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

Influenza Clinical Trial

— SLVP016  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03020472
• Other study ID #: SU-15086
• Secondary ID: U19AI057229
• Status: Terminated
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: January 2009

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 35 Months

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• 2008-2009 FluMist LAIV (Intranasal)
2008-2009 FluMist vaccine delivered intranasally

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Number of Participants Who Received Influenza Vaccine		Day 0 to Day 28
Secondary	Number of Participants With Related Adverse Events		Day 0 to Day 28