HPV vaccine after treatment for cervical pre-invasive disease

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004662-33-GB

Enrollment

1000

Registered

2019-07-10

Start date

2019-07-12

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical intra-epithelial neoplasia

Interventions

Trade Name: Gardasil 9™ Product Name: Gardasil 9™ Product Code: V503 Pharmaceutical Form: Suspension for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Female 18-55 years old, attending hospital for localised cervical treatment for biopsy confirmed cervical intra-epithelial neoplasia (CIN) 2/3 - Written informed consent - Free of other relevant health problems as established by medical history and clinical examination - Able to comply with protocol including completion of diary cards, follow up etc Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Women treated for cervical glandular intra-epithelial neoplasia (cGIN) / adenocarcinoma in situ (AIS) - Use of other investigational/ non-registered product within 30 days prior to the 1st vaccine dose - Continuous administration of immunosuppressants prior to the 1st vaccine dose - Previous vaccination against HPV with Gardasil™ or Cervarix™ - Cancer or autoimmune disease under treatment - 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 (oral > 37.5°C / axillary temperature > 37.5°C) (will be postponed) - Pregnant women or women intending to get pregnant in the next year (if pregnant during follow-up, remaining doses will be delayed until after delivery)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the research is to show that the vaccine Gardasil 9™ can reduce HPV infection in women with high grade cervical intra-epithelial neoplasia (CIN). 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. HPV infection following localised cervical treatment will be grouped as follows, and compared between the two treatment arms: 1. Incident - an infection detected 2 years after first dose that was not detected at baseline 2. Recurrent - an infection detected 2 years after first dose that was detected at baseline but not 6 months after first dose 3. Prevalent - an infection detected 2 years after first dose that was detected at baseline, 6 months after first dose, ; Secondary Objective: Secondary objectives of the research are as follows: - To look at levels of incident, recurrent and prevalent HPV infections separately, and compare between the two treatment arms - To look at the level of HPV infections after localised cervical treatment that are oncogenic, which means able to cause development of cancer - To look at the number of patients who develop new abnormal cells on at least two-thirds of the surface of the cervix, and whether these cells are able to cause development of cancer - To examine the safety of Gardasil 9™ in terms of adverse events (side effects) ; Primary end point(s): The primary endpoint is a weighted composite of the following 3 endpoints concerning the efficacy of the Gardasil 9™ HPV-vaccine as compared to no vaccine, all of w	—

Measure

Time frame

Main Objective: The primary objective of the research is to show that the vaccine Gardasil 9™ can reduce HPV infection in women with high grade cervical intra-epithelial neoplasia (CIN). 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. HPV infection following localised cervical treatment will be grouped as follows, and compared between the two treatment arms: 1. Incident - an infection detected 2 years after first dose that was not detected at baseline 2. Recurrent - an infection detected 2 years after first dose that was detected at baseline but not 6 months after first dose 3. Prevalent - an infection detected 2 years after first dose that was detected at baseline, 6 months after first dose, ; Secondary Objective: Secondary objectives of the research are as follows: - To look at levels of incident, recurrent and prevalent HPV infections separately, and compare between the two treatment arms - To look at the level of HPV infections after localised cervical treatment that are oncogenic, which means able to cause development of cancer - To look at the number of patients who develop new abnormal cells on at least two-thirds of the surface of the cervix, and whether these cells are able to cause development of cancer - To examine the safety of Gardasil 9™ in terms of adverse events (side effects) ; Primary end point(s): The primary endpoint is a weighted composite of the following 3 endpoints concerning the efficacy of the Gardasil 9™ HPV-vaccine as compared to no vaccine, all of w

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Secondary

Measure	Time frame
Secondary end point(s): To evaluate the three components of the composite endpoint separately • Against post-treatment cervical infections (incident, recurrent, prevalent) with any oncogenic HPV types. • Against new, post-treatment, CIN2+ lesions (high-grade squamous intra-epithelial lesions (HSIL)) associated with vaccine HPV types 6/11/16/18/31/33/45/52/58. • Against new, post-treatment, CIN2+ lesions (HSIL) associated with any oncogenic HPV types. • To monitor the safety of Gardasil 9™ with the first dose given at conization.	—

Measure

Time frame

Secondary end point(s): To evaluate the three components of the composite endpoint separately • Against post-treatment cervical infections (incident, recurrent, prevalent) with any oncogenic HPV types. • Against new, post-treatment, CIN2+ lesions (high-grade squamous intra-epithelial lesions (HSIL)) associated with vaccine HPV types 6/11/16/18/31/33/45/52/58. • Against new, post-treatment, CIN2+ lesions (HSIL) associated with any oncogenic HPV types. • To monitor the safety of Gardasil 9™ with the first dose given at conization.

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Countries

Finland, Sweden, United Kingdom

Contacts

Public ContactCancer Clinical Operations Manager

Imperial Clinical Trials Unit - Cancer (ICTU-Ca)

p.badman@imperial.ac.uk4402033115203

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026