Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection (SLVP031)

Not Recruiting

Trial ID: NCT03028987


The purpose of this study is provide a better understanding of the adaptive immune response to the licensed flu vaccines. The investigators hope the information learned from this study will help identify and describe important factors of influenza immunity especially of or specific proteins associated with the T-cell immune response.

Official Title

Project 1. The Role of CD4+ Memory Phenotype, Memory, and Effector T-Cells in Vaccination and Infection - Influenza-specific DR1501+ and DR0701+ T-cells


Inclusion Criteria:

   1. Otherwise healthy 18-49 years old identical (MZ) twins identified as DR1501+ or
   DR0701+ by lab assay results. Both twins in the pair must be willing to participate in
   the study.

   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 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

   3. Life-threatening reactions to previous influenza vaccinations

   4. Asthma (a contraindication for receipt of LAIV4)

   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. 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]

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

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 an 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 a 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. History of Guillain-Barré syndrome

24. Pregnant or lactating woman

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
   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.


biological: Fluzone®

biological: FluMist®

Not Recruiting

Contact Information

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