Trial Search Results
Genetic and Environmental Factors in the Response to Influenza Vaccination
The purpose of the study is to investigate and compare the cell responses to influenza vaccination in monozygotic (identical) and dizygotic (fraternal) twins to determine the roles of genetics and environment in the response to flu vaccination.
Stanford is currently accepting patients for this trial.
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
- Biological: FluMist® Quadrivalent
- Biological: Fluzone® Quadrivalent vaccine
1. Otherwise healthy, 12-49 years old, identical (MZ) or fraternal (DZ) twins.
2. Willing to complete the informed consent process (including assent for minors 12-17
years of age, inclusive).
3. Availability for follow-up for the planned duration of the study at least 28 days
4. Acceptable medical history by review of inclusion/exclusion criteria and vital signs.
1. Prior off-study vaccination with the current year's seasonal influenza vaccine.
2. Allergy to egg or egg products, or to vaccine components, (including gentamicin,
gelatin, arginine or MSG in LAIV)
3. Life-threatening reactions to previous influenza vaccinations.
4. Asthma (If yes, not eligible for Group C)).
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 first study visit and the day of
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 systemic
glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in
all groups; inhaled steroid use is not permissible).
12. In close contact with anyone who has a severely weakened immune system and requires a
protective environment (If yes, may be ineligible for Group C; exposure to such
persons should be avoided for 7 days after receipt of LAIV).
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. For children or adolescents through 17 years of age, receiving aspirin therapy or
aspirin-containing products (If yes, not eligible for Group C).
18. Receipt of blood or blood products within the past 6 months or planned used during the
19. Medical or psychiatric condition or occupational responsibilities that preclude
participant compliance with the protocol.
20. Receipt of inactivated vaccine 14 days prior to study enrollment, or planned
vaccinations prior to completion of last study visit (~ 28 days after study
21. Receipt of live, attenuated vaccine within 60 days prior to enrollment of planned
vaccination prior to completion of last study visit (~ 28 days after study
22. Need for allergy immunization (that cannot be postponed) during the study period.
23. Has taken an influenza antiviral medication within 48 hours prior to study vaccination
(If yes, not eligible for Group C).
24. History of Guillain-Barré syndrome
25. Pregnant woman
26. Lactating woman (If yes, not eligible for Group C).
27. Use of investigational agents within 30 days prior to enrollment or planned use during
28. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or
planned donation prior to completion of the last visit.
29. 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
12 Years - 49 Years
Genders Eligible for Study