NCT00406081

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2005

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

3.8 years

First QC Date

November 30, 2006

Last Update Submit

January 10, 2017

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

    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.

    36 months

Study Arms (2)

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

Eligibility Criteria

Age12 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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+)

You may qualify if:

  • Parent/guardian has signed informed consent
  • Male or female of any race or ethnicity
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related 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 Dec;126(6):1306-7.e2. doi: 10.1016/j.jaci.2010.08.010.

    PMID: 20889193RESULT

Related Links

Biospecimen

Retention: NONE RETAINED

Blood collected for endpoint measurements.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lynda Schneider, MD

    Boston Children's Hospital

    STUDY CHAIR

  • Donald Y. Leung, MD, PhD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

December 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 11, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

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.

Available IPD Datasets

Individual Participant Data Set (SDY2)Access
Study Protocol (SDY2)Access
Study design, -schedule of events, -demographics, -adverse events, -interventions, -files (SDY2)Access

Locations

US(2)