Role of Antimicrobial Peptides in Host Defense Against Vaccinia Virus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00407069|
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : October 18, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||286 participants|
|Observational Model:||Case Control|
|Official Title:||Role of Antimicrobial Peptides in Host Defense Against Vaccinia Virus (ADVN AMP01)|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
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.
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 individuals with no history of skin or respiratory disease.
- 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407069
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80207|
|Principal Investigator:||Donald Leung, MD, PhD||National Jewish Health|