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Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL

RecruitingPhase 4Ages 18 Years - 100 YearsFemaleErasmus Medical Center
NCT06052696 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Problem description: Yearly, approximately 45000 women develop vulvar cancer worldwide. It is estimated that about 30% of all vulvar carcinomas are HPV related. As with other HPV related (pre)malignancies, the incidence has been rising over the past 20 years. The peak incidence of premalignant lesions of the vulva, also called Vulvar High Grade Squamous Intraepithelial Lesion (vHSIL), lies between 35 and 40 years of age. Multiple treatments are available, including surgery, laser vaporization, and topical imiquimod, with comparable success rate. Despite treatment, at least 30% of women will develop a recurrence within 2 years, with a much higher lifetime risk of recurrence. This results in multiple treatments with sometimes disfiguring effects and associated negative psychosocial and psychosexual impact. Woman with vulvar HSIL have a lifelong increased risk of vulvar cancer, and approxi

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📋 Eligibility rules (as published)
Inclusion criteria * Women 18 years or older * Vulvar High-grade Squamous Intraepithelial Lesion (vHSIL), histologically proven * Planned for treatment (surgical, laser or imiquimod) for vHSIL 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
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What it tests

  • Gardasil 9 Suspension for Injection
  • Placebo
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Where

1 site
Erasmus MC
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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