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Study on the Effectiveness of HPV 9-Valent Vaccine in Women Undergoing LEEP for High-Grade Cervical Lesions or Early Cervical Cancer

Fast replyRegistered drugNo placebo
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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 the effects of a vaccine called Gardasil 9, which is used to protect against the Human Papillomavirus (HPV). The study is particularly interested in women who have been diagnosed with high-grade cervical intraepithelial neoplasia, a condition that can lead to cervical cancer. The vaccine is designed to target nine different types of HPV, which are known to cause cervical cancer and other related diseases.

The purpose of the study is to evaluate whether receiving the HPV 9-valent vaccine before surgery can help reduce the chances of the disease coming back after surgery. Participants in the study will receive either the vaccine or a placebo. The study will follow participants over a period of time to see if the vaccine helps in reducing the recurrence of the disease and in managing infections that might occur after surgery.

Participants will be monitored for changes in their health, including the presence of HPV infections and the results of tests like the Pap test, which checks for changes in the cells of the cervix. The study aims to provide valuable information on the effectiveness of the vaccine in preventing the recurrence of cervical disease after surgical treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and health status.

    Informed consent is required, ensuring understanding of the study and agreement to participate.

  2. Step 2

    Vaccination

    The study involves receiving the HPV 9-valent vaccine, which is administered as a suspension for injection.

    The vaccine is given intramuscularly, which means it is injected into a muscle.

  3. Step 3

    Surgical procedure

    Participants undergo a surgical procedure known as loop electrosurgical excision (LEEP) to treat high-grade cervical intraepithelial neoplasia or early-stage cervical cancer.

    This procedure is part of the standard treatment for the condition being studied.

  4. Step 4

    Post-surgical follow-up

    After surgery, regular follow-up visits are scheduled to monitor recovery and assess the impact of the vaccine.

    These visits include tests such as the HPV test, pap test, and colposcopic exam to check for any signs of disease recurrence or persistent infection.

  5. Step 5

    Study completion

    The study is expected to continue until February 2028, with ongoing assessments to evaluate the long-term effects of the vaccine.

    The primary goal is to determine if the vaccine reduces the recurrence of the disease after surgery.

Who can join the trial?

7 criteria

  • Patients must be **18 years or older**.
  • Patients should have an **ECOG performance status** of **1 or less**. This is a scale that measures how well a patient can perform daily activities.
  • Patients must be diagnosed with **high-grade cervical intraepithelial neoplasia** or **initially invasive cervical cancer**. This means they have certain types of abnormal cells in the cervix.
  • Patients should not have a **fever** at the time of vaccination.
  • Patients must not have had any **previous HPV vaccination**.
  • Patients need to be able to **understand and write in Italian**.
  • Patients must sign an **informed consent** form and agree to the use of their personal data.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with cervical cancer cannot participate. Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus that connects to the vagina.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are considered part of a vulnerable population cannot participate. A vulnerable population may include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

HPV 9-valent vaccine is used in this study to evaluate its effectiveness in preventing the recurrence of cervical disease after surgical treatment. This vaccine targets nine types of human papillomavirus (HPV), which are known to cause cervical cancer and other HPV-related diseases. The study aims to see if administering this vaccine before surgery can reduce the chances of the disease coming back in women who have undergone a procedure to remove high-grade cervical lesions or early-stage cervical cancer.

What is already known about the treatment

HPV 9-valent vaccine – This vaccine is administered via injection and is currently being studied in clinical trials for its effectiveness in treating cervical cancer. It is primarily used to prevent infections caused by nine types of human papillomavirus (HPV), which are linked to cervical cancer and other HPV-related diseases. The vaccine works by stimulating the immune system to produce antibodies that target and neutralize the virus, preventing it from causing infection. It is classified as a prophylactic vaccine, designed to prevent disease rather than treat existing conditions.

Investigated diseases

Cervical Cancer – Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. It often begins with changes in the cervical cells, known as cervical intraepithelial neoplasia (CIN), which can progress to cancer if not treated. The disease is primarily caused by persistent infection with certain types of human papillomavirus (HPV). In its early stages, cervical cancer may not cause noticeable symptoms, but as it progresses, it can lead to abnormal vaginal bleeding, pelvic pain, or pain during intercourse. The progression from pre-cancerous changes to invasive cancer can take several years, but in some cases, it may occur more rapidly. Regular screening and vaccination against HPV can significantly reduce the risk of developing cervical cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513704-34-00Protocol codeHOPE 9 STUDYEstimated enrolment1 220 patientsSponsorAzienda Unita Sanitaria Locale Toscana Nord Ovest

sourced from the EU Clinical Trials Register and site verification

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