Actively Recruiting
URINORM: Normalizing Antibody Detection in First-void Urine to Monitor HPV Vaccine Immunity
Led by Universiteit Antwerpen · Updated on 2024-09-03
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universiteit Antwerpen
Lead Sponsor
U
University Hospital, Antwerp
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how to improve the monitoring of vaccine-induced immunity against Human Papillomavirus (HPV) using a non-invasive method. This study focuses on developing reliable ways to detect HPV-specific antibodies in first-void urine samples, which can be self-collected at home. This approach could offer a more acceptable and practical alternative to traditional invasive methods like cervical, blood, or vaginal samples. The study aims to reduce variability in urine samples to make this method suitable for vaccine research. The study includes 150 participants divided into six groups: pre-adolescent girls, women using different types of contraceptives or none, post-menopausal women, and men, all vaccinated against HPV. Over 36 days, participants will self-collect between 6 and 21 first-void urine samples using a device called Colli-Pee. They will also visit the study site twice for blood samples on day 1 and day 36. The samples will be analyzed to study antibody levels, menstrual cycle effects, and HPV DNA presence. Participants will be monitored through their self-collected urine samples and blood tests. The research team will examine fluctuations in HPV-specific antibodies and test for other biomarkers to better understand variability. The main outcome measured is the concentration of total and HPV-specific IgG antibodies in the urine within six months after study completion. Secondary outcomes include antibody levels in blood and HPV DNA status. The study supports long-term monitoring of immune responses with non-invasive sampling methods.
CONDITIONS
Brief Title
Normalizing Antibody Detection in First-void Urine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Vaccinated with Cervarix, Gardasil, or Gardasil9 HPV vaccine and able to provide official vaccination proof.
- Able to understand the study information.
- Willing to give informed consent to contact their general practitioner or gynecologist for vaccination details and cervical cancer screening results (if applicable).
You will not qualify if you...
- Participating in another clinical trial at the same time.
- Women who had a hysterectomy or treatment for cervical (pre)cancer lesions within the last six months.
- Pregnant women.
- Positive for HIV, Hepatitis B, or Hepatitis C.
- Having any condition that might affect study results or participant safety, as judged by the investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility confirmation and informed consent
Duration - 36 days
Participants self-collect first-void urine samples at home over 36 days and attend two scheduled study site visits for blood collection.
6 to 21 self-collections of first-void urine samples at home depending on cohort; 2 in-person visits at study site (Day 1 and Day 36) including blood collection
Trial Site Locations
Total: 1 location
1
University of Antwerp
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
Research Team
A
Alex Vorsters, Professor
M
Margo Bell
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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