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.
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
- Biological: 2011-2012 Fluzone IIV3 (IM)
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
3. Acceptable medical history by medical history and vital signs.
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
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
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