The Human Mucosal Immune Responses to Influenza Virus (SLVP026)

Not Recruiting

Trial ID: NCT03023553


This study will examine the immune responses to the seasonal influenza vaccine in single cells of the nasal passages when compared with cells in circulating blood.

Official Title

The Human Mucosal Immune Responses to Influenza Virus: A Systems Biology Approach. Innate Immune Responses to Influenza Virus in Single Human Nasal Epithelial Cells

Stanford Investigator(s)


Inclusion Criteria:

   1. Otherwise healthy, ambulatory adult between the ages of 18-30 years

   2. Willing to complete the informed consent process.

   3. Availability for follow-up at Day 2 (LAIV Group only)

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

Exclusion Criteria:

   1. Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV

   2. Allergy to egg or egg products, or to vaccine components, including thimerosal (TIV
   multidose vials only), or gentamicin, gelatin, arginine or MSG (for LAIV only).

   3. Life-threatening reactions to previous influenza vaccinations

   4. Asthma or history of wheezing (except for controls in the study who will be assigned
   to receive TIV).

   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

   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 for allergies and topical steroids are
   permissible. Inhaled steroids for conditions such as asthma are not permissible for
   volunteers in the LAIV group.

12. Participants in close contact with anyone who has a severely weakened immune system
   should not receive LAIV (LAIV Group only).

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. aspirin per day), Plavix, or Aggrenox
   must be reviewed by investigator to determine if this would affect the volunteer's

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

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

19. Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination
   prior to completion of the last study visit.

20. Live, attenuated vaccine within 60 days of vaccination or planned non-study
   vaccination prior to completion of the last study visit.

21. History of Guillain-Barré Syndrome

22. Pregnant or lactating woman

23. Use of investigational agents within 30 days prior to enrollment or planned use of
   investigational agents prior to completion of study visits.

24. 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.

25. 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.


biological: Fluzone®

biological: FluMist®

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305