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The Human Mucosal Immune Responses to Influenza Virus (SLVP026)
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.
The Human Mucosal Immune Responses to Influenza Virus: A Systems Biology Approach. Innate Immune Responses to Influenza Virus in Single Human Nasal Epithelial Cells
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.
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.
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