Trial Search Results

Genetic and Environmental Factors in the Response to Influenza Vaccination

The purpose of the study is to investigate and compare the immune 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 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: FluMist® Quadrivalent
  • Biological: Fluzone® Quadrivalent vaccine

Phase:

Phase 4

Eligibility


Inclusion Criteria

   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
   after immunization.

   4. Acceptable medical history by review of inclusion/exclusion criteria and vital signs.

Exclusion Criteria

   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
   vaccination.

   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
   vaccination.

   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
   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. 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
   study.

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
   vaccination).

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
   vaccination).

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
   the study.

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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cornelia L Dekker, MD
650-724-4437
Recruiting