Cervical Intraepithelial Neoplasia cervix lesion
Conditions
Interventions
Half of the patients will be vaccinated twice with a mix of HPV E6 and E7 long
peptides at a dose of 300µg/peptide, the other half will be vaccinated with a
matching placebo.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - patients 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 II or III, HPV16 positive - 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 |
|---|---|
| Before first vaccination and 4 weeks after second vaccination (week 7), histological material will be tested for the quantity of different infiltrating immune cells. | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterisation of the HPV16-specific infiltrating T-cells; cytokine milieu and presence of HPV16. | — |
Countries
Netherlands
Outcome results
None listed