Trial Search Results
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 3, 2011
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
Stanford is currently not accepting patients for this trial.
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
- Biological: TIV
- Biological: High-Dose TIV
1. Otherwise healthy, ambulatory adults, ages 18-30 years (identical or fraternal twin
pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical
2. Willing to complete the informed consent process.
3. Availability for follow-up for the planned duration of the study at least 28 days
4. Acceptable medical history and vital signs.
1. Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live
attenuated influenza vaccine (LAIV) in Fall 2011
2. Allergy to egg or egg products, or to vaccine components, including thimerosal (if TIV
multidose vials used)
3. Allergy to latex (for Group F only - may be assigned to Fluzone High-Dose). Review
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. Blood pressure >150 systolic or > 95 diastolic at Visit 1
9. Hospitalization in the past year for congestive heart failure or emphysema.
10. Chronic Hepatitis B or C
11. Recent or current use of immunosuppressive medication, including glucocorticoids
(corticosteroid nasal sprays, topical steroids and inhaled steroids are permissible).
Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review
by the investigator.
12. 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).
13. 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
14. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
medical follow up or hospitalization during the preceding year
15. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
agents such as aspirin (except aspirin up to 325 mg.day), Plavix, or Aggrenox must be
reviewed by investigator to determine if this would affect the volunteer's safety.
16. Receipt of blood or blood products within the past 6 months
17. Medical or psychiatric condition or occupational responsibilities that preclude
participant compliance with the protocol
18. Inactivated vaccine 14 days prior to vaccination
19. Live, attenuated vaccine within 60 days of vaccination
20. History of Guillain-Barre Syndrome
21. Pregnant or lactating woman
22. Use of investigational agents within 30 days prior to enrollment
23. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
24. 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 - 100 Years
Genders Eligible for Study