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Can a vaccine prevent genital warts from returning after surgery?

NCT ID NCT02750202

Disease control Sponsor: University of Pretoria 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether giving the HPV vaccine (Gardasil) to women with large or extensive genital warts before surgery could prevent the warts from coming back. The trial included 52 women, some with HIV and some without. Researchers measured changes in wart size and antibody levels over 60 weeks to see if the vaccine boosted the immune response and improved outcomes.

What this could mean

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

Active substance
Quadrivalent HPV vaccine (Gardasil)
What this could lead to
If it works, this could offer a way to reduce the high recurrence rate of genital warts after surgery, especially in women with HIV.
What could go wrong
This is a small, completed Phase 3 trial with only 52 participants, so results may not apply to everyone. The vaccine may not prevent recurrence in all cases.

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

52 people

The number who actually took part.

Started

Jul 2018

Finished

Jul 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

16 years and older

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: * Female patient \> 16 years * Presence of vulvo vaginal genital warts: largest tumour diameter \> 3 cm OR Tumour on labia minora and labia majora OR bilateral \> 1 cm each side OR Tumour in vagina/cervix as well as on vulva \> 1 cm lesion each * HIV negative or HIV infected and CD4 ≥ 300 cells/mm3 OR viral load controlled OR anti retro-viral (ARV) compliant \> 6 months Exclusion Criteria: * Pregnant of planned pregnancy within 6 months * Not able to comprehend study method or not able to attend all study visits * Previous HPV vaccination * Active known opportunistic infection or malignancy including Pneumocystis pneumonia (PCP),Pulmonary tuberculosis (PTB), oesophageal Candida or Kaposi sarcoma or lymphoma * Known allergy to vaccines or content of vaccine * Previous radiation for genital warts

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Conditions

The condition(s) this trial relates to.

anogenital human papillomavirus infection

As listed by the trial registrant

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

Genital warts

Contacts and locations

Locations

  • Steve Biko Academic Hospital

    Pretoria, Gauteng, South Africa

  • Tygerberg Hospital

    Cape Town, Western Cape, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.