Testing the safety and immune response of HPV-DNA vaccination in patients with a HPV-positive preinvasive lesion of the vulva.
Completed
- Conditions
- VIN III lesion, immunotherapy, HPVVIN III laesie, immuuntherapie, HPV
- Registration Number
- NL-OMON27857
- Lead Sponsor
- KI-AV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
* Age above 18 years
* Willing and able to undergo the planned study procedures
Exclusion Criteria
* Prior treatment with anti-HPV agents
* Participation in a study with another investigational drug within 30 days prior to the enrolment in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method * To study the safety and toxicity of two different doses of the naked DNA vaccine encoding the shuffled HPV16 E7 gene products (TTFC-E7SH).<br /><br>* To study the HPV-specific immune response in two different doses of TTFC-E7SH.
- Secondary Outcome Measures
Name Time Method * To study the clinical response to vaccination of two different doses of TTFC-E7SH<br><br /><br /><br>Exploratory outcomes:<br /><br>* Local immune response<br /><br>HPV16-specific proliferative capacity will be tested in triplicate in a 3 day proliferation assay.<br /><br>* Tumour microenvironment<br /><br>The effect of vaccination on the tumour microenvironment will be determined by multicolour fluorescent immunohistochemistry.