Clinical trial NCT00406081: Immune Response to Varicella Vaccination in Children With Atopic Dermatitis
Official title: Immune Response to Varicella Vaccination in Subjects With Atopic Dermatitis Compared to Nonatopic Controls (VAR 05)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2006-12-04
Enrollment: 69
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with or without AD who received the chicken pox vaccine including a group of AD subjects with eczema herpeticum (ADEH+)

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Cell-mediated immune responses as assessed by measurement of numbers of VZV specific T cells.
timeFrame: 36 months
Secondary outcomes:
measure: To determine if children with AD have VZV-specific humoral responses to varicella vaccination that differ from those of nonatopic controls.
timeFrame: 36 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Lynda Schneider, MD
role: STUDY_CHAIR
affiliation: National Jewish Health
name: Donald Y. Leung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 Dec;126(6):1306-7.e2. doi: 10.1016/j.jaci.2010.08.010.