NOVEL study

Nonavalent prophylactic HPV vaccine (GARDASIL® 9) after local conservative treatment for cervical intra-epithelial neoplasia (CIN): a randomised controlled trial – The NOVEL trial

High grade cervical intraepithelial neoplasia (CIN), also known as high grade cervical precancer, is caused by persistent human papillomavirus (HPV) infection. These women are at high risk of developing cervical cancer. Standard treatment is a surgical procedure to remove a cone-shaped area of the cervix containing the abnormal cells.

These women are sensitive to HPV reinfection. Research has suggested that giving an HPV vaccine may reduce the rates of reinfection, development of precancer, and ultimately cervical cancer incidence.

The NOVEL trial will investigate whether the HPV vaccine Gardasil®9, when started at the time of standard treatment for CIN, will reduce subsequent HPV infections in women. If the study shows benefits in this population, the vaccine may be offered to all women planned for standard treatment. The national vaccination programme may then consider this evidence and expand vaccination as a result.