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Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study

This study has been completed.
Sponsor:
Collaborator:
Atopic Dermatitis Research Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01737710
First received: November 27, 2012
Last updated: February 27, 2017
Last verified: February 2017
November 27, 2012
February 27, 2017
October 2012
May 2013   (Final data collection date for primary outcome measure)
  • Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B [ Time Frame: Day 28 post vaccination ]
    The difference in the percent of participants that achieved seroprotection against influenza B at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percent of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
  • Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1 [ Time Frame: Day 28 Post Vaccination ]
    The difference in the percentage of participants that achieved seroprotection against influenza H1N1 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
  • Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2 [ Time Frame: Day 28 Post Vaccination ]
    The difference in the percentage of participants that achieved seroprotection against influenza H3N2 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
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 ]
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.
Complete list of historical versions of study NCT01737710 on ClinicalTrials.gov Archive Site
  • Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B [ Time Frame: Day 28 post vaccination ]
    The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza B between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than 1 indicated an increase in HAI antibody titers against influenza B as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza B. Participants who achieved seroprotection (which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B) prior to vaccination were excluded from the analysis.
  • Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1 [ Time Frame: Day 28 post vaccination ]
    The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H1N1 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H1N1 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1.
  • Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2 [ Time Frame: Day 28 post vaccination ]
    The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H3N2 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H3N2 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H3N2 Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2.
  • Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B [ Time Frame: Day 28 post vaccination ]
    The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza B at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
  • Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1 [ Time Frame: Day 28 Post Vaccination ]
    The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H1N1 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
  • Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2 [ Time Frame: Day 28 Post Vaccination ]
    The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H3N2 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
  • Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B [ Time Frame: Day 28 Post Vaccination ]
    The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
  • Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal - Influenza H1N1 [ Time Frame: Day 28 Post Vaccination ]
    The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
  • Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2 [ Time Frame: Day 28 Post Vaccination ]
    The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
  • Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B [ Time Frame: Day 28 Post Vaccination ]
    The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
  • Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1 [ Time Frame: Day 28 Post Vaccination ]
    The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
  • Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2 [ Time Frame: Day 28 Post Vaccination ]
    The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
  • 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 ]
    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 ]
    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 ]
    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 ]
    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.
Not Provided
Not Provided
 
Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Dermatitis, Atopic
  • 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
  • Biological: Fluzone® (Intramuscular) vaccine
    A 0.5 mL 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: 92 Non-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).
    Intervention: Biological: Fluzone® Intradermal Vaccine
  • 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).
    Intervention: Biological: Fluzone® Intradermal Vaccine
  • 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.
    Intervention: Biological: Fluzone® (Intramuscular) vaccine
  • 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.
    Intervention: Biological: Fluzone® (Intramuscular) vaccine
  • 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).
    Intervention: Biological: Fluzone® Intradermal Vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
368
May 2013
May 2013   (Final data collection date for primary outcome measure)

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; and
  • 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 ineligible based on the opinion of the Investigator.
Sexes Eligible for Study: Female
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01737710
DAIT ADRN-05
No
Not Provided
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Atopic Dermatitis Research Network
Study Chair: Donald Leung, MD, PhD National Jewish Health
National Institute of Allergy and Infectious Diseases (NIAID)
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP