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

NCT03979014 | Completed Phase 3 DMC

• 1 other identifier: C/39/2018
• Study Type: interventional
• Target: 1,099
• Locations: 3 countries
• Sites: 13

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).

Conditions

Neoplasia

Keywords

Neoplasia; Cervix cancer; Vaccination; Coloscopy

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

Vaccinated Arm

EXPERIMENTAL

Add Vaccine

Biological: Gardasill 9™ vaccine

Control

NO INTERVENTION

No intervention

Interventions

Gardasill 9™ vaccine BIOLOGICAL

3 doses of Gardasill 9™ vaccine 0.5 ml administered 3 times at 0, 2 and 6 month

Vaccinated Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Imperial College London: lead
• Merck Sharp & Dohme LLC: collaborator
• Karolinska Institutet: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (13)

Helsinki University Hospital

Helsinki, 00280, Finland

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

Regionhälsan Masthugget Clinic of Obstetrics and Gynecology

Gothenburg, 413 27, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Frölunda Specialist Hospital Gynecology Clinic

Västra Frölunda, 421 37, Sweden

Location

St James's University Hospital, Leeds

Leeds, England, LS9 7TF, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, England, SE1 9RT, United Kingdom

Location

West Middlesex University Hospital

London, England, TW7 6AF, United Kingdom

Location

St. Mary's Hospital - Manchester University NHS Foundation Trust

Manchester, England, M13 9WL, United Kingdom

Location

Whittington Health NHS Trust

Middlesex, England, N19 5NF, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Royal Preston Hospital - Lancashire Teaching Hospitals NHS Trust

Fulwood, Preston, PR2 9HT, United Kingdom

Location

St Mary's Hospital - Imperial College Healthcare NHS Trust

London, SW7 2BT, United Kingdom

Location

Related Publications (1)

• Joura E, Kjaer SK, Bautista O, Luxembourg A, Saah A, Giuliano A. Effect of Prior 9-Valent Human Papillomavirus Vaccination on Subsequent Lower Genital Tract Dysplasia After Cervical Excisional Surgery. Obstet Gynecol. 2026 Jan 1;147(1):73-82. doi: 10.1097/AOG.0000000000006113. Epub 2025 Oct 30.

  PMID: 41166720 DERIVED

MeSH Terms

Conditions

Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Maria Kyrgiou, MBBS, FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 7, 2019
• Study Start: November 1, 2019
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (8); FI (2); SE (3)