This clinical trial is focused on studying a condition called Vulvar High-Grade Squamous Intraepithelial Lesion (vHSIL). This is a skin condition affecting the vulva, which is the outer part of the female genitalia. The study is testing a treatment using a vaccine called Gardasil 9, which is a type of Human Papillomavirus (HPV) vaccine. This vaccine is designed to protect against nine different types of HPV, which are viruses that can cause skin and mucous membrane growths, such as warts, and are linked to certain cancers.
The purpose of the study is to see if the HPV vaccine can help prevent the recurrence of vHSIL after women have been treated for it. Participants in the study will receive either the Gardasil 9 vaccine or a placebo, which is a substance with no active ingredients. The study will follow participants for up to 24 months to monitor for any recurrence of the condition. The vaccine is given as an injection into the muscle, and the study will involve several visits over the course of the trial period.
Throughout the study, researchers will compare the number of women who experience a return of vHSIL between those who receive the HPV vaccine and those who receive the placebo. They will also look at how the vaccine affects different types of HPV and whether it impacts the quality of life, sexual health, and productivity of the participants. The study aims to provide valuable information on the effectiveness of the HPV vaccine in preventing the recurrence of this condition and potentially improving the overall health outcomes for women affected by vHSIL.



The Netherlands