Safety, toxicity and immunogenicity of HPV16 E7 DNA vaccination in HPV16+ vulvar intraepithelial neoplasia grade III: a phase I study.

Completed

Conditions: VINIII
vulvar dysplasia
10038595

Registration Number: NL-OMON40423

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

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
* Written informed consent
* Histologically proven visible VINIII lesion (last histology <=3 months prior to enrolment)
* HPV16+ VINIII lesion (to be determined on archival tumour tissue (<=10 years old); if that is not available a biopsy will be required)
* No indication of an active infectious disease
* No history of autoimmune disease or systemic undercurrent disease which might affect immunocompetence
* Adequate bonemarrow, renal function and liver function

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
* Severe cardiac, respiratory or metabolic disease
* Use of steroids or other immunosuppressive drugs
* Use of oral anticoagulant drugs
* History of a malignancy except curatively treated low-stage tumour
* Severe infections requiring antibiotic
* Any treatment for the VINIII lesion within 6 weeks prior to enrolment
* Lactation or pregnancy (if applicable)
* Not willing to take adequate contraceptive measures (if applicable)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• To study the safety and toxicity of two different doses of the naked DNA<br /><br>vaccine encoding the shuffled HPV16 E7 gene products (TTFC-E7SH).<br /><br>• To study the HPV-specific immune response in two different doses of<br /><br>TTFC-E7SH.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To study the clinical response to vaccination of two different doses of<br /><br>TTFC-E7SH<br /><br><br /><br>Exploratory objectives:<br /><br>• Local immune response<br /><br>HPV16-specific proliferative capacity will be tested in triplicate in a 3 day<br /><br>proliferation assay.<br /><br>• Tumour microenvironment<br /><br>The effect of vaccination on the tumour microenvironment will be determined by<br /><br>multicolour fluorescent immunohistochemistry.</p><br>