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Can an HPV shot stop vulvar lesions from coming back?

NCT ID NCT06052696

Prevention Sponsor: Erasmus Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Women treated for vulvar high-grade squamous intraepithelial lesion (vHSIL), a precancerous condition linked to HPV, often see it return. This trial tests whether giving the Gardasil 9 HPV vaccine alongside standard treatment (surgery, laser, or imiquimod) can lower that recurrence risk. Half of the 500 participants receive the vaccine and half receive a placebo, and researchers compare how many in each group have the lesion return at 6 and 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gardasil 9, a vaccine that protects against nine types of human papillomavirus
What this could lead to
If it works, the vaccine could become a routine add-on after treatment for vulvar HSIL, lowering the chance the lesions return and sparing women repeated surgery.
What could go wrong
The trial may find the vaccine does not reduce recurrences, or the benefit may be smaller than earlier non-randomised studies suggested. Vaccination can cause soreness, swelling, or fever, and it does not treat existing HPV infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

human papilloma virus infection vulvar intraepithelial neoplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HPV Vulvar hsil

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erasmus MC

    RECRUITING

    Rotterdam, Netherlands

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