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

Status Completed

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.

Clinical Trial Description

n/a

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

• NCT number: NCT01737710
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Completion date: May 2013