Adult female patients, with histological evidence of Vulvar intraepithelial neoplasia (VIN) grade III lesions of the squamous cell type, positive for HPV (Human Papilloma Virus)16. MedDRA version: 9.1 Level: LLT Classification code 10056574 Term: Vulval intraepithelial neoplasia
Conditions
Interventions
Product Name: HPV16 E6/E7 SLP vaccine
Product Code: ISA-HPV-01
Pharmaceutical Form: Injection*
Trade Name: Aldara
Pharmaceutical Form: Cream
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -patients of 18 years and older -willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines -histological evidence of VIN, grade III, HPV16 positive -baseline laboratory findings; white blood cells (WBC) > 3,000 x 109/l, lymphocytes > 1,000 x 109/l, platelets > 100 x 109/l, HIV- and HBV-negative -patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study -Any condition that in the opinion of the investigator could interfere with the conduct of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -known hypersensitivity to the vaccine or imiquimod or to any of the respective excipients. -indication of a current active infectious disease of the vulva or other infections that need medical attention, other than HPV16 -history of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or patients receiving immunosuppressive therapy including transplant recipients -history of a second malignancy except curatively treated low-stage tumours with a histology that can be differentiated from the vulvar/cervical cancer type -radiotherapy, chemotherapy administered within 4 weeks prior to the enrolment visit -participation in a study with another investigational drug within 30 days prior to the enrolment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To compare the immunological response to vaccination with HPV16 E6 and E7 synthetic long peptides with concomitant application of imiquimod at the vaccination site with vaccination without the concomitant application of imiquimod.;Secondary Objective: Secondary objectives: To compare the safety and clinical response to vaccination with HPV16 E6 and E7 synthetic long peptides with concomitant application of imiquimod at the vaccination site with the response to vaccination without the concomitant application of imiquimod.;Primary end point(s): The primary end point is the evaluation of the systemic immunological response. The following criteria will be used for this evaluation: - proportion of patients developing a directly ex-vivo detectable CD8+ T-cell response after 4 vaccinations | — |
Countries
Netherlands
Outcome results
None listed