NCT06582654

Normalizing Antibody Detection in First-void Urine

URINORM: Normalizing Antibody Detection in First-void Urine

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: All
• Age: 9 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus (HPV) in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts.

Detailed description

To date, invasive clinician-collected cervical samples, blood, and vaginal samples are still the primary methods to monitor disease and immune responses to vaccine-preventable genital tract infections. Replacing these samples with a specimen that is non-invasive and can be self-collected at home could have important acceptance and feasibility advantages and could facilitate the logistics of clinical trials and future epidemiological studies. Initial results of experiments using first-void urine samples for immune response monitoring are promising. However, overall standardization and normalization of fluctuation in signals are necessary for it to become a suitable genital tract liquid biopsy in vaccine research. Therefore, the aim of this study is to normalize antibody detection in first-void urine by reducing sample variability, using the human papillomavirus (HPV) as a model. A total of 150 participants will be included, consisting of six different cohorts, including a group of pre-adolescent girls (n=25), a group of young women using ovulation-influencing contraceptives (n=25), a group of young women using non-ovulation-influencing contraceptives (n=25), a group of young women using no contraceptives (n=25), a group of post-menopausal women (n=25), and a group of men (n=25). Participants will be followed over a period of 36 days, and will be asked to self-collect 6 to 21 first-void urine samples (depending on cohort) using a Colli-Pee 20mL (Novosanis). Moreover, participants will have two scheduled visits (day 1 and 36 of the study) at the study site, where each time a blood collection (1x 5-10cc) will be performed. Collected first-void urine and serum samples will be analyzed for menstrual cycle-related fluctuations and between-group differences in HPV-specific antibody levels. Moreover, to compare immunological with viral endpoints, HPV DNA detection and genotyping will be performed on the first-void urine sample and samples will be tested for various biomarkers that might be valuable for the normalization of inter- and intra-individual variability.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
DEVICE	Sampling	Collection of first-void urine (i.e. the initial stream of the urine) with the Colli-Pee device (Novosanis, Belgium) (6-21 samples over a period of 36 days). Collection of blood samples (2 samples, at day 1 and 36 of the study).

Timeline

• Start date: 2023-12-07
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-09-03
• Last updated: 2024-09-03

Locations

1 site across 1 country: Belgium