Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dermatitis, Atopic |
Biological: Fluzone® Intradermal Vaccine Biological: Fluzone® (Intramuscular) vaccine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized Open Label Mechanistic Study in Atopic Dermatitis to Assess the Immunogenicity of Fluzone® Intradermal and Intramuscular Vaccines |
- The difference in proportion of participants achieving seroprotection for each influenza strain between non-atopic controls and moderate to severe atopic dermatitis AD participants following intradermal vaccination [ Time Frame: Day 28 post vaccination ] [ Designated as safety issue: No ]Seroprotection is defined as a post-vaccination serum HAI (hemagglutinin inhibition) antibody titer of 1:40 or greater. Fisher exact test will be used to examine the difference in rates of seroprotection between different groups of vaccine participants.
- The fold difference in geometric mean titers for each influenza strain between non-atopic controls and AD participants following intradermal vaccination [ Time Frame: Day 28 post vaccination ] [ Designated as safety issue: Yes ]Antibody levels to HA (hemagglutinin) measured in the serum. Higher antibody levels suggest better protection against the influenza virus.
- The difference in proportion of participants achieving seroprotection for each influenza strain between AD participants receiving intradermal vaccination and AD participants receiving intramuscular vaccination [ Time Frame: Day 28 post vaccination ] [ Designated as safety issue: No ]Seroprotection is defined as a post-vaccination serum HAI (hemagglutinin inhibition) antibody titer of 1:40 or greater. Fisher exact test will be used to examine the difference in rates of seroprotection between different groups of vaccine participants.
- The difference in proportion of participants achieving seroconversion for each influenza strain between non-atopic controls and moderate to severe AD participants receiving intradermal vaccination [ Time Frame: Day 28 post vaccination ] [ Designated as safety issue: No ]Seroconversion is defined as a 4-fold increase from baseline HAI (hemagglutinin inhibition) antibody titer. Fisher exact test will be used to examine the difference in rates of Seroconversion between different groups of vaccine participants.
- The difference in proportion of participants achieving seroconversion for each influenza strain between AD participants receiving intradermal vaccination and AD participants receiving intramuscular vaccination [ Time Frame: Day 28 post vaccination ] [ Designated as safety issue: Yes ]Seroconversion is defined as a 4-fold increase from baseline HAI (hemagglutinin inhibition) antibody titer. Fisher exact test will be used to examine the difference in rates of Seroconversion between different groups of vaccine participants.
| Estimated Enrollment: | 316 |
| Study Start Date: | October 2012 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 92 Nnon-atopic controls vaccinated with Fluzone® Intradermal
Non-atopic controls who will receive a single dose of the seasonal 2012-2013 Fluzone® Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
|
Biological: Fluzone® Intradermal Vaccine
A 0.1mL single-dose, in a latex-free, pre-filled microinjection system with an ultra-fine micro-needle. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® Intradermal is approved for use in persons 18 through 64 years of age and will be purchased from Sanofi Pasteur, Inc.
Other Names:
|
|
Experimental: Moderate to severe AD vaccinated with Fluzone® Intradermal
92 moderate to severe atopic dermatitis participants who will receive a single dose of the seasonal 2012-2013 Fluzone® Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
|
Biological: Fluzone® Intradermal Vaccine
A 0.1mL single-dose, in a latex-free, pre-filled microinjection system with an ultra-fine micro-needle. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® Intradermal is approved for use in persons 18 through 64 years of age and will be purchased from Sanofi Pasteur, Inc.
Other Names:
|
|
Active Comparator: Moderate to severe AD vaccinated with Fluzone® (Intramuscular)
92 moderate to severe atopic dermatitis participants who will receive a single dose of the seasonal 2012-2013 Fluzone® (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
|
Biological: Fluzone® (Intramuscular) vaccine
A 0.5mL single-dose delivered via syringe using single-dose vials. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® for intramuscular injection is approved for persons 6 months and older and will be purchased from Sanofi Pasteur, Inc.
Other Names:
|
|
Active Comparator: Non-atopic controls vaccinated with Fluzone® (Intramuscular)
20 non-atopic controls who will receive a single dose of the seasonal 2012-2013 Fluzone® (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
|
Biological: Fluzone® (Intramuscular) vaccine
A 0.5mL single-dose delivered via syringe using single-dose vials. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® for intramuscular injection is approved for persons 6 months and older and will be purchased from Sanofi Pasteur, Inc.
Other Names:
|
|
Experimental: Mild AD participants vaccinated with Fluzone® Intradermal
20 mild atopic dermatitis participants who will receive a single dose of the seasonal 2012-2013 Fluzone® Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
|
Biological: Fluzone® Intradermal Vaccine
A 0.1mL single-dose, in a latex-free, pre-filled microinjection system with an ultra-fine micro-needle. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® Intradermal is approved for use in persons 18 through 64 years of age and will be purchased from Sanofi Pasteur, Inc.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Colorado | |
| National Jewish Health | |
| Denver, Colorado, United States, 80206 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Massachusetts | |
| Boston Children's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Protland, Oregon, United States, 97239 | |
| Study Chair: | Donald Leung, MD, PhD | National Jewish Health |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT01737710 History of Changes |
| Other Study ID Numbers: | DAIT ADRN-05 |
| Study First Received: | November 27, 2012 |
| Last Updated: | May 23, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Influenza Vaccines Dermatitis Injections, Intradermal Injections, Intramuscular Skin Diseases Skin Diseases, Eczematous |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Genetic Diseases, Inborn Skin Diseases, Genetic |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013