Influenza Clinical Trial
Official title:
Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization
The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in healthy young adults. In particular, we will use unique strategies to study in detail the immune responses of immunoglobulins and antibody CDR3 before and after immunization.
This is an exploratory study using a strategy that has not been previously employed to
investigate B-cell responses. We will collect blood samples from the volunteers at a higher
frequency than in the two previous flu seasons to better define the dynamic response to
vaccination. The objective is to compare the Ig gene repertoire before and after vaccination
by deep sequencing PBMC and proteomic analysis of antibody CDR3 regions at 10 different time
points before and after immunization.
This is a Phase IV study of healthy adults who are given standard TIV off-season. There are
no exclusions for gender, ethnicity or race. Following confirmation of written informed
consent, baseline blood samples will be drawn from all study participants at Day -5, Day -3
and Day 0 prior to immunization, and at Days 1, 4, 7, 9, 11, 28 and 180 post-immunization.
Volunteers will be vaccine-naïve for the 2010-2011 and 2011-2012 seasonal influenza
vaccines. All participants will receive a single dose of the current seasonal influenza
vaccine by intramuscular (IM) injection at Day 0.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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