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Study of HPV vaccine to prevent recurrence of External Genital Warts in previously cured patients: Comparing Human Papillomavirus vaccine versus placebo

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What is this trial about?

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

This clinical trial focuses on preventing the recurrence of External Genital Warts (EGW), a condition caused by Human Papillomavirus (HPV). The study aims to determine if vaccination with Gardasil or Gardasil 9 can reduce the rate of wart recurrence in patients who have been successfully treated for their initial wart infection.

The study compares the effectiveness of HPV vaccines against a placebo (saline solution) in preventing warts from coming back. The vaccines contain proteins that resemble parts of different HPV virus types. These proteins are made in a laboratory using special yeast cells and are combined into a liquid that can be injected into a muscle.

Treatment involves receiving three injections over a 6-month period, with each injection containing 0.5 milliliters of either the vaccine or placebo. Patients will be monitored for 12 months after their first injection to check if the warts return and to observe any reactions to the treatment. The total duration of participation in the study is one year.

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 vaccination

    You will receive the first dose of HPV vaccine or placebo through an injection in your muscle (intramuscular injection)

    This marks the beginning of your participation in the 12-month study period

  2. Step 2

    Second vaccination

    Two months after the first injection, you will receive the second dose of the vaccine or placebo

    The injection will be administered in the same way as the first dose

  3. Step 3

    Third vaccination

    Six months after the first injection, you will receive the third and final dose of the vaccine or placebo

    This completes the vaccination phase of the study

  4. Step 4

    Follow-up period

    Regular check-ups will continue for the remainder of the 12-month study period

    Medical staff will monitor for any signs of external genital warts returning

    Any local or systemic reactions to the injections will be documented

  5. Step 5

    Study completion

    The study ends 12 months after your first injection

    Final medical evaluation will be performed to assess the overall results

Who can join the trial?

9 criteria

  • Must be 18 years or older
  • Must provide written consent after having the study explained
  • Must have a confirmed history of external genital warts
  • Must be completely cured (no visible warts) for at least 2 weeks but less than 1 month before starting the study
  • For women who can become pregnant:
    • Must have a negative pregnancy test
    • Must use effective contraception during the 6-month vaccination period
    • For men:
      • Must use condoms during the 6-month vaccination period to prevent reinfection
      • Must be registered with a social security system
      • Must be able to participate for the full 12 months of the study duration

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years old
  • Current pregnancy or planning to become pregnant during the study period
  • Breastfeeding mothers
  • Previous allergic reactions to vaccines
  • Current or past history of immunodeficiency disorders (conditions that weaken the immune system)
  • Active infections requiring treatment
  • Previous HPV vaccination
  • Participation in other clinical trials within the past 30 days
  • History of severe adverse reactions (serious unwanted effects) to any vaccines
  • Presence of other sexually transmitted infections
  • Use of immunosuppressive medications (drugs that lower immune system activity)
  • History of bleeding disorders or current use of blood thinners
  • Presence of any serious medical conditions that could interfere with study participation
  • Unable to commit to the 12-month study period
  • History of drug or alcohol abuse within the past year
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Investigated drugs

HPV (Human Papilloma Virus) vaccine is a vaccine that helps protect against certain types of human papillomavirus. In this trial, it is being studied as a potential treatment to prevent the recurrence of external genital warts in patients who have already been successfully treated. The vaccine works by stimulating the immune system to produce antibodies that can help fight against HPV infections that cause genital warts.

What is already known about the treatment

HPV Quadrivalent Vaccine – A preventive vaccine administered through intramuscular injection that protects against four strains of human papillomavirus (HPV). This vaccine is currently approved and widely used in medical practice to prevent HPV infections and related conditions, including external genital warts. It works by stimulating the immune system to produce antibodies against specific HPV types, creating a defense mechanism that helps prevent viral infection and subsequent development of genital warts. The vaccine belongs to the class of viral vaccines and is being studied for its potential in preventing recurrence in patients who have been previously treated for external genital warts.

Investigated diseases

External Genital Warts - A common sexually transmitted condition caused by certain types of human papillomavirus (HPV). The condition manifests as flesh-colored bumps or groups of bumps in the genital area. These warts can vary in size and appearance, sometimes taking on a cauliflower-like shape. The warts may appear weeks or months after exposure to the virus. External genital warts can grow on the vulva, penis, groin, thighs, and around the anus. The condition can be recurring, with new warts appearing over time even after previous warts have cleared.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516098-62-00Protocol codeP150957Estimated enrolment300 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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