Influenza
Conditions
Keywords
Live, attenuated influenza vaccine, Children
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.
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.
Interventions
BIOLOGICAL2008-2009 FluMist LAIV (Intranasal)
2008-2009 FluMist vaccine delivered intranasally
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Months to 35 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Received Influenza Vaccine | Day 0 to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Related Adverse Events | Day 0 to Day 28 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post- Immunization B- Cell Response | 5-13 days post immunization | Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV) |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2008-2009 FluMist LAIV (Intranasal) 2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | 2008-2009 FluMist LAIV (Intranasal) |
|---|---|
| Age, Continuous | 2.4 years STANDARD_DEVIATION 0.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Number of Participants Who Received Influenza Vaccine
Time frame: Day 0 to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2008-2009 FluMist LAIV (Intranasal) | Number of Participants Who Received Influenza Vaccine | 6 Participants |
Secondary
Number of Participants With Related Adverse Events
Time frame: Day 0 to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2008-2009 FluMist LAIV (Intranasal) | Number of Participants With Related Adverse Events | 0 Participants |
Other Pre-specified
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
Other Pre-specified
Post- Immunization B- Cell Response
Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)
Time frame: 5-13 days post immunization
Population: Due to the low enrollment, the study was terminated and analysis was not performed.