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Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative The NOVEL Trial (NOVEL)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neoplasia | Biological: Gardasill 9™ vaccine | Phase 3 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vaccinated Arm
Add vaccine
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Biological: Gardasill 9™ vaccine
3 doses of Gardasill 9™ vaccine 0.5 ml administered 3 times at 0, 2 and 6 month
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No Intervention: Control
No intervention
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- 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.
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients who meet all of the following inclusion criteria will be considered eligible for this study:
- 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
- Written informed consent obtained from the subject prior to enrolment
- Free of other relevant health problems as established by medical history and clinical examination, e.g. immunosuppression
- 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:
- Use of other investigational/non-registered product within 30 days preceding the 1st vaccine dose
- Continuous administration of immunosuppressants
- Previous vaccination against HPV
- 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
- Any confirmed or suspected immunosuppressive condition, including HIV infection
- History of allergic disease or any neurologic disorders likely to interact with study vaccination
- Acute febrile disease at enrolment (will be postponed)
- 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)
| Contact: Mathew Furtado | +44 (0) 20 3311 7046 | m.furtado@imperial.ac.uk |
| Principal Investigator: | Maria Kyrgiou | Imperial College London |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 4, 2019 | ||||
| First Posted Date ICMJE | June 7, 2019 | ||||
| Last Update Posted Date | August 29, 2019 | ||||
| Estimated Study Start Date ICMJE | November 1, 2019 | ||||
| Estimated Primary Completion Date | July 31, 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative The NOVEL Trial | ||||
| Official Title ICMJE | Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia: a Randomised Controlled Trial - The NOVEL Trial | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | 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
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| Condition ICMJE | Neoplasia | ||||
| Intervention ICMJE | Biological: Gardasill 9™ vaccine
3 doses of Gardasill 9™ vaccine 0.5 ml administered 3 times at 0, 2 and 6 month
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
1000 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | July 31, 2023 | ||||
| Estimated Primary Completion Date | July 31, 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria Patients who meet all of the following inclusion criteria will be considered eligible for this study:
Exclusion criteria Patients who meet any of the following exclusion criteria will not be eligible for this study:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03979014 | ||||
| Other Study ID Numbers ICMJE | C/39/2018 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Imperial College London | ||||
| Study Sponsor ICMJE | Imperial College London | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Imperial College London | ||||
| Verification Date | August 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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