Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study

This study has been completed.
Sponsor:
Collaborator:
The Atopic Dermatitis Research Network (ADRN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01737710
First received: November 27, 2012
Last updated: May 23, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:
  • Influenza Virus Trivalent Vaccine (Types A and B) (Avian)
  • Influenza Virus Vaccine, 2012-2013 Formula
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:
  • Influenza Virus Trivalent Vaccine (Types A and B) (Avian)
  • Influenza Virus Vaccine, 2012-2013 Formula
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:
  • Influenza Virus Trivalent Vaccine (Types A and B) (Avian)
  • Influenza Virus Vaccine, 2012-2013 Formula
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:
  • Influenza Virus Trivalent Vaccine (Types A and B) (Avian)
  • Influenza Virus Vaccine, 2012-2013 Formula
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:
  • Influenza Virus Trivalent Vaccine (Types A and B) (Avian)
  • Influenza Virus Vaccine, 2012-2013 Formula

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737710

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
Sponsors and Collaborators
The Atopic Dermatitis Research Network (ADRN)
Investigators
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 August 19, 2014