Immune Response to Varicella Vaccination in Children With Atopic Dermatitis

NCT ID: NCT00406081

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-09-30

Brief Summary

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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

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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).

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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)

No interventions assigned to this group

Nonatopic controls

Children without AD who received the chicken pox vaccine 2 to 16 weeks prior to the study visit

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynda Schneider, MD

Role: STUDY_CHAIR

Boston Children's Hospital

Donald Y. Leung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

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National Jewish Health

Denver, Colorado, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20889193 (View on PubMed)

Related Links

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https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT)

Other Identifiers

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Contract No. HHSN266200400029C

Identifier Type: -

Identifier Source: secondary_id

DAIT ADVN VAR 05

Identifier Type: -

Identifier Source: org_study_id

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