MedPath

VulVaccin study

Phase 1
Conditions
Vulvar High-Grade Squamous Intraepithelial Lesion (vHSIL)
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Registration Number
CTIS2023-506792-94-00
Lead Sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
498
Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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