The NOVEL trial aims to explore if there is value in vaccinating women against HPV at the time of local treatment for cervical precancer
What is the NOVEL trial?
The NOVEL trial aims to explore the value in vaccinating women against HPV at the time of local treatment for cervical precancer. This trial is funded predominantly by the National Institute of Health Research in the UK. The trial has been approved by local ethics boards in the UK, Sweden, and Finland. All handling of data will comply to EU General Data Protection Regulations (GDPR).
The NOVEL trial has opened recruitment in February 2020. We are pleased to report that we are opening a number of recruiting sites in the United Kingdom, Sweden and Finland. Thank you all for showing an interest in participating in the trial.
If you are eligible and decide to take part, you will be one of the 1000 women recruited into the study from the UK, Finland and Sweden.
News from the NOVEL trial
As of 3rd of March 2021, there twelve actively recruiting sites across the UK, Sweden, and Finland.
A total of 533 patients have been recruited onto the study, and recruitment rates continue to increase.
The NOVEL study has continued to be active throughout the COVID-19 pandemic, with all sites operating in a COVID-safe environment, and recruitment predicted to end by the end of 2021.
Preventing cervical cancer together
We are looking for women that have been diagnosed with high-grade precancerous lesions of the cervix that are planned to have local cervical treatment (conisation). We are not certain if the vaccine is of benefit for these women when given at the time of treatment. The NOVEL trial will explore whether a specific HPV-vaccine, called Gardasil®9, when started at the time of local treatment, will reduce subsequent HPV infections in women with high-grade precancer. If the study shows benefits, this vaccine may be offered to all women planned for local treatment. The national vaccination programme may then consider this evidence and expand vaccination to women after local treatment as a result.
- The NOVEL trial is looking at established vaccines in a high-risk population that is due to be treated for high-grade precancer
- We’d like to help these women at higher risk of recurrent cervical abnormalities in the future
- We’d like to accelerate the impact of vaccination and potentially save lives
Together we can prevent cervical cancer
You may be eligible to take part in the NOVEL trial if:
1. You are due to have local treatment (loop excision/LLETZ) for high-grade precancer
2. You are a patient at one of the participating NOVEL trial centres
3. You meet the study’s specific eligibility criteria
