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Developing a first-void urine-based infection model to assess HPV virion infectivity after vaccination.
EU CTIS ID: 2025-522053-18-00
What this study is testing
To examine the interaction between vaccine-induced HPV type-specific antibodies and HPV virions in an in vitro infection model using first-void urine samples.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Females between 18 and 45 years old (including both limits) at the time of signing the informed consent form.
- Tested positive for HPV16 (singular or co-infection) but no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion or within the last twelve months before inclusion.
- No prior vaccination with a prophylactic HPV vaccine.
- Willing to give informed consent to the study team to access medical records, including details on their HPV vaccination schedule and cervical cancer screening results (smears, HPV tests, colposcopy, biopsy).
- Ability to understand the information brochure and what the study is about.
You likely can't join if
- Pregnant at the time of signing informed consent or planning to become pregnant within the full duration of the study.
- Concurrently enrolled in another clinical study of investigational agents.
- Acute disease or contraindications for vaccination at the time of enrolment.
- History or current evidence of any condition or abnormality that might confound the results of the study or is not in the best interest of the individual to participate, in the opinion of the investigator.
- Unlikely to adhere to the study procedures, keep appointments, or are planning to relocate from the area prior to completion of the study.
- Full hysterectomy.
See the full eligibility criteria
- Females between 18 and 45 years old (including both limits) at the time of signing the informed consent form.
- Tested positive for HPV16 (singular or co-infection) but no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion or within the last twelve months before inclusion.
- No prior vaccination with a prophylactic HPV vaccine.
- Willing to give informed consent to the study team to access medical records, including details on their HPV vaccination schedule and cervical cancer screening results (smears, HPV tests, colposcopy, biopsy).
- Ability to understand the information brochure and what the study is about.
- Pregnant at the time of signing informed consent or planning to become pregnant within the full duration of the study.
- Concurrently enrolled in another clinical study of investigational agents.
- Acute disease or contraindications for vaccination at the time of enrolment.
- History or current evidence of any condition or abnormality that might confound the results of the study or is not in the best interest of the individual to participate, in the opinion of the investigator.
- Unlikely to adhere to the study procedures, keep appointments, or are planning to relocate from the area prior to completion of the study.
- Full hysterectomy.
- Anogenital lesion treated in the last twelve months before participating in the study.
- Invasive cancer (except basocellular carcinoma) or other immunocompromising conditions as described as high-risk in the latest scientific guidelines from Sciensano.
- Use of immunosuppressive therapy for inflammatory bowel disease, rheumatological disorders, neuromyelitis optica, sarcoidosis, adenocarcinoma in situ, or use of local anogenital corticosteroids.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planning to use during the study period.
- Immunoglobulins or other blood products from day 1 until month 7 of the study.
- Any vaccine not foreseen in the study protocol administered in the period beginning 30 days preceding each dose of the study vaccine and ending one month (minimum 30 days) after each dose of the study vaccine.
- Known allergy for any component of the Gardasil9TM vaccine.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.