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

U19 Year 6: Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age, SLVP016

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.

Study Overview

• Status: Terminated
• Conditions: Influenza
• Intervention / Treatment: Biological: 2008-2009 FluMist LAIV (Intranasal)

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Who Received Influenza Vaccine	Day 0 to Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Related Adverse Events	Day 0 to Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post- Immunization B- Cell Response	Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)	5-13 days post immunization
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.		Day 0 to Day 28

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Children; Live, attenuated influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: SU-15086; U19AI057229 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No