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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: January 10, 2017
Last verified: January 2017
  Purpose
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.

Condition
Atopic Dermatitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Immune Response to Varicella Vaccination in Subjects With Atopic Dermatitis Compared to Nonatopic Controls (VAR 05)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Cell-mediated immune responses as assessed by measurement of numbers of VZV specific T cells. [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained
Blood collected for endpoint measurements.

Enrollment: 69
Study Start Date: December 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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+)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406081

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Lynda Schneider, MD Boston Children’s Hospital
Principal Investigator: Donald Y. Leung, MD, PhD National Jewish Health
  More Information

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY2
ImmPort study identifier is SDY2.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SDY2
ImmPort study identifier is SDY2.

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00406081     History of Changes
Other Study ID Numbers: DAIT ADVN VAR 05
Contract No. HHSN266200400029C
Study First Received: November 30, 2006
Last Updated: January 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Chickenpox
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 23, 2017