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B-cell Immunity to Influenza (SLVP017)- Year 5, 2013
Trial ID: NCT03020537
In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different vaccines given to identical twins and vaccine-naive young adults.
U19 Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire- Year 5, 2013
1. Healthy, ambulatory children 1-2 years of age or 18-30 year-old young adults.
2. Willing to complete the informed consent process.
3. Availability for follow-up for the planned duration of the study (after last study
immunization, approximately 8 weeks for Group A and 4 weeks for Group B).
4. Acceptable medical history by medical history and vital signs.
1. Group A: Prior vaccination with a seasonal flu vaccine (IIV). Group B: Prior
vaccination with the 2012-2013 seasonal flu vaccine (IIV or LAIV).
2. Prior off-study vaccination with the current 2013-2014 seasonal IIV or LAIV
3. Allergy to egg or egg products, or to vaccine components.
4. Life-threatening reactions to previous influenza vaccinations
5. Active systemic or serious concurrent illness, including febrile illness on the day of
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. Chronic Hepatitis B or C.
9. Recent or current use of immunosuppressive medication, including systemic
glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible; use
of inhaled steroids, or oral steroids (<20mg prednisone-equivalent/day), may be
acceptable after review by the investigator.
10. 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).
11. 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
12. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
medical follow up or hospitalization during the preceding year
13. 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.
14. Receipt of blood or blood products within the past 6 months
15. Medical or psychiatric condition or occupational responsibilities that preclude
participant compliance with the protocol
16. Inactivated vaccine within 14 days prior to study vaccination (inform study staff of
any non-study vaccinations received during study period)
17. Live, attenuated vaccine within 30 days prior to first study vaccination, or planned
immunization with a live, attenuated vaccine before completion of study visits (inform
study staff of any non-study vaccinations received during study period).
18. Need for allergy immunizations (that cannot be rescheduled if necessary) during the
19. History of Guillain-Barre Syndrome
20. Pregnant or lactating woman
21. Use of investigational agents within 30 days prior to enrollment or planned use of
investigational agents prior to completion of study visits
22. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
23. 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.
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