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Study of HPV antibody response in urine samples before and after HPV 9-valent vaccine in people with Human Papillomavirus infection

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on Human Papillomavirus (HPV) infection and examines how the vaccine Gardasil 9 works in the body. HPV is a common virus that can cause various health issues, including certain types of cancer. The study will look at how antibodies produced after vaccination interact with the virus particles in urine samples.

The treatment used in this study is Gardasil 9, which is a vaccine given through intramuscular injection. This vaccine protects against nine different types of HPV. Study participants will receive up to two doses of the vaccine over a period of 12 months. The vaccine contains small particles that look like the virus but cannot cause infection - these are called virus-like particles.

The main purpose of this research is to understand how the body's immune response to the vaccine works by studying urine samples before and after vaccination. Researchers will examine these samples to see how effectively the vaccine-induced antibodies can prevent the virus from infecting cells. This will help better understand how the vaccine provides protection against HPV infection.

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

    You will receive the first dose of Gardasil 9 vaccine through an injection in your muscle (intramuscular injection)

    The vaccine helps protect against several types of Human Papillomavirus (HPV)

    A urine sample and blood sample will be collected to check for HPV-specific antibodies

  2. Step 2

    Follow-up period after first dose

    Your urine sample will be tested for the presence of different types of HPV

    The laboratory will analyze how your body's immune response interacts with the virus

  3. Step 3

    Second vaccination

    You will receive the second dose of Gardasil 9 vaccine through an intramuscular injection

    Additional urine and blood samples will be collected to monitor changes in antibody levels

  4. Step 4

    Final assessment

    Your urine and blood samples will be analyzed to measure the levels of HPV-specific antibodies

    The study will evaluate how effectively your immune system responds to the vaccination

    The total duration of your participation will extend from August 2025 to August 2028

Who can join the trial?

10 criteria

  • Must be female between 18 and 45 years old at the time of signing the consent form
  • Must have tested positive for HPV16 (HPV16 is a specific type of human papillomavirus) either alone or along with other HPV types
  • Must not have any visible anogenital lesions (abnormal changes in the genital or anal area) at the time of joining the study or in the previous 12 months
  • Must never have received an HPV vaccine (a vaccine that protects against human papillomavirus)
  • Must be willing to allow the study team to review medical records, including:
    • HPV vaccination history
    • Cervical cancer screening results (tests that check for signs of cervical cancer)
    • Smear test results (a test that collects cells from the cervix)
    • Colposcopy results (a detailed examination of the cervix)
    • Biopsy results (when a small tissue sample is taken for testing)
    • Must be able to understand the study information and its purpose

Who cannot join the trial?

13 criteria

  • Male participants (only females can participate in this study)
  • Persons under 18 or over 64 years of age (study is for adults aged 18-64)
  • Previous allergic reactions to HPV vaccines (Human Papillomavirus vaccines)
  • Current pregnancy or planning to become pregnant during the study period
  • Currently breastfeeding
  • Participation in another clinical trial in the past 30 days
  • Having received any HPV vaccination in the past 6 months
  • Active infections or fever above 38°C (100.4°F) at the time of enrollment
  • Immune system disorders or taking medications that suppress the immune system
  • History of severe medical conditions that could interfere with the study
  • Unable to provide informed consent or follow study procedures
  • History of abnormal bleeding disorders
  • Current treatment for any type of cancer
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Investigated drugs

Gardasil-9 is a vaccine that helps protect against several types of Human Papillomavirus (HPV). This vaccine works by stimulating the body's immune system to produce antibodies that fight against specific types of HPV. It is used to prevent various HPV-related conditions, including certain types of cancer and genital warts. In this study, researchers are examining how the antibodies produced after vaccination interact with HPV viruses, using urine samples from participants.

What is already known about the treatment

Gardasil-9 - A preventive vaccine administered through intramuscular injection that protects against nine types of Human Papillomavirus (HPV). This FDA-approved vaccine works by stimulating the immune system to produce antibodies that target specific HPV proteins, preventing viral infection and reducing the risk of HPV-related cancers and genital warts. Gardasil-9 belongs to the class of recombinant vaccines and represents the most comprehensive HPV vaccine currently available in clinical practice, providing protection against the most common cancer-causing HPV strains.

Investigated diseases

Human Papillomavirus Infection - A common viral infection that spreads through close skin-to-skin contact, primarily affecting the genital area, mouth, and throat. The virus can infect cells in the body's mucous membranes and skin, with many people experiencing no symptoms while carrying the virus. Most infections clear on their own within two years, but some infections may persist. The virus has multiple types, with some being more likely to cause changes in infected cells. These cellular changes can develop gradually over time in the affected areas.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522053-18-00Protocol codeURVIVEEstimated enrolment50 patientsSponsorUniversity Of Antwerp

sourced from the EU Clinical Trials Register and site verification

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