Finding studies
Finding studies
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Lead
National Institute of Allergy and Infectious Diseases (NIAID)
With
This is a single center, open-label, mechanistic study designed to determine the variance of the antibody response in non-atopic and ADEH- participants receiving a single dose of the 2011-2012 seasonal Fluzone® Intradermal vaccine administered per label. Twenty non-atopic and 20 ADEH- (mild to severe AD) adults aged 18 to 64 years will be enrolled. Enrollment will be closely monitored to ensure that there is a similar distribution of non-atopic and ADEH- participants by gender, age, and race/ethnicity. Eligible study participants will provide a pre-vaccination blood sample (Day 0) for assessment of baseline HAI antibody titers, cellular immune response, total IgE, and allergen sensitization, and will then receive a single injection of the 2011-2012 seasonal Fluzone® Intradermal vaccine administered per label. A subset of participants will also provide blood for microarray analysis at Baseline (Day 0) and will return to the clinic 3 and 7 days post-vaccination to provide additional blood for microarray analysis. All participants will return to the study site 28 days post-vaccination for a blood draw for HAI antibody titers and cellular immune response assays. Study participants will be followed for safety, including serious adverse events (SAEs), throughout the entire duration of the study and will be asked to record solicited AEs on a diary card (Days 0-7).
Age
18–64
Sex
ALL
Healthy volunteers
Accepted
