Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative The NOVEL Trial

Phase 3

• Conditions: Neoplasia
• Interventions: Biological: Gardasill 9™ vaccine

• Registration Number: NCT03979014
• Lead Sponsor: Imperial College London

Brief Summary

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).

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-29
• Study Start: 2019-11-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaccinated Arm	Gardasill 9™ vaccine	Add vaccine

Primary Outcome Measures

Name	Time	Method
Incidence of HPV infection in women with high grade cervical intra-epithelial neoplasia after vaccine Gardasil 9™ assess by laboratory test	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.

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom