Actively Recruiting
Developing a First-void Urine-based Infection Model to Study HPV-specific Antibody-virion Interaction Before and After HPV Vaccination
Led by Universiteit Antwerpen · Updated on 2026-03-27
50
Participants Needed
3
Research Sites
144 weeks
Total Duration
On this page
Sponsors
U
Universiteit Antwerpen
Lead Sponsor
U
University Hospital, Antwerp
Collaborating Sponsor
AI-Summary
What this Trial Is About
The current study is an open-label, non-randomized, longitudinal exploratory trial using the licensed Gardasil 9 (9vHPV) vaccine in an off-label context to investigate biological and immunological outcomes in human papillomavirus type 16 (HPV16) positive women. Two doses of the licensed Gardasil 9 vaccine will be administered to approximately 50 women between 18 and 45 years old, who test positive for HPV16 DNA at baseline using a type-specific quantitative PCR assay, but have no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion. The primary objective of this study is to demonstrate that vaccination with a two-dose regimen of the 9vHPV vaccine reduces the viral infectivity of particles in the female genital tract of HPV16-positive women, by using first-void urine samples. The secondary objectives are to follow up HPV type-specific antibody responses in these first-void urine samples after natural infection and vaccination after one or two doses of the 9vHPV vaccine and to compare these with the responses in serum, and to monitor HPV infections in first-void urine over time. Candidates will be selected for participation based on the result of their HPV DNA test performed on a sample collected during routine screening or symptomatic (opportunistic) testing in one of the following centers: * The University Hospital of Antwerp (UZA). * The University Hospital of Leuven (UZ Leuven). * Ghent University Hospital (UZ Gent). Women are followed for up to 24 months, in which first-void urine and serum samples will be collected at different timepoints. The following laboratory procedures will be applied to reach study objectives * Assessment of HPV DNA positivity: HPV genotyping in first-void urine samples. * Assessment of HPV infectivity: Detection of HPV16 E1\^E4 spliced mRNA in HaCaT keratinocytes after infection with virions from first-void urine samples. * Assessment of HPV immunogenicity: Detection of HPV-specific antibodies in first-void urine and serum samples.
CONDITIONS
Official Title
Developing a First-void Urine-based Infection Model to Study HPV-specific Antibody-virion Interaction Before and After HPV Vaccination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female between 18 and 45 years old at consent
- Tested positive for HPV16 DNA without visible anogenital lesions or treatment in the last 12 months
- No prior vaccination with any HPV vaccine
- Able to understand the study information
- Willing to give informed consent for access to medical records including HPV vaccination and cervical cancer screening results
You will not qualify if you...
- Previously fully or partially vaccinated against HPV or planning HPV vaccination during the study
- Pregnant at consent or planning pregnancy during the study; must use effective contraception during study
- Had full hysterectomy
- Treated for any anogenital lesion within 12 months before study
- Have invasive cancer (except basocellular carcinoma) or high-risk immunocompromising conditions
- Using immunosuppressive therapy for certain diseases or local anogenital corticosteroids
- Used investigational or non-registered drugs or vaccines other than study vaccine within 30 days before first dose or planning to use during study
- Received immunoglobulin or blood products within 3 months before first dose or expected to need them between months 1-7
- Received vaccines not in study protocol within 30 days before or 30 days after each study vaccine dose
- Known allergy or severe reaction history to Gardasil 9 components or other vaccines
- Enrolled in another clinical trial of investigational agents
- Have acute moderate/severe illness or contraindications for vaccination at enrollment
- Have conditions or abnormalities that could affect study results or participant safety
- Unlikely to adhere to study procedures, keep appointments, or planning to relocate before study completion
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Antwerp University Hospital
Antwerp, Wilrijk, Belgium, 2650
Actively Recruiting
2
University Hospital Ghent
Ghent, Belgium, 9000
Actively Recruiting
3
University Hospital Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
M
Margo Bell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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