Normalizing Antibody Detection in First-void Urine (URINORM)

URINORM: Normalizing Antibody Detection in First-void Urine

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.

Study Overview

• Status: Recruiting
• Conditions: Human Papillomavirus Infection

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Alex Vorsters, Professor; Phone Number: +3232659130; Email: alex.vorsters@uantwerpen.be
• Study Contact Backup: Name: Margo Bell; Phone Number: +32476014843; Email: margo.bell@uantwerpen.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of total and HPV-specific IgG (immunoglobulin G) in first-void urine.	To follow-up levels of total and HPV-specific antibodies in first-void urine at repeated measurements and compare levels of total and HPV-specific antibodies in first-void urine between young men, pre-adolescent girls, post-menopausal women, and women on a contraceptive or ovulatory cycle.	Within six months after completion of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of total and HPV-specific IgG (immunoglobulin G) in serum.	To compare levels of total and HPV-specific antibodies in serum at repeated measurements and look into correlation between total and HPV-specific antibodies in serum and first-void urine.	Within six months after completion of the study
HPV DNA status of first-void urine samples.	To test for the presence of HPV DNA in first-void urine samples from different cohorts of men, girls and women vaccinated against HPV.	Within six months after completion of the study
Other biomarkers/analyses.	To test various biomarkers (e.g. total IgG, IgG subclasses, total protein, total human DNA…) in first-void urine samples from different cohorts of men, girls and women vaccinated against HPV and perform other relevant analyses within the scope of the study. To test various biomarkers (e.g. total IgG, IgG subclasses, total protein, total human DNA…) in first-void urine samples from different cohorts of men, girls and women vaccinated against HPV and perform other relevant analyses within the scope of the study.	Within six months after completion of the study

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Vaccination; First-void urine; Antibodies; Self-sampling
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Papillomavirus Infections
• Other Study ID Numbers: B3002023000105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No