Atopic DermatitisNCT00406081
Immune Response to Varicella Vaccination in Children With Atopic Dermatitis
An observational study of Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- Type of treatment
- Vaccines
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2005to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with or without AD who received the chicken pox vaccine including a group of AD subjects with eczema herpeticum (ADEH+)
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
National Jewish Health
Denver, Colorado, 80206
About this study
Official title: 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.
Read the 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).
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell-mediated immune responses as assessed by measurement of numbers of VZV specific T cells.
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startDec 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lynda Schneider, MD, Study chair, Boston Children's HospitalDonald Y. Leung, MD, PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406081
- Sponsor's protocol ID
- DAIT ADVN VAR 05
- Other IDs
- Contract No. HHSN266200400029C
- Status last verified
- Jan 2017
- First submitted
- 30 Nov 2006
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 20889193
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Varicella Vaccination in Subjects With Atopic Dermatitis Compared to Nonatopic Controls (VAR 05)
- ClinicalTrials.gov ID
- NCT00406081
- Acronym / sponsor ID
- DAIT ADVN VAR 05
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with or without AD who received the chicken pox vaccine including a group of AD subjects with eczema herpeticum (ADEH+)
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cell-mediated immune responses as assessed by measurement of numbers of VZV specific T cells.
Time frame: 36 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Results publication: PubMed 20889193Schneider 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.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynda Schneider, MD study chair
Boston Children's Hospital
Donald Y. Leung, MD, PhD principal investigator
National Jewish Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell-mediated immune responses as assessed by measurement of numbers of VZV specific T cells. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00406081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.