This is a prospective pilot study designed to suggest differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will be collected at standard time points. The duration of the study for each participant will be approximately 1 month.
This is a prospective pilot study in 20 males and non-pregnant females, 20 to 30 years old, inclusive, who are in good health and meet all eligibility criteria. The study is designed to evaluate differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly. Participants will be sorted to either Arm A (Naïve) or Arm B (Experienced) based on their vaccination history. Those vaccinated no more than 2 out of the past 5 years will be in Arm A. Those vaccinated 3 or more out of the past 5 years will be in Arm B. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. The duration of the study for each participant will be approximately 1 month. Subjects will return for clinic visits on Days 3, 8, 15, and 29 during the month follow-up period following vaccination. The study has two primary objectives; to evaluate the antibody response to the influenza vaccine in people who are vaccinated regularly and those vaccinated less regularly; the second is to evaluate circulating follicular helper T cells (TFH) in people who are vaccinated regularly and those vaccinated less regularly.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
The Hope Clinic of the Emory Vaccine Center
Atlanta, Georgia, United States
Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer
Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.
Time frame: Baseline (Day 1), Day 29
Change in Mean Level of Circulating Follicular Helper T (TFH) Cells
TFH cells will be collected via blood draw. Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.
Time frame: Up to 15 Days
Change in Mean Levels of Plasmablasts
Plasmablasts will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Time frame: Up to 29 Days
Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29
Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Time frame: Baseline (Day 1) and Day 29
Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells
Antigen-specific Interleukin 2 (IL-2) producing cluster of differentiation 4 (CD4)+ T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Time frame: Up to 29 Days
Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells
CD8+T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
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Time frame: Up to 29 Days