B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)
B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)
In this exploratory study, investigators will be looking at immune response differences
 between age groups and between the two different influenza vaccines given to identical twins,
 vaccine-naive young adults and elderly participants.
This is an exploratory study of healthy children and adults who are given either standard
 trivalent, inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV).
 There are no exclusions for gender, ethnicity or race. Following confirmation of written
 informed consent, baseline blood samples will be drawn from all study participants prior to
 immunization. The volunteers enrolled in any the three groups (A,B,C) cannot have been
 immunized with previous year's seasonal influenza vaccine. The identical twins in Groups A
 will be randomized to each receive a different vaccine (TIV or LAIV) than their twin. The
 non-twin children in Group B will also be randomly assigned to receive either TIV or LAIV.
 Non-twin elderly adults in Group C will be given standard TIV. All participants will receive
 a single dose of their assigned influenza vaccine, either by intramuscular (IM) injection
 (TIV) or intranasal application (LAIV).
Inclusion Criteria:

 1. Healthy, ambulatory 8-17 year old identical twins, 8-30 year old non-twins, or 70-100
 year old elderly non-twin adults.

 2. Willing to complete the informed consent process.

 3. Availability for follow-up for the planned duration of the study at least 28 days
 after immunization.

 4. Acceptable medical history by medical history and vital signs.

 Exclusion Criteria:

 1. Prior vaccination with seasonal TIV or LAIV or H1N1.

 2. Prior off-study vaccination with the current seasonal TIV or LAIV

 3. Allergy to egg or egg products, or to vaccine components

 4. Life-threatening reactions to previous influenza vaccinations

 5. Asthma or history of wheezing

 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 in
 all groups; inhaled steroid use is not permissible except for non-LAIV Group C only).
 Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable for
 volunteers 70-100 yrs of age after review by the investigator.

 13. Participants in close contact with anyone who has a severely weakened immune system
 should not receive LAIV (Groups A and B only)

 14. 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).

 15. 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.

 16. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
 medical follow up or hospitalization during the preceding year

 17. 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.

 18. Receipt of blood or blood products within the past 6 months

 19. Medical or psychiatric condition or occupational responsibilities that preclude
 participant compliance with the protocol

 20. Inactivated vaccine 14 days prior to vaccination

 21. Live, attenuated vaccine within 60 days of vaccination

 22. History of Guillain-Barré Syndrome

 23. Pregnant or lactating woman

 24. Use of investigational agents within 30 days prior to enrollment

 25. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

 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.