AuthorisedPhase III and phase IV (Integrated)Interventional

Prospective longitudinal study on immunogenicity, induction of cellular immune responses and safety of vaccination against HPV with the 9valent vaccine in HIV-positive women The Papillon study

This study, called 'The Papillon study,' is looking into how well a vaccine called Gardasil 9 works in women who have HIV and are already receiving treatment. Gardasil 9 protects against nine types of Human Papillomavirus (HPV), a common virus that can cause conditions like cervical cancer. Researchers want to see how strongly these women's immune systems respond to the vaccine, meaning how well their bodies create protection against HPV. They are also checking that the vaccine is safe for them. The main goal is to see if at least 80% of these women develop good protection against HPV after getting the vaccine, especially for those who haven't been exposed to these HPV types before.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

CHU Saint Pierre

Enrolment target

169

Start

30 Jan 2025

giving a commercially available vaccine to women with HIV under treatment women living with HIV traeted by antiretroviral

What is this study about?

You might have heard about the HPV vaccine, which helps protect against Human Papillomavirus. HPV is a very common virus that can cause certain health problems, including some cancers, like cervical cancer. This study is specially designed for women who have HIV and are currently receiving treatment for it.

This study is called 'The Papillon study,' and its main purpose is to see how well the Gardasil 9 vaccine works in women with HIV. The Gardasil 9 vaccine is designed to protect against nine different types of HPV. Researchers want to understand if these women's bodies create a strong immune response, which means their bodies learn to fight off these HPV types. They'll also be carefully checking that the vaccine is safe for women with HIV.

By taking part, you would be helping doctors and scientists understand more about how to protect women with HIV from HPV. This is important because having HIV can sometimes affect how well your body responds to vaccines. The results of this study could help improve health guidelines and care for women with HIV in the future.

Key takeaways

Study confirms safety and effectiveness of HPV vaccine (Gardasil 9) in women with HIV.
Aims to see how well the body's immune system responds to the vaccine.
For women aged 18+ who are living with HIV and receiving treatment.
Participation involves vaccine injections and blood tests for follow-up.
Contributes to better understanding and care for women with HIV and HPV.
Your decision to participate is entirely voluntary.

Who may be eligible?

This study is looking for women who are 18 years old or older. You must also be living with HIV and currently receiving treatment for your HIV.

More specifically, the study is interested in women whose bodies haven't yet been exposed to the nine types of HPV that the Gardasil 9 vaccine protects against. The researchers will check for this before you start the vaccine injections.

If you meet these main points, the researchers will check other details to make sure the study is a good fit for you. This helps make sure the results are accurate and that everyone in the study is safe.

Quick self-check

Are you a woman aged 18 or older?
Do you have HIV?
Are you currently receiving treatment for your HIV?
Have you not been exposed to the specific HPV types for which the vaccine protects (this will be checked by the study team)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive the Gardasil 9 vaccine. This is given as an injection, just like other vaccines. The researchers will take blood samples at the beginning of the study to see if you have any existing protection against HPV. You'll then receive the vaccine over a period of time. Another blood test will be taken about seven months after the first vaccine dose to see how well your body has responded and created protection against HPV.

Throughout the study, the medical team will keep a close eye on your health to make sure you are feeling well and that the vaccine is safe for you. They will explain exactly how many visits you would need to make and over what period of time. The total duration of your active participation, which includes the vaccinations and follow-up checks, is expected to be several months.

Potential risks and benefits

Participating in this study might offer you the potential benefit of protection against nine types of HPV, which can lead to certain cancers. However, as with any vaccine or medication, there could be some risks, such as temporary side effects like soreness or redness where you received the injection. The study team will explain all known potential risks and benefits in detail. Remember, choosing to participate is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Belgium

Common questions

What is HPV?

HPV, or Human Papillomavirus, is a very common virus that can affect the skin and moist membranes of the body. Certain types can cause warts, and others can lead to serious conditions like some cancers.

What is Gardasil 9?

Gardasil 9 is a vaccine designed to protect against nine types of HPV that are responsible for the majority of HPV-related disease, including most cases of cervical cancer and genital warts.

Why a special study for women with HIV?

People living with HIV can sometimes have a weaker immune system, which might affect how well their bodies respond to vaccines. This study helps doctors understand if the HPV vaccine works effectively for them.

Will I know if I'm protected after the vaccine?

The study will test your blood to see how well your body has produced protective substances (antibodies) against HPV after you've received the vaccine. This helps researchers understand the vaccine's effectiveness.

Will my HIV treatment change?

No, this study is for women who are already on stable HIV treatment. The study is designed to see how the HPV vaccine works alongside your current HIV medication, not to change it.