Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Pilot
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A new flu vaccine which is injected into the skin instead of into the muscle has recently
      been approved by the Food and Drug Administration for vaccination of the general population
      including patients with atopic dermatitis (AD). This new vaccine has been shown to work as
      well as the vaccine which is injected into muscle when tested in people without atopic
      dermatitis. The primary endpoint of the study is to estimate the variance of the log fold
      change from baseline in HAI antibody titers for non-atopic controls and participants with
      atopic dermatitis without a history of eczema herpeticum (ADEH-), following administration of
      a single dose of the seasonal 2011-2012 Fluzone® Intradermal vaccine.
    

Detailed description: 
      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).
    

Intervention name(s): Fluzone® Intradermal (Sanofi Pasteur Inc.)
Intervention type(s): Drug
Intervention description(s): Fluzone® Intradermal trivalent vaccine is a clear-to-slightly opalescent, preservative-free suspension containing formaldehyde-inactivated "split" influenza viruses for intradermal delivery of 0.1 mL via an ultra-fine micro-needle. The vaccine is supplied as a single-dose, in a latex-free, pre-filled microinjection system. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs.
Fluzone® Intradermal is standardized according to United States Public Health Service (US PHS) requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2011-2012 influenza season: A/California/07/2009 X-179A (H1N1)-like virus, A/Perth/16/2009 (H3N2)-like virus, and B/Brisbane/60/2008-like virus.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science