Atopic DermatitisNCT00407069
Role of Antimicrobial Peptides in Host Defense Against Vaccinia Virus
An observational study of Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. Recent studies have demonstrated that the skin of people with AD my have decreased antimicrobial peptide (AMP) expression. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Feb 2010
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People of good general health
Who may be able to join
- 2 years of age or older
- History of active or inactive AD OR eczema herpeticum, as defined by the ADVN standardized diagnostic criteria
- Parent or guardian willing to provide informed consent, if applicable
- Male or female of any race and ethnicity
- Inclusion Criteria for Participants With Asthma or Psoriasis, and for non-atopic controls:
- 18 years or older
Show all 9Show fewer
- History of psoriasis OR history of asthma not requiring systemic medications
- Parent or guardian willing to provide informed consent, if applicable
- Male or female of any race and ethnicity
Who cannot join
- Oral corticosteroids or any systemic immunosuppressive or immunomodulatory medication within 28 days prior to study entry
- Immunotherapy within 3 months prior to study entry
- History of bleeding disorder
- Aspirin, oral antihistamines, oral antibiotics, oral cyclosporine, or topical medications within 7 days of screening visit including, but not restricted to, Protopic, Elidel, topical corticosteroids, and topical antibiotics
- Anxiolytic agents and antidepressants within 2 days of screening visit
- Diabetic requiring medication
Show all 14Show fewer
- Autoimmune or immunodeficiency
- Active fungal, bacterial, or viral infections within 7 days prior to study entry
- Active systemic cancer. Participants with uncomplicated nonmelanoma skin cancer are not excluded.
- Theophylline or leukotriene antagonists within 24 hours of screening visit
- Received any vaccination within 30 days prior to study entry
- Known lidocaine allergy
- Previously vaccinated for smallpox
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Antimicrobial Peptides in Host Defense Against Vaccinia Virus (ADVN AMP01)
Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. Recent studies have demonstrated that the skin of people with AD my have decreased antimicrobial peptide (AMP) expression. The purpose of this study is to compare smallpox virus replication and the number of AMPs and other antiviral molecules in people with AD, as compared to those seen in people with psoriasis or asthma, or healthy individuals.
Read the detailed description
AD is a chronic inflammatory skin disease characterized by frequent viral skin infections. Recent studies have found that components in the skin of people with AD may block AMP expression. AMPs are responsible for preventing infection from viruses. The purpose of this study is to examine smallpox virus replication and AMP expression in the skin of patients with AD as well as identify other antiviral molecules involved in immune response. These findings will be compared with those of people with psoriasis or asthma, or healthy individuals. This study will consist of one study visit at which skin and blood samples will be taken.
- 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 |
|---|---|---|
| Active Atopic Dermatitis (AD) | Pediatric and adult subjects who fulfill the criteria for AD, a chronic inflammatory skin disease. | |
| Inactive Atopic Dermatitis (AD) | Adult subjects with a prior history of active AD that has been quiescent for at least 1 year. | |
| Psoriatics | Adult subjects who fulfill the criteria for plaque psoriasis, a chronic inflammatory skin disease. | |
| Asthmatics (without a history of AD) | Adult subjects who fulfill the criteria for asthma (reactive airway disease) and have a negative history of skin disease. | |
| Eczema Herpeticum (EH | Pediatric and adult AD subjects with a history of EH. | |
| Healthy Volunteers | Healthy individuals with no history of skin or respiratory disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of vaccinia virus mRNA in non-lesional skin following inoculation with untreated vaccinia virus will be evaluated using real-time RT-PCR (Reverse transcription polymerase chain reaction).
Measured: 5 years
Secondary outcomes (5)
Expression of cytokines, AMPs, other antiviral molecules, or epidermal differentiation proteins in non-lesional skin prior to and after inoculation with vaccinia virus will be evaluated using real-time RT-PCR.
Measured: 5 years
Keratinocytes will be stimulated with vaccinia virus in the presence and absence of Th1 or Th2 cytokines. Non-lesional AD skin will be stimulated with vaccinia virus in the presence of antibodies that neutralize Th2 cytokines.
Measured: 5 years
Vaccinia virus replication will be evaluated using a standard viral plaque assay in BS-C-1 cells and by analyzing vaccinia virus mRNA expression using real-time RT-PCR in keratinocytes and BS-C-1 cells.
Measured: 5 years
Expression of over 20,000 genes will be evaluated by GeneChip microarrays in non-lesional skin, and PBMCs stimulated with vaccinia virus. Real-time RT-PCR of skin and PBMC will be used to confirm gene alterations found in GeneChip microarrays.
Measured: 5 years
Ability of structural analogues of CSAs (Cyclosporine) to kill purified vaccinia virus as well as keratinocytes infected with vaccinia virus in vitro.
Measured: 5 years
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 startJun 2005
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Prospective
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Donald Leung, MD, PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407069
- Sponsor's protocol ID
- DAIT ADVN AMP 01
- Status last verified
- Oct 2016
- First submitted
- 30 Nov 2006
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Howell MD, Jones JF, Kisich KO, Streib JE, Gallo RL, Leung DY. Selective killing of vaccinia virus by LL-37: implications for eczema vaccinatum. J Immunol. 2004 Feb 1;172(3):1763-7. doi: 10.4049/jimmunol.172.3.1763.
PubMed 14734759Nomura I, Goleva E, Howell MD, Hamid QA, Ong PY, Hall CF, Darst MA, Gao B, Boguniewicz M, Travers JB, Leung DY. Cytokine milieu of atopic dermatitis, as compared to psoriasis, skin prevents induction of innate immune response genes. J Immunol. 2003 Sep 15;171(6):3262-9. doi: 10.4049/jimmunol.171.6.3262.
PubMed 12960356Howell MD, Wollenberg A, Gallo RL, Flaig M, Streib JE, Wong C, Pavicic T, Boguniewicz M, Leung DY. Cathelicidin deficiency predisposes to eczema herpeticum. J Allergy Clin Immunol. 2006 Apr;117(4):836-41. doi: 10.1016/j.jaci.2005.12.1345. Epub 2006 Feb 14.
PubMed 16630942Leung DY, Boguniewicz M, Howell MD, Nomura I, Hamid QA. New insights into atopic dermatitis. J Clin Invest. 2004 Mar;113(5):651-7. doi: 10.1172/JCI21060.
PubMed 14991059Howell MD, Gallo RL, Boguniewicz M, Jones JF, Wong C, Streib JE, Leung DY. Cytokine milieu of atopic dermatitis skin subverts the innate immune response to vaccinia virus. Immunity. 2006 Mar;24(3):341-8. doi: 10.1016/j.immuni.2006.02.006.
PubMed 16546102Howell MD, Gao P, Kim BE, Lesley LJ, Streib JE, Taylor PA, Zaccaro DJ, Boguniewicz M, Beck LA, Hanifin JM, Schneider LC, Hata TR, Gallo RL, Kaplan MH, Barnes KC, Leung DY. The signal transducer and activator of transcription 6 gene (STAT6) increases the propensity of patients with atopic dermatitis toward disseminated viral skin infections. J Allergy Clin Immunol. 2011 Nov;128(5):1006-14. doi: 10.1016/j.jaci.2011.06.003. Epub 2011 Jul 18.
PubMed 21762972Grigoryev DN, Howell MD, Watkins TN, Chen YC, Cheadle C, Boguniewicz M, Barnes KC, Leung DY. Vaccinia virus-specific molecular signature in atopic dermatitis skin. J Allergy Clin Immunol. 2010 Jan;125(1):153-159.e28. doi: 10.1016/j.jaci.2009.10.024.
PubMed 20109744
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Antimicrobial Peptides in Host Defense Against Vaccinia Virus (ADVN AMP01)
- ClinicalTrials.gov ID
- NCT00407069
- Acronym / sponsor ID
- DAIT ADVN AMP 01
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (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) is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. Recent studies have demonstrated that the skin of people with AD my have decreased antimicrobial peptide (AMP) expression. The purpose of this study is to compare smallpox virus replication and the number of AMPs and other antiviral molecules in people with AD, as compared to those seen in people with psoriasis or asthma, or healthy individuals.
Detailed description
AD is a chronic inflammatory skin disease characterized by frequent viral skin infections. Recent studies have found that components in the skin of people with AD may block AMP expression. AMPs are responsible for preventing infection from viruses. The purpose of this study is to examine smallpox virus replication and AMP expression in the skin of patients with AD as well as identify other antiviral molecules involved in immune response. These findings will be compared with those of people with psoriasis or asthma, or healthy individuals. This study will consist of one study visit at which skin and blood samples will be taken.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Active Atopic Dermatitis (AD) | – | –Pediatric and adult subjects who fulfill the criteria for AD, a chronic inflammatory skin disease. |
| Inactive Atopic Dermatitis (AD) | – | –Adult subjects with a prior history of active AD that has been quiescent for at least 1 year. |
| Psoriatics | – | –Adult subjects who fulfill the criteria for plaque psoriasis, a chronic inflammatory skin disease. |
| Asthmatics (without a history of AD) | – | –Adult subjects who fulfill the criteria for asthma (reactive airway disease) and have a negative history of skin disease. |
| Eczema Herpeticum (EH | – | –Pediatric and adult AD subjects with a history of EH. |
| Healthy Volunteers | – | –Healthy individuals with no history of skin or respiratory disease. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People of good general health
Key inclusion criteria (9 listed)
- 2 years of age or older
- History of active or inactive AD OR eczema herpeticum, as defined by the ADVN standardized diagnostic criteria
- Parent or guardian willing to provide informed consent, if applicable
- Male or female of any race and ethnicity
- Inclusion Criteria for Participants With Asthma or Psoriasis, and for non-atopic controls:
Key exclusion criteria (14 listed)
- Oral corticosteroids or any systemic immunosuppressive or immunomodulatory medication within 28 days prior to study entry
- Immunotherapy within 3 months prior to study entry
- History of bleeding disorder
- Aspirin, oral antihistamines, oral antibiotics, oral cyclosporine, or topical medications within 7 days of screening visit including, but not restricted to, Protopic, Elidel, topical corticosteroids, and topical antibiotics
- Anxiolytic agents and antidepressants within 2 days of screening visit
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
Expression of vaccinia virus mRNA in non-lesional skin following inoculation with untreated vaccinia virus will be evaluated using real-time RT-PCR (Reverse transcription polymerase chain reaction).
Time frame: 5 years
5 secondary outcomes
Expression of cytokines, AMPs, other antiviral molecules, or epidermal differentiation proteins in non-lesional skin prior to and after inoculation with vaccinia virus will be evaluated using real-time RT-PCR.
Time frame: 5 years
Keratinocytes will be stimulated with vaccinia virus in the presence and absence of Th1 or Th2 cytokines. Non-lesional AD skin will be stimulated with vaccinia virus in the presence of antibodies that neutralize Th2 cytokines.
Time frame: 5 years
Vaccinia virus replication will be evaluated using a standard viral plaque assay in BS-C-1 cells and by analyzing vaccinia virus mRNA expression using real-time RT-PCR in keratinocytes and BS-C-1 cells.
Time frame: 5 years
Expression of over 20,000 genes will be evaluated by GeneChip microarrays in non-lesional skin, and PBMCs stimulated with vaccinia virus. Real-time RT-PCR of skin and PBMC will be used to confirm gene alterations found in GeneChip microarrays.
Time frame: 5 years
Ability of structural analogues of CSAs (Cyclosporine) to kill purified vaccinia virus as well as keratinocytes infected with vaccinia virus in vitro.
Time frame: 5 years
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 18 Oct 2016.
- Background: PubMed 14734759Howell MD, Jones JF, Kisich KO, Streib JE, Gallo RL, Leung DY. Selective killing of vaccinia virus by LL-37: implications for eczema vaccinatum. J Immunol. 2004 Feb 1;172(3):1763-7. doi: 10.4049/jimmunol.172.3.1763.
- Background: PubMed 12960356Nomura I, Goleva E, Howell MD, Hamid QA, Ong PY, Hall CF, Darst MA, Gao B, Boguniewicz M, Travers JB, Leung DY. Cytokine milieu of atopic dermatitis, as compared to psoriasis, skin prevents induction of innate immune response genes. J Immunol. 2003 Sep 15;171(6):3262-9. doi: 10.4049/jimmunol.171.6.3262.
- Background: PubMed 16630942Howell MD, Wollenberg A, Gallo RL, Flaig M, Streib JE, Wong C, Pavicic T, Boguniewicz M, Leung DY. Cathelicidin deficiency predisposes to eczema herpeticum. J Allergy Clin Immunol. 2006 Apr;117(4):836-41. doi: 10.1016/j.jaci.2005.12.1345. Epub 2006 Feb 14.
- Background: PubMed 14991059Leung DY, Boguniewicz M, Howell MD, Nomura I, Hamid QA. New insights into atopic dermatitis. J Clin Invest. 2004 Mar;113(5):651-7. doi: 10.1172/JCI21060.
- Results publication: PubMed 16546102Howell MD, Gallo RL, Boguniewicz M, Jones JF, Wong C, Streib JE, Leung DY. Cytokine milieu of atopic dermatitis skin subverts the innate immune response to vaccinia virus. Immunity. 2006 Mar;24(3):341-8. doi: 10.1016/j.immuni.2006.02.006.
- Results publication: PubMed 21762972Howell MD, Gao P, Kim BE, Lesley LJ, Streib JE, Taylor PA, Zaccaro DJ, Boguniewicz M, Beck LA, Hanifin JM, Schneider LC, Hata TR, Gallo RL, Kaplan MH, Barnes KC, Leung DY. The signal transducer and activator of transcription 6 gene (STAT6) increases the propensity of patients with atopic dermatitis toward disseminated viral skin infections. J Allergy Clin Immunol. 2011 Nov;128(5):1006-14. doi: 10.1016/j.jaci.2011.06.003. Epub 2011 Jul 18.
- Results publication: PubMed 20109744Grigoryev DN, Howell MD, Watkins TN, Chen YC, Cheadle C, Boguniewicz M, Barnes KC, Leung DY. Vaccinia virus-specific molecular signature in atopic dermatitis skin. J Allergy Clin Immunol. 2010 Jan;125(1):153-159.e28. doi: 10.1016/j.jaci.2009.10.024.
- 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.
Donald Leung, MD, PhD principal investigator
National Jewish Health
1 site 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 1 site 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 9 inclusion and 14 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 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Expression of vaccinia virus mRNA in non-lesional skin following inoculation with untreated vaccinia virus will be evaluated using real-time RT-PCR (Reverse transcription polymerase chain reaction). (time frame: 5 years). 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 NCT00407069, which also lists 7 linked publications.
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 18 Oct 2016.