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Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age (SLVP016)

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ClinicalTrials.gov Identifier: NCT03020472
Recruitment Status : Terminated (Due to low enrollment)
First Posted : January 13, 2017
Results First Posted : March 3, 2017
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Brief Summary:
This pilot study will investigate B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples taken at designated time points before and after vaccination.

Condition or disease Intervention/treatment Phase
Influenza Biological: 2008-2009 FluMist LAIV (Intranasal) Phase 4

Detailed Description:

This is an exploratory study to determine the peripheral antibody secreting cell response during Days 5-13 after immunization with live, attenuated influenza vaccine (LAIV).

Investigators hoped to enroll 27 healthy children, 2 years of age who had not had any prior LAIV or trivalent inactivated vaccine (TIV) within the past 2 years. Due to low enrollment, the study was halted. Due to the limited number of samples, no analysis was performed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: U19 Year 6: Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age, SLVP016
Study Start Date : November 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 2008-2009 FluMist LAIV (Intranasal)
2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
Biological: 2008-2009 FluMist LAIV (Intranasal)
2008-2009 FluMist vaccine delivered intranasally




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

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

Other Outcome Measures:
  1. Post- Immunization B- Cell Response [ Time Frame: 5-13 days post immunization ]
    Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)

  2. PBMC Samples Will be Tested by Flow Cytometry to Determine the Percentage of Influenza-specific Antibody Cells That Are CD27+CD38+CD19+ Plasmablasts and by ELISPOT. [ Time Frame: Day 0 to Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Otherwise healthy children, aged 24-35 months of age, inclusive.
  2. Parent(s) or guardian(s) willing to sign informed consent.
  3. Availability for follow-up for the planned duration of the study.
  4. Acceptable medical history by screening evaluation and brief clinical assessment.
  5. Able to understand and comply with planned study procedures

Exclusion Criteria

  1. Prior vaccination with LAIV.
  2. TIV vaccination during two prior influenza vaccine seasons
  3. Known prior MD diagnosis of, or hospitalization for influenza
  4. History of asthma, active/recurrent wheezing or reactive airways disease
  5. History of immunodeficiency
  6. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
  7. Known underlying medical conditions (e.g. hemoglobinopathy, congestive heart failure) predisposing to influenza complications.
  8. Household contact with immunodeficiency due to disease, medication or radiation
  9. Child receiving aspirin therapy or aspirin-containing therapy
  10. History of Guillain-Barré syndrome
  11. Malignancy, other than squamous cell or basal cell skin cancer
  12. Autoimmune disease
  13. Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.
  14. Use of antiviral agents against Influenza A and/or B (such as Tamiflu, Relenza, Flumodine, Symmetrel) less than 48 hours before and/or less than two weeks after administration of FluMist.
  15. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow-up or hospitalization during the preceding year.
  16. Use of investigational agents within 30 days prior to study
  17. Receipt of blood products or immunoglobulin in the past 6 months
  18. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
  19. Acute febrile illness on the day of vaccination
  20. Known allergies to any component of the vaccine, including eggs or egg products, gentamicin, gelatin,or arginine, or known life-threatening reactions to previous influenza vaccinations.
  21. Concurrent participation in other investigational protocols or receipt of an investigational product within the previous 30 days or planned receipt of an investigational product within 28 days following the last immunization dose.
  22. Any condition that, in the opinion of the investigator, might interfere with study objectives

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): NCT03020472


Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Cornelia L Dekker, MD Stanford University
Principal Investigator: Harry B Greenberg, MD Stanford University
Principal Investigator: Xiaosong He, PhD Stanford University
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Responsible Party: Cornelia L. Dekker, Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT03020472    
Other Study ID Numbers: SU-15086
U19AI057229 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2017    Key Record Dates
Results First Posted: March 3, 2017
Last Update Posted: April 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cornelia L. Dekker, Stanford University:
Live, attenuated influenza vaccine
Children
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases