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Immune Response to Varicella Vaccination in Children With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00406081
First received: November 30, 2006
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

November 30, 2006
February 5, 2013
December 2005
September 2009   (final data collection date for primary outcome measure)
Cell-mediated immune responses as assessed by measurement of numbers of VZV specific T cells. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00406081 on ClinicalTrials.gov Archive Site
To determine if children with AD have VZV-specific humoral responses to varicella vaccination that differ from those of nonatopic controls. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Immune Response to Varicella Vaccination in Children With Atopic Dermatitis
Immune Response to Varicella Vaccination in Subjects With Atopic Dermatitis Compared to Nonatopic Controls (VAR 05)

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.

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).
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   None Retained
Description:

Blood collected for endpoint measurements.
Non-Probability Sample

Children with or without AD who received the chicken pox vaccine including a group of AD subjects with eczema herpeticum (ADEH+)
Atopic Dermatitis
Not Provided
  • Participants with AD
    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
    Children without AD who received the chicken pox vaccine 2 to 16 weeks prior to the study visit
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
12 Months to 36 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00406081
DAIT ADVN VAR 05, Contract No. HHSN266200400029C
No
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Lynda Schneider, MD Children's Hospital Boston
Principal Investigator: Donald Y. Leung, MD, PhD National Jewish Health
National Institute of Allergy and Infectious Diseases (NIAID)
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP