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Can the HPV vaccine stop cervical abnormalities from returning after surgery?

NCT ID NCT03979014

Prevention Sponsor: Imperial College London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving the Gardasil 9 HPV vaccine to women at the same time as surgery for abnormal cervical cells (CIN) can help clear the virus and prevent future infections. About 1,100 women aged 18-55 took part. The goal was to see if the vaccine reduces the chance of high-grade cervical changes coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gardasil 9 vaccine
What this could lead to
If it works, this could show that giving the HPV vaccine right after cervical surgery helps prevent the virus from coming back and lowers the risk of needing more treatment.
What could go wrong
This trial is completed but results are not yet widely reported, so we don't know if the vaccine made a real difference. Also, the vaccine only protects against 9 HPV types, so other types could still cause problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,099 people

The number who actually took part.

Started

Nov 2019

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

adenocarcinoma in situ cervical intraepithelial neoplasia cervical intraepithelial neoplasia grade 2/3 neoplasm Uterine Cervical Neoplasms uterine cervix carcinoma in situ

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasia

Contacts and locations

Locations

  • Frölunda Specialist Hospital Gynecology Clinic

    Västra Frölunda, 421 37, Sweden

  • Guy's and St Thomas' NHS Foundation Trust

    London, England, SE1 9RT, United Kingdom

  • Helsinki University Hospital

    Helsinki, 00280, Finland

  • Nottingham University Hospitals NHS Trust

    Nottingham, England, NG5 1PB, United Kingdom

  • Regionhälsan Masthugget Clinic of Obstetrics and Gynecology

    Gothenburg, 413 27, Sweden

  • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Trust

    Fulwood, Preston, PR2 9HT, United Kingdom

  • Sahlgrenska University Hospital

    Gothenburg, 413 45, Sweden

  • St James's University Hospital, Leeds

    Leeds, England, LS9 7TF, United Kingdom

  • St Mary's Hospital - Imperial College Healthcare NHS Trust

    London, SW7 2BT, United Kingdom

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

    Manchester, England, M13 9WL, United Kingdom

  • Tampere University Hospital

    Tampere, 33520, Finland

  • West Middlesex University Hospital

    London, England, TW7 6AF, United Kingdom

  • Whittington Health NHS Trust

    Middlesex, England, N19 5NF, United Kingdom

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