Trial Search Results

Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Stanford Investigator(s):

Intervention(s):

  • Biological: 2011-2012 Fluzone IIV3 (IM)

Phase:

Phase 4

Eligibility


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.

Ages Eligible for Study

18 Years - 30 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting