Immune Response to Varicella Vaccination in Children With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406081
• Other study ID #: DAIT ADVN VAR 05
• Secondary ID: Contract No. HHS
• Status: Completed
• Phase: N/A
• First received: November 30, 2006
• Last updated: January 10, 2017
• Start date: December 2005
• Est. completion date: September 2009

Study information

• Verified date: January 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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	Cell-mediated immune responses as assessed by measurement of numbers of VZV specific T cells.		36 months	No
Secondary	To determine if children with AD have VZV-specific humoral responses to varicella vaccination that differ from those of nonatopic controls.		36 months	No

External Links

•   Division of Allergy, Immunology, and Transplantation (DAIT)
•   National Institute of Allergy and Infectious Diseases (NIAID)