ADRN Influenza Vaccine Pilot

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).

Inclusion Criteria:

Participants who meet all of the following criteria are eligible for enrollment.

- Who are males and females 18 to 64 years of age, inclusive, on the day of
vaccination.

- Who are enrolled in the ADRN Registry study.

- Who have active, mild to severe AD without a history of EH or who are non-atopic as
diagnosed using the ADRN Standard Diagnostic Criteria. Non-atopic status will be
based on self-reported history and will not take total IgE or allergen sensitization
results into account.

- Who are willing to sign the informed consent form prior to initiation of any study
procedure.

Exclusion Criteria:

Participants who meet any of the following criteria are not eligible for enrollment.

- Who are pregnant or lactating. Women of child bearing potential must avoid becoming
pregnant (use of an effective method of contraception or abstinence) for the duration
of their participation in the study.

- Who have a known allergy to any component of the Fluzone® Intradermal vaccine,
including egg protein, or have had a severe allergic reaction to a previous dose of
any influenza vaccine.

- Who have a known or suspected congenital or acquired immunodeficiency or who have had
immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy
within the preceding 6 months.

- Who have received systemic steroid therapy at any dose or intra-articular
administration of steroids within 3 months prior to the day of vaccination.

- Who have received a cumulative dose of inhaled and/or intranasally administered
corticosteroids ≥ 880 mcg/day fluticasone equivalent within 3 months prior to the day
of vaccination.

- Who have a chronic illness, including but not limited to, cardiac, renal, or
auto-immune disorders, or diabetes, at a stage that could interfere with study
conduct or completion, based on the opinion of the Investigator.

- Who have a neoplastic disease or any hematologic malignancy, (excluding uncomplicated
non-melanoma skin cancer and participants who have a history of neoplastic disease
and have been disease free for at least five years).

- Who have participated in another clinical trial investigating a vaccine, drug,
medical device, or a medical procedure in the four weeks preceding the study
vaccination or who plan to participate in another clinical trial during the present
study period.

- Who have any skin disease other than AD that might compromise the stratum corneum
barrier (e.g., bullous disease, psoriasis, cutaneous T cell lymphoma [also called
Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or
Darier's disease).

- Who have received blood or blood-derived products that might interfere with the
assessment of immune response in the past 3 months prior to vaccination or who plan
to receive such products during the study period.

- Who have received previous vaccination (Fluzone® or another vaccine) against
influenza in the past 6 months prior to vaccination.

- Who have received any other vaccinations in the 4 weeks preceding study vaccination
or who plan to receive any vaccination in the 4 weeks following study vaccination.

- Who have had thrombocytopenia or bleeding disorder in the 3 weeks preceding
vaccination.

- Who have had a personal or family history of Guillain-Barré Syndrome.

- Who have a first degree relative already enrolled in the study.

- Who are determined to be not eligible based on the opinion of the Investigator.

- Who require Class I or II topical corticosteroids or calcineurin inhibitors for
long-term control of their eczema.

Temporary Vaccination Exclusion Criteria:

Should one of the conditions listed below occur, the Investigator will postpone
vaccination until the condition is resolved.

- Signs and symptoms of an acute infectious respiratory illness.

- Febrile illness (temperature ≥ 37.5°C [or ≥ 99.5°F]) or moderate or severe acute
illness/infection on the day of vaccination.

- Atopic dermatitis flare, a worsening of the AD participant's skin condition,
requiring increased level of baseline treatment during the previous 7 days.
Participant must not have applied Class I or II topical corticosteroids or
calcineurin inhibitors to any part of the body in the 7 days prior to vaccination.
Non-class I or II topical corticosteroids must not have been applied to the deltoid
region of the extremity to be vaccinated in the 7 days prior to vaccination.

- Who have taken antipyretics and/or analgesics (e.g. acetaminophen, ibuprofen) within
24 hours prior to the time of vaccination.