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Study on HPV Vaccine for Women with Vulvar HSIL: Evaluating the Effectiveness of Nonavalent HPV Vaccine in Preventing Recurrence of Vulvar High-Grade Lesions

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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 research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the criteria: being a woman aged 18 or older, having a confirmed diagnosis of vulvar high-grade squamous intraepithelial lesion (vHSIL), and planning for treatment such as surgery, laser, or imiquimod.

  2. Step 2

    Initial treatment

    Undergo the planned treatment for vHSIL. This could involve surgical procedures, laser treatment, or the application of imiquimod, a topical medication.

  3. Step 3

    Vaccination or placebo administration

    Receive an injection of either the Gardasil 9 vaccine or a placebo. The vaccine is a suspension for injection designed to protect against nine types of human papillomavirus (HPV).

    The administration is done through an intramuscular injection, which means the injection is given directly into a muscle.

  4. Step 4

    Follow-up assessments

    Attend regular follow-up visits to monitor for any recurrence of vHSIL. These assessments occur at 6, 12, and 24 months after the initial treatment.

    The primary goal is to evaluate the difference in recurrence rates between those who received the vaccine and those who received the placebo.

  5. Step 5

    Additional evaluations

    Participate in additional evaluations to assess the presence of different HPV types, the necessity for further treatment, and the impact on quality of life.

    These evaluations also include measuring the number of HPV antibodies and analyzing any changes in cervical cytology and vHSIL.

  6. Step 6

    Study completion

    The study is expected to conclude by January 1, 2029. Final assessments will be conducted to determine the overall effectiveness of the vaccine in preventing the recurrence of vHSIL.

Who can join the trial?

3 criteria

  • Women who are **18 years or older**
  • Have a **Vulvar High-grade Squamous Intraepithelial Lesion (HSIL)**, which means there are abnormal cells on the surface of the vulva, confirmed by a medical test
  • Are **planned for treatment** for the vulvar HSIL, which can include surgery, laser treatment, or a cream called imiquimod

Who cannot join the trial?

4 criteria

  • Patients who are not women cannot participate in the study.
  • Patients who are not diagnosed with a Vulvar High-Grade Squamous Intraepithelial Lesion (vHSIL) cannot participate. This is a specific condition affecting the vulva, which is part of the female reproductive system.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who belong to a vulnerable population, which means groups that might need special protection or care, are not included in this study.
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Investigated drugs

Nonavalent HPV Vaccine This vaccine is designed to protect against nine different types of the human papillomavirus (HPV). In this study, it is used as an additional treatment for women who have been treated for high-grade squamous intraepithelial lesions (HSIL) of the vulva. The goal is to see if the vaccine can help prevent the recurrence of these lesions over a period of 24 months.

What is already known about the treatment

Nonavalent HPV Vaccine – This vaccine is administered through an injection, typically into the muscle of the upper arm. It is currently being studied in clinical trials to assess its effectiveness in preventing the recurrence of vulvar high-grade squamous intraepithelial lesions (vHSIL) in women. The vaccine is designed to protect against nine types of human papillomavirus (HPV), which are known to cause various cancers and genital warts. It works by stimulating the immune system to recognize and fight these HPV types, thereby reducing the risk of developing related lesions. The nonavalent HPV vaccine is classified as a prophylactic vaccine, aimed at preventing disease rather than treating it.

Investigated diseases

Vulvar High-Grade Squamous Intraepithelial Lesion (vHSIL) – This condition involves abnormal changes in the skin cells of the vulva, which are considered precancerous. It is characterized by the presence of high-grade lesions that can be detected through a biopsy. These lesions are often associated with infection by certain types of human papillomavirus (HPV). Over time, if left untreated, these lesions may progress to vulvar cancer. The condition can cause symptoms such as itching, burning, or pain in the vulvar area, although some individuals may not experience any symptoms. Monitoring and management are important to prevent progression to more severe conditions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506792-94-00Estimated enrolment498 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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