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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier De Tourcoing Tourcoing France
Centre Hospitalier Regional Universitaire Besançon France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Hopital Beaujon Clichy France
Crrdjj Hgaekubsmrb Urpimwbkggyss Rnkko Reims France
Cvn ddrxpispjztmon Epagny Metz Tessy France
Gtghnc Hgicbqbcsak Ujopbiudgqrun Pkpbw Pzortvilgrr Ez Ncpmpcihsakd Paris France
Cdx Coaxs Rycoamclqpt Lyon France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
11.01.2018

Trial locations

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.

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 ID:
2024-516098-62-00
Protocol code:
P150957
NCT ID:
NCT03296397
Trial Phase:
Therapeutic confirmatory (Phase III)

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