Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia (NOVEL)

April 30, 2026 updated by: Imperial College London

Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia: a Randomised Controlled Trial - The NOVEL Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The human papilloma virus (HPV) can cause high grade intra-epithelial neoplasia (CIN) in women, a condition where there are abnormal cells on 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 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.

Study Type

Interventional

Enrollment (Actual)

1099

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00280
        • Helsinki University Hospital
      • Tampere, Finland, 33520
        • Tampere University Hospital
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital
      • Gothenburg, Sweden, 413 27
        • Regionhälsan Masthugget Clinic of Obstetrics and Gynecology
      • Västra Frölunda, Sweden, 421 37
        • Frölunda Specialist Hospital Gynecology Clinic
  • United Kingdom
      • London, United Kingdom, SW7 2BT
        • St Mary's Hospital - Imperial College Healthcare NHS Trust
    • England
      • Leeds, England, United Kingdom, LS9 7TF
        • St James's University Hospital, Leeds
      • London, England, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust
      • London, England, United Kingdom, TW7 6AF
        • West Middlesex University Hospital
      • Manchester, England, United Kingdom, M13 9WL
        • St. Mary's Hospital - Manchester University NHS Foundation Trust
      • Middlesex, England, United Kingdom, N19 5NF
        • Whittington Health NHS Trust
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
    • Preston
      • Fulwood, Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Patients who meet all of the following inclusion criteria will be considered eligible for this study:

  1. Female (18-55y) attending for local treatment for presumed CIN2 (cytological and colposcopy impression) OR presumed CIN3 (cytological and colposcopy impression) OR presumed cGIN/AIS (cytological and colposcopy impression) OR biopsy-confirmed CIN2 OR biopsy-confirmed CIN3 OR biopsy-confirmed CGIN/AIS
  2. Written informed consent obtained from the subject prior to enrolment
  3. Free of other relevant health problems as established by medical history and clinical examination, e.g. immunosuppression
  4. Patients who the investigator believes can and will comply with the protocol requirements (e.g. attendance at clinic appointments and return for follow-up visits)

Exclusion criteria

Patients who meet any of the following exclusion criteria will not be eligible for this study:

  1. Use of other investigational/non-registered product within 30 days preceding the 1st vaccine dose
  2. Continuous administration of immunosuppressants
  3. Previous vaccination against HPV
  4. Cancer or autoimmune disease under treatment. Patients who have a history of cancer or autoimmune disease but are not currently being treated for the condition will be included
  5. Any confirmed or suspected immunosuppressive condition, including HIV infection
  6. History of allergic disease or any neurologic disorders likely to interact with study vaccination
  7. Acute febrile disease at enrolment (will be postponed)
  8. Pregnant women or women intending to get pregnant during the next 6 months (if pregnant during follow-up, remaining doses will be delayed until after delivery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Vaccinated Arm
Add Vaccine
Biological: Gardasill 9™ vaccine
3 doses of Gardasill 9™ vaccine 0.5 ml administered 3 times at 0, 2 and 6 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of HPV infection in women with high grade cervical intra-epithelial neoplasia after vaccine Gardasil 9™ assess by laboratory test
Time Frame: 2 years after first dose of vaccine
High grade CIN is 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). Gardasil 9™ will be given at the same time as localised cervical treatment, a procedure which uses a scalpel or laser to remove a cone-shaped piece of the cervix containing the area with abnormal cells.
2 years after first dose of vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Karolinska Institutet
Merck Sharp & Dohme LLC
National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Maria Kyrgiou, MBBS, FRCP, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

September 5, 2025

Study Completion (Actual)

September 5, 2025

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C/39/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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