Monitoring HPV vaccine immunity using first-void urine samples
URINORM: Normalizing Antibody Detection in First-void Urine
This study is testing a new way to check if the HPV vaccine is working by using urine samples instead of more invasive methods, and it's for girls and women of different ages.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 9 Years to 70 Years |
| Sex | All |
| Sponsor | Universiteit Antwerpen Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06582654 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop standardized methods for detecting HPV-specific antibodies in first-void urine samples, which could replace more invasive sampling methods. By analyzing urine samples from various cohorts, including pre-adolescent girls and post-menopausal women, the study seeks to normalize antibody detection and reduce variability in results. Participants will self-collect urine samples over a 36-day period using a specific collection device, allowing for a non-invasive approach to monitor vaccine-induced immunity against HPV.
Who should consider this trial
Good fit: Ideal candidates include individuals vaccinated with Cervarix, Gardasil, or Gardasil9 who can provide proof of vaccination.
Not a fit: Patients who are currently pregnant, have undergone hysterectomy, or have a history of certain viral infections like HIV or Hepatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more accessible method for monitoring HPV vaccine responses.
How similar studies have performed: While initial results using first-void urine for immune response monitoring are promising, this approach is still in the process of being standardized and has not been widely tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Vaccinated with either the Cervarix, Gardasil or Gardasil9 HPV-vaccine and able to present vaccination booklet or another official document proving this. * Able to understand the information brochure and what the study is about. * Willing to give informed consent to contact his/her general practitioner and/or gynecologist to access details on their HPV vaccination schedule and, in case a woman within the screening population, cervical cancer screening results (smears, HPV tests, colposcopy, biopsy). Exclusion Criteria: * Participating in another clinical trial at the same time of participating in this study. * Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the six months prior to study enrolment. * Pregnant women. * Being positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C. * Having a 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.
Where this trial is running
Edegem, Antwerp
- University of Antwerp — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Wiebren Tjalma, MD — University Hospital, Antwerp
- Study coordinator: Alex Vorsters, Professor
- Email: alex.vorsters@uantwerpen.be
- Phone: +3232659130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.