Clinical trial NCT06582654: Normalizing Antibody Detection in First-void Urine
Official title: URINORM: Normalizing Antibody Detection in First-void Urine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Papillomavirus Infection
Keywords: Antibodies
Vaccination
Self-sampling
First-void urine
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2024-09-03
Enrollment: 150
Sex: ALL
Minimum age (years): 9
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Concentration of total and HPV-specific IgG (immunoglobulin G) in first-void urine.
timeFrame: Within six months after completion of the study
Secondary outcomes:
measure: Concentration of total and HPV-specific IgG (immunoglobulin G) in serum.
timeFrame: Within six months after completion of the study
measure: HPV DNA status of first-void urine samples.
timeFrame: Within six months after completion of the study
measure: Other biomarkers/analyses.
timeFrame: Within six months after completion of the study
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University of Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Wiebren Tjalma, MD
role: PRINCIPAL_INVESTIGATOR
References: