In short
There is currently 1 ongoing clinical trial investigating preventive approaches for women who have been treated for high-grade cervical lesions. This trial focuses on the use of HPV vaccination to reduce the risk of virus recurrence and potential progression to more serious conditions.
Clinical trial locations
Study on HPV Vaccine After Treatment for High-Grade Cervical Lesions in Women Over 45
This trial is investigating whether the Gardasil 9 vaccine can help women over 45 years old who have already been treated for high-grade cervical lesions. High-grade cervical lesions are abnormal changes in the cells on the surface of the cervix that are considered precancerous and are typically caused by persistent infection with the Human Papillomavirus (HPV).
Main focus: The study aims to determine if receiving the Gardasil 9 vaccine after treatment can help women achieve an HPV-negative status within two years. This means the virus would no longer be detectable in their system, potentially reducing the risk of the lesions returning or progressing to cervical cancer. The vaccine protects against nine types of HPV and is given as three injections into the muscle over a period of time.
Who can participate (inclusion criteria):
- Women over 45 years of age
- Previously treated with conisation (a procedure where a cone-shaped piece of tissue is removed from the cervix) for high-grade cervical lesions
- Have a positive HPV test result at the recommended 6-month follow-up after surgery (acceptable with a delay of 6 to 12 months)
- Need a follow-up colposcopy examination (a procedure to closely examine the cervix), which may include a biopsy
- For those receiving the vaccine: must have no medical reasons preventing vaccination, must agree to receive Gardasil 9, be part of a public health insurance program, and provide informed consent
- For those not receiving the vaccine: must either refuse vaccination or have a medical reason not to receive it, and agree to the use of their personal data for research
Who cannot participate (exclusion criteria):
- Women who are 45 years old or younger
- Men (this study is specifically for women)
- Women without high-grade cervical lesions
- Women who are not chronic carriers of HPV
- Women who have not been treated for high-grade cervical lesions
- Women who have not received HPV vaccination (note: this refers to the study's control group requirements)
Study procedures: Participants will be divided into two groups: those receiving the vaccine and those not receiving it. Women in the vaccinated group will receive three Gardasil 9 injections according to a specified schedule. All participants will undergo regular follow-up testing, including smear tests every 12 months to monitor their HPV status. If a test comes back negative, another test will be performed three years later. The study will closely monitor any side effects from the vaccine through assessments after each injection and a telephone follow-up 30 days after the third injection. The study will follow participants for up to five years, with an estimated conclusion date of October 2026.
Investigational treatment: The HPV vaccine Gardasil 9 is designed to stimulate the body's immune system to produce antibodies that can recognize and fight the virus if exposed in the future. While HPV vaccines are currently used in medicine to prevent HPV infections, this study is specifically investigating whether vaccination after treatment can help maintain an HPV-negative status in women who have already developed and been treated for high-grade cervical lesions.
Summary
Currently, only one clinical trial is active for women who have been treated for benign cervical lesions associated with HPV infection. This trial is being conducted in France and focuses specifically on women over 45 years of age, a population that has historically received less attention in HPV vaccination studies. The trial compares outcomes between women who receive the Gardasil 9 vaccine after treatment and those who do not, with the goal of understanding whether post-treatment vaccination can prevent viral recurrence. The study's five-year follow-up period will provide valuable long-term data on the effectiveness of this preventive approach in reducing the risk of lesion recurrence and potential progression to more serious conditions.
