Protective Mechanisms Against a Pandemic Respiratory Virus: B-cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 5, 2013
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Stanford University
- Enrollment
- 20
- Primary Endpoint
- Number of Participants Who Received Influenza Vaccine
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
Detailed Description
The investigators plan to study the immune response to different influenza vaccines much more broadly and deeply across different age groups and with different vaccine modalities and to probe the influence of genetics on these responses using monozygotic and dizygotic twins. The investigators plan to compare various immunological responses, identify age-specific biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of T-cell repertoire to an influenza vaccine within an individual as a function of age and to what degree this is genetically determined. The study will be conducted in healthy young identical and fraternal 1-8 year-old twins. All participants will be immunized with seasonal trivalent inactivated influenza vaccine (IIV3). Blood samples to conduct the assays described will be taken at pre-immunization, Days 6-8 and 28 post-immunization for children requiring 1 dose of vaccine. For children requiring 2 doses of vaccine, a second immunization will be given at least 28 days after Dose 1 with responses measured on Day 6-8 and Day 28-32 post-second immunization. Children 35 months and under will receive Fluzone® standard IIV3 Pediatric Dose, while children 36 months and older will receive Fluzone® standard IIV3.
Investigators
Cornelia L. Dekker
Professor, Pediatrics
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Otherwise healthy, twin children age 1-8 years (identical or fraternal twin pairs)
- •Parent willing to sign the informed consent form and child willing to sign assent if indicated.
- •Availability for follow-up for the planned duration of the study at least 28 days after last immunization.
- •Acceptable relevant medical history and vital signs.
Exclusion Criteria
- •Prior off-study vaccination with trivalent inactivated influenza vaccine (IIV3) or live attenuated influenza vaccine (LAIV) in Fall 2013
- •Allergy to egg or egg products, or to vaccine components or thimerosal (if IIV3 multidose vials used)
- •Life-threatening reactions to previous influenza vaccinations
- •Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- •History of immunodeficiency (including HIV infection)
- •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.
- •Chronic Hepatitis B or C
- •Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids are permissible). History of any cancer.
- •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.
- •History of blood dyscrasias, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
Outcomes
Primary Outcomes
Number of Participants Who Received Influenza Vaccine
Time Frame: Day 0 to 32
Secondary Outcomes
- Number of Participants With Related Adverse Events(Day 0 to 32 post-immunization)