Normalizing Antibody Detection in First-void Urine
ConditionHuman Papillomavirus Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-70
SponsorUniversiteit Antwerpen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sampling
DeviceCollection 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).
Treatment groups
150 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Pre-adolescent group1 intervention
Group B: Ovulatory group1 intervention
Group C: Ovulation-influencing contraceptive group1 intervention
Group D: Non-ovulation-influencing contraceptive group1 intervention
Group E: Post-menopausal group1 intervention
Group F: Male group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within six months after completion of the studySecondary outcomes
1
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.
Time frame
Within six months after completion of the study2
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.
Time frame
Within six months after completion of the study3
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.
Time frame
Within six months after completion of the studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Universiteit Antwerpen
Lead sponsor
University Hospital, Antwerp
Collaborator
Source ClinicalTrials.gov