AuthorisedTherapeutic confirmatory (Phase III)Interventional

Multicenter, randomized, double-blinded, placebo-controlled phase 3 trial to evaluate nonavalent HPV vaccine as a secondary prevention in patients treated for human papilloma virus related high-grade squamous intraepithelial lesions.(BioHPV)

This research trial is testing if a vaccine called Gardasil 9 can help prevent abnormal cell changes caused by the Human Papillomavirus (HPV) from returning. These cell changes are known as high-grade squamous intraepithelial lesions (HSIL), and they can affect areas like the cervix, vulva, penis, or anus. Participants in the study have already received treatment for these abnormal cells. Some will get the Gardasil 9 vaccine, while others will receive a dummy vaccine (placebo). Doctors will carefully check if the vaccine helps stop the abnormal cells from coming back and will also monitor for any side effects. The study aims to find a new way to prevent these cell changes from returning after they've been treated. It's for adults aged 18 and over, of any gender.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Institut Gustave Roussy

Enrolment target

984

Start

28 Jan 2026

Patients with primary HPV high-grade squamous intra-epithelial lesions (HSIL) at any site (vulvar VIN vaginal VaIN penile (PeIN)cervical CIN anal AIN) at the time of treatment.

What is this study about?

This study is a research trial looking into how we can better prevent certain types of abnormal cell changes from coming back after they've been treated. These cell changes are caused by a common virus called Human Papillomavirus (HPV) and are sometimes called 'high-grade squamous intraepithelial lesions' or HSIL. These lesions can appear in various parts of the body, such as the cervix, vulva, penis, vagina, or anus. If left untreated, some of these abnormal cells could potentially develop into cancer.

The main goal of this study is to see if a special HPV vaccine, called Gardasil 9, can help stop these abnormal cells from returning once they've been successfully treated. We know that Gardasil 9 protects against certain types of HPV infections that cause these cell changes in the first place, but we want to see if it can also help prevent them from coming back in people who have already had them and received treatment.

Participants in this study will have already had treatment for these abnormal HPV-related cell changes. They will then either receive the Gardasil 9 vaccine or a dummy vaccine (placebo). The research team will then carefully follow everyone to see if the abnormal cells return and how quickly, as well as checking for any side effects from the vaccine. This research could help us find a new way to provide long-lasting protection for people who have been affected by these HPV-related cell changes.

Key takeaways

This study evaluates if the Gardasil 9 vaccine can prevent abnormal HPV-related cells from returning after treatment.
It's for people aged 18 and over who have already had high-grade cell changes (HSIL) in areas like the cervix or anus.
Participants will receive either the Gardasil 9 vaccine or a dummy vaccine.
The study involves regular check-ups and follow-up for several years.
It aims to find new ways to offer long-term protection against these abnormal cells.
Your decision to participate is entirely voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old, and there's no upper age limit. The study is open to both men and women.

The most important thing is that you've recently been treated for high-grade abnormal cell changes caused by HPV. These abnormal cells might have been found on your cervix, vulva, penis, vagina, or anus. The study is specifically for people who have had these types of pre-cancerous lesions.

The research team will check all your medical records to make sure you fit all the necessary criteria to ensure the study is safe and effective for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently had treatment for high-grade abnormal cell changes caused by HPV?
Were these abnormal cells found on your cervix, vulva, penis, vagina, or anus?
Are you able to attend regular follow-up appointments for several years?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive several doses of either the Gardasil 9 vaccine or a dummy vaccine (placebo) as an injection. This will happen over a set period, likely a few months. You won't know whether you're receiving the actual vaccine or the placebo, and neither will the study doctors – this is a common way to make sure the results are fair.

Throughout the study, you'll have regular check-ups and follow-up appointments. These visits will involve doctors monitoring your health and checking for any return of the abnormal cells. You may also be asked to provide samples for HPV testing and to answer questions about your health and sexual well-being at different times during the study. This follow-up will continue for several years to see the long-term effects, typically for 2 to 5 years. The exact number of visits and tests will be explained in detail if you consider joining.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you might receive the Gardasil 9 vaccine, which could help prevent the abnormal cell changes from returning. However, there's also a chance you could receive the placebo (dummy vaccine) and not get the direct protective effect of Gardasil 9. Like all vaccines, Gardasil 9 can have side effects, which are usually mild, such as soreness, swelling, or redness where you had the injection, or a headache. More serious side effects are rare. All reported side effects will be carefully monitored by the study team. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is HPV and why is it important?

HPV is a very common virus, similar to catching a cold, that can be passed during sex. Certain types can cause abnormal cell changes, which, if not treated, could sometimes lead to certain cancers, like cervical cancer.

What are 'abnormal cell changes' or HSIL?

'HSIL' stands for High-grade Squamous Intraepithelial Lesions. These are pre-cancerous changes in cells, meaning they are not cancer yet but could become cancer over time if left untreated.

Is the Gardasil 9 vaccine safe?

Yes, Gardasil 9 is a licensed vaccine that has been thoroughly tested and found to be safe for use. Common side effects are usually mild, like soreness at the injection site.

Will I know if I'm getting the real vaccine or a placebo?

No, neither you nor your study doctor will know. This is called 'double-blinded' and helps make sure the study results are fair and accurate.

How long will I be followed up in the study?

The study involves follow-up appointments and checks for up to 5 years after you start, to see the long-term effects of the treatment.