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Study on the Effectiveness of the Nonavalent HPV Vaccine in Treating Hard-to-Treat Palmar or Plantar Warts in Patients Who Have Not Responded to Two Previous Treatments

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of the nonavalent HPV vaccine, known as Gardasil 9, in treating difficult-to-treat palmar or plantar warts. These warts are located on the palms of the hands or the soles of the feet and can be challenging to treat. The study aims to see if the vaccine can lead to the complete disappearance of these warts in patients who have not had success with at least two previous treatments.

Participants in the study will receive the Gardasil 9 vaccine, which is designed to protect against nine types of the Human Papillomavirus (HPV). The vaccine will be compared to a placebo to determine its effectiveness. The study will involve a series of injections over a period of several months, with the goal of observing the complete remission of warts one month after the third injection. The study will also monitor the quality of life, pain levels, and any changes in the number of warts over time.

The trial is intended for individuals who have had palmar or plantar warts for more than a year and have tried at least two other treatments without success. The study will last for several months, and participants will be regularly assessed to track the progress of their warts and any improvements in their condition. The ultimate goal is to determine if the nonavalent HPV vaccine can be an effective treatment option for these persistent warts.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Eligibility is confirmed based on specific criteria, including age, number and size of warts, and previous treatment history.

    A negative pregnancy test is required for women of childbearing potential, along with effective contraception until the end of the vaccination period.

  2. Step 2

    First injection

    The first dose of the nonavalent HPV vaccine is administered as a suspension for injection.

    The injection is given intramuscularly.

  3. Step 3

    Second injection

    The second dose of the nonavalent HPV vaccine is administered.

    This occurs two months after the first injection.

  4. Step 4

    Third injection

    The third and final dose of the nonavalent HPV vaccine is administered.

    This occurs four months after the second injection.

  5. Step 5

    Follow-up assessments

    Complete remission of warts is evaluated seven months after the first injection.

    Quality of life, pain, and functional discomfort are assessed at the start, two months, six months, and seven months after the first injection.

Who can join the trial?

9 criteria

  • Patients must be at least 15 years and 3 months old.
  • Patients should have palmar or plantar warts for more than one year. These are warts on the palms of the hands or soles of the feet.
  • Patients must have at least 5 warts or a total wart area of at least 4 square centimeters.
  • Patients should have tried two different treatments in the past year, with the last treatment being no more than 3 weeks before joining the study.
  • Patients must have painful warts or discomfort in daily activities. This can be measured by a pain scale or specific questionnaires about hand or foot function.
  • Patients should not be taking any drugs that affect the immune system.
  • Women who can have children must have a negative pregnancy test and use effective birth control during the study and for 6 months after the vaccination period.
  • Patients must be part of a social security system.
  • Patients must be able to participate and follow the study requirements.

Who cannot join the trial?

5 criteria

  • Patients who have not failed two treatments for their warts before joining the study.
  • Patients who are not able to receive the HPV vaccine.
  • Patients who are not immunocompetent, meaning their immune system is not working properly.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Nonavalent HPV Vaccine This vaccine is designed to protect against nine different types of the human papillomavirus (HPV). In this clinical trial, it is being tested to see if it can help treat difficult-to-treat warts on the palms of the hands or the soles of the feet. These warts have not responded to at least two other treatments before the trial. The goal is to see if the vaccine can lead to the complete disappearance of these warts in patients who have a normal immune system, one month after receiving the third dose of the vaccine.

What is already known about the treatment

Nonavalent HPV Vaccine – This vaccine is administered through an injection, typically into the muscle. It is currently being studied in clinical trials for its effectiveness in treating difficult-to-treat palmar or plantar warts, particularly in patients who have not responded to two previous treatments. The vaccine is primarily used to prevent infections caused by nine types of human papillomavirus (HPV), but this trial explores its potential therapeutic use for warts. At the molecular level, the vaccine works by stimulating the immune system to recognize and fight HPV, which may help in reducing or eliminating warts. It is classified as a vaccine in pharmacology.

Investigated diseases

Cutaneous Warts – Cutaneous warts are small, rough growths on the skin caused by the human papillomavirus (HPV). They commonly appear on the hands and feet, known as palmar and plantar warts, respectively. These warts are typically harmless but can be bothersome due to their appearance and potential discomfort. They may spread through direct contact with the wart or indirectly through surfaces. Over time, warts can resolve on their own, but they may persist or recur, especially if the immune system does not effectively clear the virus.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513671-40-00Protocol codeAPHP200046Estimated enrolment146 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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