Clinical trial NCT01737710: Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study
Official title: A Randomized Open Label Mechanistic Study in Atopic Dermatitis to Assess the Immunogenicity of Fluzone® Intradermal and Intramuscular Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: Influenza Vaccines
Dermatitis
Injections, Intradermal
Injections, Intramuscular
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Atopic Dermatitis Research Network
First posted: 2012-11-29
Enrollment: 368
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
timeFrame: Day 28 post vaccination
measure: Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1
timeFrame: Day 28 Post Vaccination
measure: Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
timeFrame: Day 28 Post Vaccination
Secondary outcomes:
measure: 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
timeFrame: Day 28 post vaccination
measure: 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
timeFrame: Day 28 post vaccination
measure: 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
timeFrame: Day 28 post vaccination
measure: Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B
timeFrame: Day 28 post vaccination
measure: Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1
timeFrame: Day 28 Post Vaccination
measure: Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2
timeFrame: Day 28 Post Vaccination
measure: Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
timeFrame: Day 28 Post Vaccination
measure: Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal - Influenza H1N1
timeFrame: Day 28 Post Vaccination
measure: Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
timeFrame: Day 28 Post Vaccination
measure: Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B
timeFrame: Day 28 Post Vaccination
measure: Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1
timeFrame: Day 28 Post Vaccination
measure: Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2
timeFrame: Day 28 Post Vaccination
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Protland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: National Jewish Health
name: Donald Leung, MD, PhD
role: STUDY_CHAIR
References:
citation: Leung DY, Gao PS, Grigoryev DN, Rafaels NM, Streib JE, Howell MD, Taylor PA, Boguniewicz M, Canniff J, Armstrong B, Zaccaro DJ, Schneider LC, Hata TR, Hanifin JM, Beck LA, Weinberg A, Barnes KC. Human atopic dermatitis complicated by eczema herpeticum is associated with abnormalities in IFN-gamma response. J Allergy Clin Immunol. 2011 Apr;127(4):965-73.e1-5. doi: 10.1016/j.jaci.2011.02.010.
citation: Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009 Oct 17;374(9698):1339-50. doi: 10.1016/S0140-6736(09)61208-3.
citation: Pulendran B, Li S, Nakaya HI. Systems vaccinology. Immunity. 2010 Oct 29;33(4):516-29. doi: 10.1016/j.immuni.2010.10.006.
citation: Schneider L, Weinberg A, Boguniewicz M, Taylor P, Oettgen H, Heughan L, Zaccaro D, Armstrong B, Holliday A, Leung DY. Immune response to varicella vaccine in children with atopic dermatitis compared with nonatopic controls. J Allergy Clin Immunol. 2010 Dec;126(6):1306-7.e2. doi: 10.1016/j.jaci.2010.08.010.
citation: Leung DYM, Jepson B, Beck LA, Hanifin JM, Schneider LC, Paller AS, Monti K, David G, Canniff J, Lorenzo MG, Weinberg A. A clinical trial of intradermal and intramuscular seasonal influenza vaccination in patients with atopic dermatitis. J Allergy Clin Immunol. 2017 May;139(5):1575-1582.e8. doi: 10.1016/j.jaci.2016.12.952. Epub 2017 Feb 13.
citation: Jalbert E, Lussier S, Johnson MJ, Jepson B, Calatroni A, David G, Leung D, Weinberg A. Lower influenza-specific cell-mediated immune responses in individuals with atopic dermatitis compared with healthy controls. Hum Vaccin Immunother. 2020 Nov 1;16(11):2727-2735. doi: 10.1080/21645515.2020.1747374. Epub 2020 Apr 29.