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Completed

NCT Number: NCT00407069

Role of Antimicrobial Peptides in Host Defense Against Vaccinia Virus

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for Participants With AD:

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

Role of Antimicrobial Peptides in Host Defense Against Vaccinia Virus (ADVN AMP01)

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Dec 4, 2006
Registry last updated
Oct 18, 2016

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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