NCT01737710

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-11-29
• Last updated: 2017-03-29
• Results posted: 2017-01-06

Locations

5 sites across 1 country: United States