B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)

Not Recruiting

Trial ID: NCT03020498


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.

Official Title

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 - Years 2 (2010) & 3 (2011)

Stanford Investigator(s)


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

   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

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.


biological: Fluzone

biological: FluMist

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305