 months after study vaccination).

         20. Receipt of live, attenuated vaccine 60 days prior to study enrollment, planned
             vaccination prior to completion of Visit 09 (Day 28 after study vaccination), or
             planned vaccination 14 days prior to Visit 10 (6 months after study vaccination).

         21. History of Guillain-Barré Syndrome

         22. Pregnant or lactating woman

         23. Use of investigational agents within 30 days prior to study enrollment or planned use
             during the study period.

         24. Donation of the equivalent of a unit of blood within 6 weeks prior to study
             enrollment, or during the first 5 weeks of study participation.

         25. A member of the study team or their family member, to include investigators, research
             laboratory staff, clinical research staff.

         26. 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.