Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL

Launched by ERASMUS MEDICAL CENTER · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a new type of HPV vaccine can help prevent the return of vulvar high-grade squamous intraepithelial lesions (vHSIL) in women who have already received treatment for this condition. vHSIL is a serious precancerous condition affecting the vulva, and many women face a risk of it coming back even after treatment. The goal of the trial is to see if giving the vaccine alongside standard treatments can lower the chances of recurrence and improve the overall quality of life for these women.

To participate in this trial, women must be 18 years or older, have a confirmed diagnosis of vHSIL, and be scheduled for treatment such as surgery or laser therapy. Women who have already received HPV vaccinations, have certain types of cancer, are pregnant, or have weakened immune systems are not eligible. If you join the study, you will receive either the HPV vaccine or a placebo (a harmless shot with no active ingredients) without knowing which one you got. Researchers hope that this trial will provide valuable information about preventing the recurrence of vHSIL and help improve long-term outcomes for women affected by this condition.

Gender

FEMALE

Eligibility criteria

• • 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