The long-term immune response after HPV16 peptide vaccination in woman with low-grade pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

Phase 2

Completed

Conditions: cervical intraepithelial neoplasia
lesion of the cervix
10013364

Registration Number: NL-OMON31739

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>By comparing blood drawn at different time points during the study, in vitro<br /><br>analysis will reveal the induction of Cytotoxic T lymphocyte (CTL) immunity<br /><br>against HPV16E6 and E7, induction of HPV16-specific T-helper (Th) type 1 cells<br /><br>to evaluate the capacity of this vaccination strategy to install long term<br /><br>HPV-specific T cell immunity. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>By comparing the results between the patients receiving a placebo after 1 year<br /><br>and patients boosted with the HPV16 peptides, the capacity of re-vaccination to<br /><br>boost the HPV16-specific response will be evatluated.<br /><br>Furthermore in vivo analysis via Skin tests will also be used to measure the<br /><br>presence and type of immunity against HPV16 E2, E6- and E7 peptides.</p><br>