NOVEL

• Research type

  Research Study

• Full title

  NOVEL: Nonavalent HPV vaccine after local conservative treatment for cervical pre-invasive disease - a randomised controlled trial

• IRAS ID

  251807

• Contact name

  Maria Kyrgiou

• Contact email

  m.kyrgiou@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Eudract number

  2018-004662-33

• Duration of Study in the UK

  4 years, 2 months, 31 days

• Research summary

  The human papilloma virus (HPV) can cause high grade intra-epithelial neoplasia (CIN) in women, a condition where there are abnormal cells on at least two-thirds of the surface of the cervix (the opening to the vagina from the womb). High grade CIN can develop into cervical cancer, and standard treatment is a surgical procedure called conisation, where a scalpel or laser is used to remove a cone-shaped piece of the cervix containing the abnormal cells.

  HPV vaccines are routinely used in adolescent girls as part screening programmes to prevent cervical cancer (12-18 years of age in the UK). The researchers involved in this new study are interested in whether giving a HPV vaccine to women at the same time as conisation can lead to a greater rate of HPV clearance compared to conisation on its own, and a result reduce the occurrence of further infection and high grade CIN. The study will do this by using a specific HPV vaccine called Gardasil 9™ which protects against 9 types of HPV infection (types 6, 11, 16, 18, 31, 33, 45, 52 and 58).

  The NOVEL study will compare the vaccine approach with standard treatment in a randomised controlled trial, where eligible women will be randomly allocated to one of the following:

  Arm 1: Local Cervical treatment and vaccination with Gardasil 9, followed by additional vaccinations 2 and 6 months after conisation
  Arm 2: Local Cervical Treatment and Observation

  This study is for women aged 18-55 years of age with biopsy confirmed high-grade CIN. 1000 women will be recruited at colposcopy clinics in the UK, Finland and Sweden. Women will be followed up for a maximum of two and a half years.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  19/LO/0785

• Date of REC Opinion

  29 May 2019

• REC opinion

  Favourable Opinion