Study on HPV Vaccine After Treatment for High-Grade Cervical Lesions in Women Over 45

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What is this study about?

This clinical trial is focused on studying the effects of a vaccine called Gardasil 9 on women over 45 years old who have been treated for high-grade cervical intraepithelial lesions. These lesions are abnormal changes in the cells on the surface of the cervix, which can sometimes lead to cervical cancer if not treated. The vaccine, Gardasil 9, is designed to protect against nine types of the Human Papillomavirus (HPV), which is a common virus that can cause these lesions and other health issues.

The purpose of the study is to see if the vaccine can help women who have already been treated for these lesions to become HPV-negative, meaning the virus is no longer detectable in their system, within two years after their initial positive HPV test. Participants in the study will receive the vaccine through an injection into the muscle. The study will follow the participants over a period of up to five years, with regular check-ups to monitor their HPV status and any potential side effects from the vaccine.

Throughout the study, participants will have regular smear tests every 12 months to check for HPV. If a test comes back negative, another test will be done three years later. The study will also track any adverse events, which are any unwanted effects that occur after receiving the vaccine. These will be monitored closely to ensure the safety of the participants. The study aims to provide valuable information on the effectiveness of the Gardasil 9 vaccine in preventing the recurrence of high-grade lesions and potentially reducing the risk of developing HPV-related cancers.

1 joining the study

Upon joining the study, you will be asked to provide a signed, informed consent form. This confirms your understanding and agreement to participate in the clinical trial.

You will be assigned to one of two groups: the vaccinated patients group or the non-vaccinated patients group, based on your consent to receive the HPV vaccination with Gardasil 9.

2 initial HPV control test

An initial HPV control test will be conducted to determine your current HPV status. This test is crucial for monitoring your progress throughout the study.

3 HPV vaccination (if applicable)

If you are in the vaccinated patients group, you will receive the Gardasil 9 vaccine. This is administered as an intramuscular injection.

The vaccination schedule consists of three injections. The timing of these injections will be explained to you by the study team.

4 regular follow-up tests

You will undergo regular follow-up tests, including a smear test every 12 months, to monitor your HPV status over time.

If a test result is negative, a follow-up smear will be performed three years later.

5 monitoring adverse events

Throughout the study, any adverse events, or side effects, will be monitored. These will be assessed after each injection and through a telephone call 30 days after the third injection.

If necessary, a consultation may be arranged to address any concerns related to adverse events.

6 final assessment

The primary goal is to achieve an HPV-negative status within 24 months of the initial HPV control test.

Your progress will be evaluated at the end of the study period, which is estimated to conclude by October 2026.

Who Can Join the Study?

Patient must be a woman over the age of 45.
Patient must have been treated with a procedure called conisation for a high-grade cervical lesion. Conisation is a treatment where a small, cone-shaped piece of tissue is removed from the cervix.
Patient must have a positive HPV test at the recommended 6-month follow-up after surgery. A delay of 6 to 12 months for this test is acceptable. HPV stands for Human Papillomavirus, a common virus that can affect the cervix.
Patient must need a follow-up examination called a colposcopy, which may include a biopsy. A colposcopy is a procedure to closely examine the cervix for signs of disease.
For patients in the “vaccinated” group: Patient must have no medical reasons preventing them from receiving the HPV vaccine called Gardasil 9.
For patients in the “vaccinated” group: Patient must agree to receive the HPV vaccine Gardasil 9.
For patients in the “vaccinated” group: Patient must be part of a public health insurance program.
For patients in the “vaccinated” group: Patient must sign a form giving their informed consent to participate in the study.
For patients in the “non-vaccinated” group: Patient must either refuse the HPV vaccination or have a medical reason not to receive it.
For patients in the “non-vaccinated” group: Patient must agree to the use of their personal data for research purposes.

Who Cannot Join the Study?

Women who are not over 45 years old cannot participate.
Men cannot participate in this study.
Women who do not have high-grade cervical intraepithelial lesions cannot participate. This is a condition where there are abnormal cells on the surface of the cervix.
Women who are not chronic carriers of HPV cannot participate. HPV stands for Human Papillomavirus, a common virus that can cause changes in the cervix.
Women who have not been treated for high-grade cervical intraepithelial lesions cannot participate.
Women who have not received the HPV vaccination cannot participate. This is a vaccine that helps protect against the Human Papillomavirus.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier De Valenciennes	Valenciennes	France
Centre Francois Baclesse	Caen	France
Cjyoot Omvvi Lmprqfg	Lille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2024

Trial locations

Investigated drugs:

HPV Vaccine is a type of vaccine designed to protect against the human papillomavirus (HPV). In this clinical trial, the vaccine is used to help the body build immunity against HPV, especially after the treatment of high-grade cervical lesions. The goal is to reduce the chances of the virus coming back and to help maintain an HPV-negative status in women who have been treated for these lesions. The vaccine works by stimulating the immune system to recognize and fight the virus if it tries to infect the body again.

High-grade cervical intraepithelial lesions – High-grade cervical intraepithelial lesions are abnormal changes in the cells on the surface of the cervix. These changes are considered precancerous and are often associated with persistent infection by high-risk types of human papillomavirus (HPV). The progression of these lesions can vary; they may remain stable, regress, or progress to cervical cancer if left untreated. The lesions are typically classified as CIN 2 or CIN 3, indicating the severity of the abnormal cell growth. Over time, if the immune system does not clear the HPV infection, the risk of progression to invasive cancer increases. Regular monitoring and medical evaluation are essential to manage and assess the progression of these lesions.

Trial ID:

2024-513081-19-00

Protocol code:

HPV2-2303

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on HPV Vaccine After Treatment for High-Grade Cervical Lesions in Women Over 45

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?