Adjuvant Gardasil 9 Vaccination for Women Treated for Vulvar HSIL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional trial compares Gardasil 9 injection versus placebo in women who have undergone treatment for vulvar HSIL. Participants are adults with histologically confirmed vHSIL planning surgery, laser, or imiquimod treatment, and have not previously received HPV vaccination. The goal is to see if adjuvant vaccination reduces recurrence and progression of disease over time. Safety and tolerability will be monitored, along with recurrence rates and HPV-related outcomes. The study is sponsored by Erasmus Medical Center with collaboration from the Dutch Cancer Society and is conducted at Erasmus MC in Rotterdam.

Why it matters

Who can join: the full rules

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

Where it's running

• Erasmus MC
  Rotterdam, Netherlands Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.