Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study

Condition(s) targeted: Dermatitis, Atopic

Intervention: Fluzone® Intradermal Vaccine (Biological); Fluzone® (Intramuscular) vaccine (Biological)

Phase: N/A

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Donald Leung, MD, PhD, Study Chair, Affiliation: National Jewish Health

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.

Official title: A Randomized Open Label Mechanistic Study in Atopic Dermatitis to Assess the Immunogenicity of Fluzone® Intradermal and Intramuscular Vaccines

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: 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

Secondary outcome:

The fold difference in geometric mean titers for each influenza strain between non-atopic controls and AD participants following intradermal vaccination

The difference in proportion of participants achieving seroprotection for each influenza strain between AD participants receiving intradermal vaccination and AD participants receiving intramuscular vaccination

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

The difference in proportion of participants achieving seroconversion for each influenza strain between AD participants receiving intradermal vaccination and AD participants receiving intramuscular vaccination

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Female.

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.

National Jewish Health, Denver, Colorado 80206, United States

Northwestern University, Chicago, Illinois 60611, United States

Boston Children's Hospital, Boston, Massachusetts 02115, United States

University of Rochester Medical Center, Rochester, New York 14642, United States

Oregon Health & Science University, Protland, Oregon 97239, United States

Atopic Dermatitis Research Network (ADRN)

National Institute of Allergy and Infectious Diseases (NIAID)

Related publications:

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-γ response. J Allergy Clin Immunol. 2011 Apr;127(4):965-73.e1-5. doi: 10.1016/j.jaci.2011.02.010. Erratum in: J Allergy Clin Immunol. 2011 Oct;128(4):833.

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.

Pulendran B, Li S, Nakaya HI. Systems vaccinology. Immunity. 2010 Oct 29;33(4):516-29. doi: 10.1016/j.immuni.2010.10.006. Review.

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.

Starting date: October 2012
Last updated: May 23, 2013