Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study
Status: | Completed |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 64 |
Updated: | 4/21/2016 |
Start Date: | October 2012 |
End Date: | May 2013 |
A Randomized Open Label Mechanistic Study in Atopic Dermatitis to Assess the Immunogenicity of Fluzone® Intradermal and Intramuscular Vaccines
Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with
severe itching. People who have atopic dermatitis often have complications from skin
infections; these can include eczema herpeticum after herpes simplex virus infection or
eczema vaccinatum after smallpox vaccination. People with atopic dermatitis may suffer from
skin infections and may therefore respond differently to vaccinations.
A new flu vaccine which is injected into the skin instead of into muscle has recently been
approved by the Food and Drug Administration for vaccination of the general population
including patients with atopic dermatitis. 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 main purpose of this study is to compare how people with atopic dermatitis
respond to this new flu vaccine compared to non-atopic volunteers without atopic dermatitis.
The second purpose is to look at how people with atopic dermatitis respond to the new
vaccine which is injected into the skin compared to the vaccine which is injected into
muscle.
severe itching. People who have atopic dermatitis often have complications from skin
infections; these can include eczema herpeticum after herpes simplex virus infection or
eczema vaccinatum after smallpox vaccination. People with atopic dermatitis may suffer from
skin infections and may therefore respond differently to vaccinations.
A new flu vaccine which is injected into the skin instead of into muscle has recently been
approved by the Food and Drug Administration for vaccination of the general population
including patients with atopic dermatitis. 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 main purpose of this study is to compare how people with atopic dermatitis
respond to this new flu vaccine compared to non-atopic volunteers without atopic dermatitis.
The second purpose is to look at how people with atopic dermatitis respond to the new
vaccine which is injected into the skin compared to the vaccine which is injected into
muscle.
Inclusion Criteria:
- enrolled in the ADRN Registry study.
- active, mild to severe AD (lesions present) with or without a history of eczema
herpeticum or who are non-atopic as diagnosed using the ADRN Standard Diagnostic
Criteria.
- willing to sign the informed consent form prior to initiation of any study procedure.
Exclusion Criteria:
- 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.
- have a known allergy to any component of the Fluzone® Intradermal or Fluzone®
(Intramuscular) vaccines, including egg protein, or have had a severe allergic
reaction to a previous dose of any influenza vaccine.
- known or suspected congenital or acquired immunodeficiency or who have had
immunosuppressive therapy (excluding steroids) such as anti-cancer chemotherapy or
radiation therapy within the preceding 6 months.
- received systemic steroid therapy for 2 or more weeks at a dose ≥ 20 mg/day
prednisone equivalent within 1 month prior to the day of vaccination or expect to
receive within 3 weeks post-vaccination.
- received a cumulative dose of inhaled and/or intranasally administered
corticosteroids ≥ 880 mcg/day fluticasone equivalent for 2 or more weeks within 1
month prior to the day of vaccination or expect to receive within 3 weeks
post-vaccination.
- 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. Asthma and underlying allergic
conditions such as allergic rhinitis are not exclusionary.
- a neoplastic disease or any hematologic malignancy. Participants who have been
disease free for at least six months will not be excluded.
- 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.
- 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).
- 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.
- received previous vaccination (Fluzone® or another vaccine) against influenza in the
past 6 months prior to vaccination.
- received any other live vaccines within 4 weeks or inactivated vaccines within 2
weeks prior to study vaccination or who plan to receive any vaccination during the
study period.
- thrombocytopenia or bleeding disorder in the 3 weeks preceding vaccination.
- personal or family history of Guillain-Barré Syndrome.
- a first degree relative already enrolled in the study.
- determined to be not eligible based on the opinion of the Investigator.
We found this trial at
5
sites
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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