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The Human Mucosal Immune Responses to Influenza Virus (SLVP026)

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ClinicalTrials.gov Identifier: NCT03023553
Recruitment Status : Completed
First Posted : January 18, 2017
Results First Posted : March 9, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluzone® Biological: FluMist® Phase 4

Detailed Description:

Using state-of-the-art technology, the investigators hope the information learned from this study will help identify and describe important factors in the early-stage development of influenza immunity and possibly lead to the development of more effective vaccines. This study will be conducted in healthy male and female volunteers 18-30 years of age who received one of two seasonal influenza vaccine types, intramuscular standard trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV) given by intranasal spray.

Participants are divided into two groups. The control group will receive the 2012-2013 formulation of the standard intramuscular trivalent inactivated influenza vaccine (TIV). A blood sample and nasopharyngeal swab samples (one from each nostril) will be collected at a single visit, Day 0. For those in the live, attenuated influenza vaccine (LAIV) group, at the first visit, they will receive a single administration of the 2012-2013 formulation of LAIV. At the second study visit two days later, they will provide a blood sample and two nasopharyngeal swab samples (one from each nostril).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : December 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
TIV Group
Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Biological: Fluzone®
Influenza Virus Vaccine Suspension for Intramuscular Injection

LAIV Group
Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
Biological: FluMist®
Influenza Virus Vaccine Live, Intranasal Spray




Primary Outcome Measures :
  1. Number of Participants From Each Arm Who Received Influenza Vaccine [ Time Frame: Day 0 to 28 ]

Secondary Outcome Measures :
  1. Number of Participants With Related Adverse Events [ Time Frame: Day 0 to 28 post-immunization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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
  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 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. aspirin per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety..
  17. Receipt of blood or blood products within the past 6 months of planned used during the study.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023553


Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Cornelia Dekker, MD Stanford University
Principal Investigator: Harry Greenberg, MD Stanford University
Principal Investigator: Xiaosong He, PhD Stanford Universityh

Responsible Party: Cornelia L. Dekker, Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT03023553     History of Changes
Other Study ID Numbers: SU-25537
U19AI090019 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2017    Key Record Dates
Results First Posted: March 9, 2017
Last Update Posted: April 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique identification code and the volunteer identity (except for age) will not be disclosed.

Keywords provided by Cornelia L. Dekker, Stanford University:
Trivalent, inactivated influenza vaccine
Live, attenuated influenza vaccine
Nasopharyngeal swabs
Young adults

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs