Trial Search Results

Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers (SLVP032)

The investigators collected blood and lymphoid tissues routinely discarded during surgery from adults after a routine seasonal influenza vaccination to determine how immune memory develops at the actual site of infection, and how immunization may alter this process.

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: Fluzone®
  • Biological: FluMist®

Phase:

Phase 4

Eligibility


Inclusion Criteria:

   1. Generally healthy 18-49 year old male and female patients undergoing tonsillectomy for
   obstructive sleep apnea.

   2. Willing to complete the informed consent process

   3. Availability for follow-up for the planned duration of the study

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

Exclusion Criteria:

   1. Prior off-study vaccination with seasonal influenza vaccine within three months of
   study vaccination

   2. Life-threatening reactions to previous influenza vaccinations

   3. Asthma (contraindication for receipt of LAIV4) for study volunteers; not a
   contraindication for enrolling as a pilot phase volunteer receiving IIV4.

   4. Allergy to egg or egg products or to vaccine components (including gentamicin,
   gelatin, arginine or MSG for participants receiving LAIV4).

   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; may include significant liver
   disease, diabetes mellitus treated with insulin or moderate to severe renal disease

   8. Hospitalization in the past year for congestive heart failure or emphysema.

   9. Chronic Hepatitis B or C.

10. Recent or current use of immunosuppressive medication, including systemic
   glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible).
   Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review
   by the investigator.

11. Participants who care for severely immunosuppressed persons that require a protective
   environment should not receive LAIV, or should avoid contact with such persons for 7
   days after receipt, given the theoretical risk for transmission of the live attenuated
   vaccine virus to close contacts. [If yes, may be ineligible]

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 protocol.

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 up to 325 mg. per day), Plavix, or Aggrenox will be
   reviewed by investigators to determine if study participation would affect the
   volunteer's safety or compliance with the protocol.

16. Has taken an influenza antiviral medication within 48 hours prior to study vaccination
   [For volunteers receiving LAIV; If yes, may not eligible if unable to schedule at an
   appropriate interval].

17. Receipt of blood or blood products within the past 6 months or planned use during the
   study.

18. Medical or psychiatric condition or occupational responsibilities that preclude
   participant compliance with the protocol

19. Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned
   vaccinations prior to completion of last study visit (~ 14 days after study
   vaccination)

20. Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned
   vaccination prior to completion of last study visit (~ 14 days after study enrollment)

21. Need for allergy immunization (that cannot be postponed) until after the last study
   visit.

22. History of Guillain-Barré syndrome

23. Pregnant woman;

24. Breastfeeding woman [if volunteer will receive LAIV4]

25. Use of investigational agents within 30 days prior to enrollment or planned use during
   the study.

26. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or
   donation of platelets within 2 weeks of enrollment or planned donation prior to
   completion of the last visit.

27. 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 - 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
Not Recruiting