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N/A N=368 Randomized Prevention

Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study

Dermatitis, Atopic

Enrolled (actual)
368
Serious AEs
0.5%
Results posted
Jan 2017
Primary outcome: Primary: Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B — 34.4; 22.5 percentage of participants — p=0.082

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Fluzone® Intradermal Vaccine (Biological); Fluzone® (Intramuscular) vaccine (Biological)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
May 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
34.4; 22.5 0.082
PRIMARY
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1
84.1; 86.4 0.801
PRIMARY
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
84.7; 73.3 0.177
SECONDARY
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
2.6; 2.0 0.092
SECONDARY
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
22.4; 37.7 0.103
SECONDARY
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
10.1; 9.7 0.895
SECONDARY
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B
34.4; 33.7 >0.999
SECONDARY
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1
84.1; 92.5 0.253
SECONDARY
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2
84.7; 93.9 0.218
SECONDARY
Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
40.6; 30.4 0.140
SECONDARY
Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal - Influenza H1N1
85.7; 88.1 0.791
SECONDARY
Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
76.3; 73.3 0.833
SECONDARY
Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B
40.6; 47.8 0.378
SECONDARY
Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1
85.7; 88.7 0.783
SECONDARY
Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2
76.3; 87.8 0.143

Summary

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.

Eligibility 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; 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01737710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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