Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of pre-surgical HPV9-valente vaccination in women treated with loop electrosurgical excision (LEEP) for high-grade cervical intraepithelial neoplasia (CIN2+) up to cervical cancer initially invasive (FIGO IA1) - HOPE 9 STUDY

This study, called HOPE 9, is investigating if the HPV vaccine Gardasil 9 can stop abnormal cervical cells from returning after women have had surgery (LEEP for CIN2+). It’s a large-scale study where women are randomly put into two groups: one receiving the vaccine and the other a dummy treatment (placebo). Neither the women nor their doctors will know who received what. The main goal is to see if the vaccine reduces how many women have these cell changes come back. Researchers will also look at how quickly HPV infections clear up and how long it takes for screening tests (like smear tests) to show normal results after surgery, comparing the vaccinated group to the placebo group.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Azienda Unita Sanitaria Locale Toscana Nord Ovest

Enrolment target

1,220

Start

24 Jun 2024

cervical cancer

What is this study about?

Imagine you've had surgery called LEEP to remove abnormal cells from your cervix, which are often caused by the Human Papillomavirus (HPV). This study wants to find out if getting an HPV vaccine, specifically Gardasil 9, before this surgery can help make sure those abnormal cells don't come back. The vaccine targets nine types of HPV that can cause these changes and even cervical cancer.

The HOPE 9 study is a 'Phase III' trial, which means it's a large, important study designed to confirm if a new treatment works and is safe. Participants are randomly assigned to either receive the Gardasil 9 vaccine or a dummy injection (placebo). This is done so researchers can fairly compare the two groups and be confident that any differences they see are due to the vaccine and not other factors. Everyone involved, including the patients and their doctors, won't know who received the vaccine and who received the placebo.

The main aim is to see if women who get the vaccine are less likely to have abnormal cells return after their surgery compared to those who received the placebo. The study also looks at how the vaccine might help clear up HPV infections after surgery and how quickly follow-up tests, like smear tests, return to normal. This research is important because it could lead to better ways to prevent cervical cell changes from recurring, helping women stay healthier after treatment.

Key takeaways

Exploring if HPV vaccine prevents abnormal cervical cells from returning after surgery.
Compares Gardasil 9 vaccine to a dummy treatment (placebo).
Study is for women who've had certain abnormal cervical cell changes or early cancer.
Aims to reduce the chance of needing further treatment.
Participants and doctors won't know who receives vaccine vs. placebo.

Who may be eligible?

This study is looking for women who are 18 years old or older. You would be considered if you have been diagnosed with significant abnormal cell changes in your cervix, known as CIN2+ (Cervical Intraepithelial Neoplasia Grade 2 or higher), or if you have very early-stage cervical cancer (called FIGO IA1).

The reason for these specific requirements is that the study aims to understand how the vaccine works in women who are already facing these particular health challenges and are preparing for LEEP surgery. It's important that participants fit these criteria so the study results are relevant to this group of women.

Quick self-check

Are you female?
Are you 18 years old or older?
Have you been diagnosed with CIN2+, CIN3, or CIS (severe abnormal cervical cells)?
Have you been diagnosed with very early-stage cervical cancer (FIGO IA1)?
Are you scheduled for LEEP surgery for these conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be randomly assigned to either receive the Gardasil 9 vaccine or a placebo (a dummy injection that looks like the vaccine). You would receive injections before your planned LEEP surgery. There will be follow-up appointments where doctors will check for any recurrence of abnormal cells and perform tests like HPV tests and smear tests to see how you're doing. The study will monitor how long it takes for HPV infections to clear up and for your screening tests to return to normal. The total duration of participations and number of visits are not specified, but typically, these types of studies involve several visits over a period of months to a few years to track long-term effects.

Potential risks and benefits

Taking part in this study could potentially reduce your chance of abnormal cervical cells returning after surgery. However, there's also the chance you might receive the placebo and not the active vaccine. As with any vaccine, you might experience side effects such as soreness, redness, or swelling where the injection was given, or mild fever. The study procedures might involve additional clinic visits and tests beyond your standard care. Remember, you can always choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Italy

Common questions

What is HPV and cervical cancer?

HPV (Human Papillomavirus) is a common virus that can cause abnormal cell changes in the cervix, which can sometimes lead to cervical cancer if not treated.

What is the LEEP surgery?

LEEP is a common procedure that uses a heated wire loop to remove abnormal cells from the cervix.

What is Gardasil 9?

Gardasil 9 is a vaccine designed to protect against nine types of HPV that are responsible for most cases of cervical cancer and other HPV-related diseases.

What does 'double-blind' mean?

Double-blind means that neither you nor your doctor will know whether you are receiving the active vaccine or a dummy injection (placebo).

Why is this study important?

This study aims to see if the Gardasil 9 vaccine can help prevent abnormal cervical cells from returning after surgery, potentially improving long-term health for women.