Influenza Clinical Trial
Official title:
Protective Mechanisms Against a Pandemic Respiratory Virus: B-cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 5, 2013
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
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.
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