cervical intraepithelial neoplasia lesion of the cervix
Conditions
Interventions
40 Patients will receive two sequential vaccinations containing a dose of 50ug
per peptide with a 3-week interval (week 0, 3). After 1 year patients will be
randomized to receive a booster vaccine w
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - patiënts of 18 years and older - willing and able to comply with the protocol, and provide informed consent in accordance with institutional and regulatory guidelines - histological evidence of CIN, grade I or cytological evidence of a persistent PAP II (two consecutive pap II smears with a 6 month interval) - performance status 1 or 2 at the WHO scale, or 60 on the Karnofsky scale - baseline laboratory findings; white blood cells (WBC) > 3,000 x 10 9/l, lymphocytes >1,000 x 10 9/l, platelets > 100 x 10 9/l, and hematocrit > 30%, HIV- and HBV-negative - patients of child-bearing potential should test negative using a pregnancy test and agree to utilize effective contraception or remain abstinent during the entire treatment period of the study
Exclusion criteria
Exclusion criteria: - indication of a current active infectious disease other than HPV16, - history of an autoimmune disease or other systemic intercurrent disease that might affect patient*s immunocompetence - 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 or other potentially immunosuppressive therapy administered within 4 weeks prior to the colposcopy visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| By comparing blood drawn at different time points during the study, in vitro analysis will reveal the induction of Cytotoxic T lymphocyte (CTL) immunity against HPV16E6 and E7, induction of HPV16-specific T-helper (Th) type 1 cells to evaluate the capacity of this vaccination strategy to install long term HPV-specific T cell immunity. | — |
Secondary
| Measure | Time frame |
|---|---|
| By comparing the results between the patients receiving a placebo after 1 year and patients boosted with the HPV16 peptides, the capacity of re-vaccination to boost the HPV16-specific response will be evatluated. Furthermore in vivo analysis via Skin tests will also be used to measure the presence and type of immunity against HPV16 E2, E6- and E7 peptides. | — |
Countries
Netherlands
Outcome results
None listed