Immune Response to Varicella Vaccination in Children With Atopic Dermatitis

Study Overview
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Brief Summary
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Atopic dermatitis (AD) causes people to be susceptible to skin infection and inflammations. The purpose of this study is to determine the immune response to chicken pox vaccine in children with or without AD who received the vaccine 2 to 16 weeks prior to the study visit.

Detailed Description
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AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. Children with AD given the smallpox vaccine could develop a life-threatening condition known as eczema vaccinatum. This immune response is not currently understood. The purpose of this study is to understand the immune response to a viral vaccine in children with AD. This will be accomplished by studying immune response to the chicken pox vaccine in children with AD in comparison to those without AD. This study will consist of one study visit occurring about 2 to 16 weeks after the child received the chicken pox vaccination. During this visit, physical and skin exams will occur. Personal and family medical histories and blood collection will also occur. The chicken pox vaccine will not be given as a part of this study. Subjects will receive the results of radioallergosorbent (RAST) testing that will tell if they are allergic to some common items (e.g., mold, grass).

Official Title
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Immune Response to Varicella Vaccination in Subjects With Atopic Dermatitis Compared to Nonatopic Controls (VAR 05)

Conditions
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Atopic Dermatitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent/guardian has signed informed consent Male or female of any race or ethnicity 12 to 36 months of age, inclusive Healthy subjects with no systemic disorders and subjects with moderate to severe AD including a group of subjects with ADEH+ Previously vaccinated for varicella by a physician 3 weeks prior to the Study Visit (subjects receiving the vaccine 2-16 weeks prior will also be accepted) Exclusion Criteria: History of infection with chicken pox Oral, intravenous, or intramuscular corticosteroids within 30 days prior to chicken pox immunization Asthmatics receiving more than 500 micrograms per day of inhaled budesonide or more than 220 micrograms per day of inhaled fluticasone Antiherpes antiviral agents within 7 days prior to immunization Suspected immune deficiency or family history of primary immunodeficiency History of or active cancer Active untreated tuberculosis (TB) Respiratory illness at the time of chicken pox vaccination Receipt of blood products or chicken pox zoster immune globulin within the last 5 months prior to study entry

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with AD<br>Children with AD who received the chicken pox vaccine 2 to 16 weeks prior to the study visit (including a group of AD subjects with eczema herpeticum) | |
| Nonatopic controls<br>Children without AD who received the chicken pox vaccine 2 to 16 weeks prior to the study visit | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell-mediated immune responses as assessed by measurement of numbers of VZV specific T cells. |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if children with AD have VZV-specific humoral responses to varicella vaccination that differ from those of nonatopic controls. |  | 36 months |