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OpenTrials
Completed

NCT Number: NCT00406081

Immune Response to Varicella Vaccination in Children With Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health, Denver, Colorado, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cell-mediated immune responses as assessed by measurement of numbers of VZV specific T cells.

    Time frame: 36 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 4, 2006
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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