Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737710
• Other study ID #: DAIT ADRN-05
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: January 19, 2016
• Start date: October 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2016
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	National Jewish Health	Denver	Colorado
United States	Oregon Health & Science University	Protland	Oregon
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Atopic Dermatitis Research Network

Country where clinical trial is conducted

United States, 

References & Publications (4)

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-? 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. — View 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. — View 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. Review. — View 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 De — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 28 post vaccination	No
Secondary	The fold difference in geometric mean titers for each influenza strain between non-atopic controls and AD participants following intradermal vaccination	Antibody levels to HA (hemagglutinin) measured in the serum. Higher antibody levels suggest better protection against the influenza virus.	Day 28 post vaccination	Yes
Secondary	The difference in proportion of participants achieving seroprotection for each influenza strain between AD participants receiving intradermal vaccination and AD participants receiving intramuscular 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.	Day 28 post vaccination	No
Secondary	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	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.	Day 28 post vaccination	No
Secondary	The difference in proportion of participants achieving seroconversion for each influenza strain between AD participants receiving intradermal vaccination and AD participants receiving intramuscular 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.	Day 28 post vaccination	Yes

External Links

•   Atopic Dermatitis Research Network (ADRN)
•   National Institute of Allergy and Infectious Diseases (NIAID)