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

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ClinicalTrials.gov Identifier: NCT03979014
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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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).

Condition or disease Intervention/treatment Phase
Neoplasia Biological: Gardasill 9™ vaccine Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The patients and clinicians will not be blinded but the laboratory staff performing the HPV assays on vaccinated and non-vaccinated arms will be blinded
Primary Purpose: Prevention
Official Title: Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia: a Randomised Controlled Trial - The NOVEL Trial
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
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
No Intervention: Control
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979014


Contacts
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Contact: Mathew Furtado +44 (0) 20 3311 7046 m.furtado@imperial.ac.uk

Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Maria Kyrgiou Imperial College London
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03979014    
Other Study ID Numbers: C/39/2018
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
neoplasia
cervix cancer
vaccination
Additional relevant MeSH terms:
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Neoplasms