HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN - ADSORBED for Vulvar high-grade squamous intraepithelial lesion (vHSIL)

Inclusion criteria

• {"criterion_text":"- Women 18 years or older"}
• {"criterion_text":"- Vulvar High-grade Squamous Intraepithelial Lesion (HSIL), histologically proven"}
• {"criterion_text":"- Planned for treatment (surgical, laser or imiquimod) for vulvar High Grade Squamous Intraepithelial Lesion"}

Exclusion criteria

• {"criterion_text":"- Prior HPV vaccination"}
• {"criterion_text":"- (Micro-) invasive carcinoma or history of HPV related genital carcinoma (cervix, anal, vulva)"}
• {"criterion_text":"- Pregnancy"}
• {"criterion_text":"- Women allergic to vaccine components"}
• {"criterion_text":"- HIV infection"}
• {"criterion_text":"- Immune compromised patients (currently on immunosuppressive medication)"}

Primary endpoints

• {"endpoint_text":"- Difference in number and percentage of patients with clinical recurrence rate of vulvar HSIL between HPV vaccination and placebo up to 24 months post-treatment.","definition_or_measurement_approach":"Clinical recurrence rate of vulvar HSIL measured as number and percentage of patients with recurrence up to 24 months post-treatment; comparison between HPV vaccination and placebo."}

Secondary endpoints

• {"endpoint_text":"- Difference in number and percentage of patients with clinical recurrence rate of vulvar HSIL between HPV vaccination and placebo at 6 and 12 months.","definition_or_measurement_approach":"Clinical recurrence rate measured at 6 and 12 months; number and percentage compared between vaccination and placebo."}
• {"endpoint_text":"- Difference in number and percentage of patients with clinical recurrence rate of vulvar HSIL between HPV vaccination and placebo at 6 and 12 months for primary vHSIL versus recurrent vHSIL.","definition_or_measurement_approach":"Subgroup analysis by primary versus recurrent vHSIL at 6 and 12 months; number and percentage compared between groups."}
• {"endpoint_text":"- Difference in number and percentage of patients with clinical recurrence rate of vulvar HSIL between the different treatment modalities.","definition_or_measurement_approach":"Comparison of recurrence rates (number and percentage) across different treatment modalities (laser, imiquimod, excision) between vaccination and placebo."}
• {"endpoint_text":"- Difference in number and percentage for additional treatment necessary after primary treatment.","definition_or_measurement_approach":"Number and percentage of patients requiring additional treatment after primary treatment compared between groups."}
• {"endpoint_text":"- Description and percentage of different HPV types. Percentage clearance of primary HPV type for vaccination versus placebo.","definition_or_measurement_approach":"HPV typing and clearance rates of primary HPV type expressed as percentages compared between vaccination and placebo."}
• {"endpoint_text":"- Number of HPV antibodies and percentage of increase or decrease after vaccination. Is there correlation between number or percentage of recurrence. Is that different in primary versus recurrent episode vHSIL.","definition_or_measurement_approach":"Serological measurement of HPV antibody counts and percent change after vaccination; correlation analysis with recurrence rates and comparison between primary and recurrent episodes."}
• {"endpoint_text":"- Incremental cost-effectiveness ratio (ICER), described the difference in costs and budget impact analysis.","definition_or_measurement_approach":"Health economic evaluation using ICER, cost and budget impact analyses (using iMCQ and iPCQ questionnaires)."}
• {"endpoint_text":"- Description and change in numeric value and percentage in different score form questionnaires. Percentage increase of decrease quality of life, sexual impact and productivity impact.","definition_or_measurement_approach":"Questionnaire-based assessment (EuroQol 5D-5L, FSFI, productivity measures) with numeric change and percent change compared between groups."}
• {"endpoint_text":"- Difference number and percentage in HPV types cervical cytology and vHSIL before and after vaccination.","definition_or_measurement_approach":"Comparison of HPV types and cervical cytology results (number and percentage) before and after vaccination between groups."}
• {"endpoint_text":"- Difference in number and percentage in recurrence rate of vulvar HSIL and vulvar cancer between HPV vaccination and placebo. Other HPV related disease known?","definition_or_measurement_approach":"Long-term comparison of recurrence rates of vHSIL and vulvar cancer (number and percentage) between vaccination and placebo; assessment of other HPV-related diseases."}

Netherlands

Earliest CTIS Part Ii Submission Date

20-12-2023

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

812

Number Of Sites

41

Number Of Participants

498

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"KWF (Dutch Cancer Society)","duties_or_roles":"Source of monetary support","organisation_type":""}