In short
There is currently 1 ongoing clinical trial investigating prevention strategies for women who have been treated for high-grade cervical lesions caused by HPV infection. The trial is evaluating whether vaccination can help prevent the virus from returning after treatment.
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 who have been treated for high-grade cervical lesions maintain an HPV-negative status over time. High-grade cervical intraepithelial lesions are abnormal cell changes on the cervix surface that can sometimes develop into cervical cancer if not treated. These changes are typically caused by persistent infection with Human Papillomavirus.
Who can participate:
- Women over 45 years old who have been treated with conisation, a procedure where a cone-shaped piece of tissue is removed from the cervix
- Women who have a positive HPV test at the recommended 6-month follow-up after surgery, with a delay of up to 12 months acceptable
- Women who require a follow-up colposcopy examination, which is a close examination of the cervix that may include a biopsy
- For those in the vaccinated group: women who have no medical reasons preventing vaccination, agree to receive Gardasil 9, have public health insurance, and provide informed consent
- For those in the non-vaccinated comparison group: women who either refuse vaccination or have medical reasons not to receive it, and agree to the use of their data for research
Who cannot participate:
- Women who are 45 years old or younger
- Men
- 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
Main focus of the trial:
The study aims to determine whether the Gardasil 9 vaccine, which protects against nine types of HPV, can help treated women become and remain HPV-negative within two years after their initial positive test. Participants will be followed for up to five years with regular check-ups to monitor their HPV status and any potential side effects.
The vaccine is given as three injections into the muscle. Participants will have smear tests every 12 months to check for HPV. If a test is negative, another test will be conducted three years later. The study carefully monitors any unwanted effects that occur after vaccination to ensure participant safety.
Investigational treatment:
The trial uses the HPV vaccine (Gardasil 9), which is designed to stimulate the immune system to recognize and fight HPV if it tries to infect the body again. The vaccine works by helping the body build immunity against the virus, with the goal of reducing the chances of the virus returning after treatment and maintaining an HPV-negative status.
Summary
Currently, there is one clinical trial available for women over 45 who have been treated for high-grade cervical lesions related to HPV infection. This trial is taking place in France and focuses on evaluating the preventive potential of the Gardasil 9 vaccine in helping women remain HPV-negative after treatment. The study represents an important investigation into whether vaccination can reduce the risk of virus recurrence and potentially lower the risk of developing HPV-related cancers in this specific age group. Women interested in participating should meet specific criteria related to their treatment history and HPV status.
