Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

CONDYVAC. Efficacy study of the quadrivalent Human Papilloma Virus (HPV) vaccine to prevent recurrence of External Genital Warts (EGW) in patients who were cured in the first place

This research study, called CONDYVAC, is investigating if the HPV vaccine can prevent genital warts from returning. Participants in the study have already had their genital warts successfully treated. The study is particularly interested in whether `Gardasil 9` (a type of HPV vaccine) or `Gardasil` (an older type of HPV vaccine) can help people stay free from warts in the long term. Researchers will carefully check if warts come back. They will also keep an eye on any side effects or reactions participants might have to the vaccine. This is a large study (Phase III) to confirm previous findings and gather more information about how effective the vaccine is at preventing recurrence.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

300

Start

10 Dec 2024

External Genital Warts (EGW)

What is this study about?

Imagine you've had genital warts and they've been successfully treated – that's great news! But sometimes, these warts can come back. This research study, called CONDYVAC, is trying to find out if getting the HPV vaccine (like Gardasil or Gardasil 9) can help stop them from returning.

The Human Papillomavirus (HPV) causes genital warts. The HPV vaccine is already really good at preventing people from getting HPV in the first place, and therefore preventing warts. This study wants to see if it can also act as a protective shield for those who have already had warts and been treated, helping them stay wart-free afterwards. It's like checking if a medicine that prevents a problem can also prevent it from coming back once it's been fixed.

The main thing the researchers will be looking for is how many people stay free of warts after they've been treated and received the vaccine. They will also carefully record any side effects people might experience from the vaccine. By understanding this, doctors might be able to offer another way to help people avoid the stress of warts reappearing.

Key takeaways

This study investigates if the HPV vaccine can stop genital warts from returning after treatment.
It's for adults (18+) who have had their genital warts successfully treated.
Participants will receive an HPV vaccine (Gardasil or Gardasil 9) and be monitored.
The main goal is to see how long people stay wart-free post-vaccination.
Potential benefits include possible wart prevention; risks are mainly vaccine side effects.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. You won't be able to join if you currently have genital warts. You must have had your warts successfully treated and be clear of them before joining the study.

There might be other specific health requirements or conditions that would prevent you from taking part, but the general idea is that they are looking for adults who have recently been treated for their genital warts.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you previously had genital warts?
Have your genital warts been completely treated and are you currently clear of them?
Are you able to attend regular follow-up appointments?
Are you willing to receive the HPV vaccine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the Gardasil 9 or the Gardasil HPV vaccine, likely as a series of injections over several months, as per the usual vaccine schedule. Researchers will monitor you closely to see if your genital warts return. This will involve regular check-ups where a doctor will physically examine you to confirm if any warts have reappeared. They will also ask you about your general health and how you are feeling, looking particularly for any reactions or side effects from the vaccine. The total length of your involvement in the study will depend on the standard follow-up required after vaccination and to assess wart recurrence, but clinical trials often last for a year or more. You'll have scheduled clinic visits during this time.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving an HPV vaccine which might help prevent your genital warts from coming back, and you'll be closely monitored by medical professionals. However, as with any vaccine, there are potential risks, such as soreness, redness, or swelling where you had the injection, or other general side effects like a headache or feeling tired. Serious side effects are rare but can happen. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What are genital warts?

Genital warts are small growths that can appear on or around the genitals and anus. They are caused by certain types of the Human Papillomavirus (HPV).

What is the HPV vaccine?

The HPV vaccine helps protect against infections caused by the Human Papillomavirus (HPV), which can lead to genital warts and certain types of cancer. Gardasil and Gardasil 9 are types of HPV vaccines.

Will I get immunity from other HPV types?

Gardasil 9 protects against 9 types of HPV, and Gardasil against 4 types. These include the types most commonly linked to genital warts and also some types that can cause certain cancers. The vaccine specifically protects against these types, but not all possible HPV types.

What does 'relapse-free survival' mean?

In this study, 'relapse-free survival' means how long a person stays free of genital warts after they have been treated. The researchers want to see if the vaccine helps people stay wart-free for longer.

Will I know which vaccine I'm getting?

Sometimes in studies like this, participants are randomly assigned to receive one type of treatment or another, and you might not know which one you're getting to keep the study fair. This would be explained in more detail if you consider joining.