In short
Currently, there is 1 ongoing clinical trial investigating new approaches to prevent the recurrence of anogenital warts. This trial is evaluating the use of HPV vaccination in patients who have been successfully treated for their initial infection. The study is being conducted in France and aims to determine whether vaccination can help prevent warts from returning after treatment.
Clinical trial locations
Study of HPV vaccine to prevent recurrence of External Genital Warts in previously cured patients: Comparing Human Papillomavirus vaccine versus placebo
This clinical trial is investigating whether HPV vaccination can help prevent genital warts from coming back in patients who have already been successfully treated. The study compares the effectiveness of Gardasil or Gardasil 9 vaccines against a placebo (inactive saline solution).
Who can participate:
- Adults between 18 and 65 years of age
- People with a confirmed history of external genital warts who have been completely cured for at least 2 weeks but less than 1 month
- Women of childbearing age must have a negative pregnancy test and use effective contraception during the 6-month vaccination period
- Men must use condoms during the 6-month vaccination period to prevent reinfection
- Participants must be able to commit to the full 12-month study period
- Must be registered with a social security system
Who cannot participate:
- Pregnant women, those planning pregnancy during the study, or breastfeeding mothers
- People who have had previous allergic reactions to vaccines or previous HPV vaccination
- Those with current or past immunodeficiency disorders or using medications that weaken the immune system
- Individuals with active infections requiring treatment or other sexually transmitted infections
- People with bleeding disorders or currently using blood thinners
- Those with serious medical conditions that could interfere with study participation
- Anyone who participated in other clinical trials within the past 30 days
- People with a history of drug or alcohol abuse within the past year
What the trial involves:
The main goal of this study is to determine whether HPV vaccination can reduce the rate at which genital warts return after successful treatment. Participants will receive three injections over a 6-month period. Each injection contains 0.5 milliliters of either the HPV vaccine or placebo, administered into a muscle.
The treatment schedule includes:
- First injection at the start of the study
- Second injection 2 months after the first dose
- Third injection 6 months after the first dose
Throughout the study, participants will have regular check-ups where medical staff will monitor for any signs of warts returning and document any reactions to the injections. The total duration of participation is 12 months from the first injection.
Investigational treatment:
The study uses HPV vaccine (Gardasil or Gardasil 9), which contains laboratory-made proteins that resemble parts of different HPV virus types. These proteins are produced using special yeast cells and combined into a liquid for injection. The vaccine works by stimulating the immune system to produce antibodies that can help fight against HPV infections that cause genital warts.
Summary
This single ongoing trial represents an important investigation into preventing the recurrence of anogenital warts through vaccination. The study focuses on a specific patient population who have recently been cured of their initial infection, examining whether HPV vaccination during this window period can provide protection against future outbreaks. The trial is being conducted in France and uses established HPV vaccines that are already approved for preventing initial HPV infections. The research aims to determine whether these vaccines can also play a role in secondary prevention, potentially offering a new approach to managing this recurring condition.
