VINIII vulvar dysplasia
Conditions
Interventions
TTFC-E7SH will be injected intradermally on days 0, 3 and 6 using a permanent
make-up device, and boost vaccinations will be given after 4 weeks (day 28, 31
and 34).
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To study the safety and toxicity of two different doses of the naked DNA vaccine encoding the shuffled HPV16 E7 gene products (TTFC-E7SH). • To study the HPV-specific immune response in two different doses of TTFC-E7SH. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To study the clinical response to vaccination of two different doses of TTFC-E7SH Exploratory objectives: • Local immune response HPV16-specific proliferative capacity will be tested in triplicate in a 3 day proliferation assay. • Tumour microenvironment The effect of vaccination on the tumour microenvironment will be determined by multicolour fluorescent immunohistochemistry. | — |
Countries
Netherlands
Outcome results
None listed