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Study on the Safety and Immune Response of the 9-Valent HPV Vaccine in Women Living with HIV

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What is this trial about?

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

This clinical trial is focused on studying the effects of a vaccine called Gardasil 9 in women who are living with HIV and are receiving treatment. HIV, or Human Immunodeficiency Virus, is a virus that attacks the body's immune system. The vaccine being studied is designed to protect against nine types of the Human Papillomavirus (HPV), which is a common virus that can lead to certain types of cancer. The purpose of the study is to understand how well the vaccine works in producing an immune response in these women.

Participants in the study will receive the Gardasil 9 vaccine, which is given as an injection. The study will monitor the participants over a period of time to see how their bodies respond to the vaccine. This includes checking for the production of antibodies, which are proteins made by the immune system to help fight infections. The study will also look at the safety of the vaccine in this group of women.

The study will take place over several months, with key assessments happening at the start and then again at seven months. The goal is to see if the vaccine can produce a strong immune response, similar to what is seen in people without HIV. This information will help determine if the vaccine is effective and safe for women living with HIV.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial vaccination

    Receive the first dose of the Gardasil 9 vaccine. This vaccine is a suspension for injection and is administered through intramuscular use.

    The vaccine is designed to protect against nine types of the human papillomavirus (HPV).

  2. Step 2

    Second vaccination

    Receive the second dose of the Gardasil 9 vaccine.

    This dose is part of the vaccination schedule to ensure the development of immunity against HPV.

  3. Step 3

    Third vaccination

    Receive the third and final dose of the Gardasil 9 vaccine.

    This completes the vaccination series, which is crucial for achieving the desired immune response.

  4. Step 4

    Monitoring and follow-up

    Undergo regular monitoring to assess the immune response to the vaccine.

    The primary objective is to measure the rate of seroconversion, which is the development of detectable antibodies in the blood, against the nine HPV genotypes included in the vaccine.

    This monitoring occurs at baseline and again at month 7 to evaluate the effectiveness of the vaccination.

Who can join the trial?

5 criteria

  • Must be a woman who is HIV-positive. This means the person has the human immunodeficiency virus.
  • Age should be between 15 and 40 years old.
  • Must have an undetectable HIV viral load for at least 6 months. This means the amount of HIV in the blood is so low that it can't be measured by standard tests. It should be less than 400 copies per milliliter, confirmed by at least two tests 6 months apart.
  • No plans for pregnancy in the next 7 months and must use some form of contraception. This can include condoms, hormonal methods like birth control pills, or an intrauterine device (IUD).
  • Must have signed an informed consent form. This means agreeing to participate in the study after understanding all the details and risks.

Who cannot join the trial?

4 criteria

  • Women who are not living with HIV (a virus that affects the immune system) and are not receiving treatment for it.
  • Women who are not being treated with antiretroviral medications (drugs used to manage HIV).
  • Individuals who are not female, as the study is only for women.
  • Women who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

9-valent HPV Vaccine This vaccine is designed to protect against nine different types of the Human Papillomavirus (HPV), specifically types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The vaccine works by stimulating the body's immune system to produce neutralizing antibodies, which help prevent infection from these HPV types. This is particularly important for HIV-positive women, as they may be at higher risk for HPV-related complications. The study aims to evaluate the vaccine's ability to induce a strong immune response and ensure its safety in this population.

What is already known about the treatment

9-valent HPV Vaccine – This vaccine is administered via injection and is designed to protect against nine types of human papillomavirus (HPV). It is currently used in clinical settings and is well-documented in medical literature, particularly for its role in preventing HPV-related diseases. The main therapeutic indication is to induce an immune response in women living with HIV who are undergoing antiretroviral treatment. At the molecular level, the vaccine works by stimulating the body's immune system to produce neutralizing antibodies against specific HPV genotypes, thereby preventing infection. It is classified as a prophylactic vaccine, aimed at preventing disease rather than treating it.

Investigated diseases

  • Human Immunodeficiency Virus (HIV) Infection

    HIV is a virus that attacks the body's immune system, specifically the CD4 cells (T cells), which help the immune system fight off infections. Over time, HIV can destroy so many of these cells that the body can't fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing injection drug equipment. Without treatment, HIV can gradually weaken the immune system, leading to acquired immunodeficiency syndrome (AIDS). The progression of the disease varies among individuals, but it typically involves an initial acute infection phase, followed by a chronic phase that can last for many years.

  • Human Papillomavirus (HPV) Infection

    HPV is a group of more than 200 related viruses, some of which are spread through direct sexual contact. Certain types of HPV can cause warts on different parts of the body, while others can lead to cancers, such as cervical cancer. The virus infects the skin and mucous membranes, and many people with HPV do not develop symptoms or health problems. In most cases, the body's immune system clears the virus naturally within two years. However, when the virus persists, it can cause cell changes that may lead to cancer over time.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-520419-42-00Protocol codeThe papillon studyEstimated enrolment169 patientsSponsorCHU Saint Pierre

sourced from the EU Clinical Trials Register and site verification

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