Status:
COMPLETED
Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Pilot
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Atopic Dermatitis Research Network
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-64 years
Phase:
EARLY_PHASE1
Brief 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...
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 seasona...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01518478
Start Date
November 1 2011
End Date
March 1 2012
Last Update
March 1 2017
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206