The effect of HPV16 peptide vaccination on the local immune response in woman with high grade HPV16+ pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

Phase 2

Completed

• Conditions: Cervical Intraepithelial Neoplasia; cervix lesion; 10013364

• Registration Number: NL-OMON31758
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 34

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

- 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>Before first vaccination and 4 weeks after second vaccination (week 7),<br /><br>histological material will be tested for the quantity of different infiltrating<br /><br>immune cells.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Characterisation of the HPV16-specific infiltrating T-cells; cytokine milieu<br /><br>and presence of HPV16.</p><br>