An observational study in Human Papillomavirus Infection, sponsored by Universiteit Antwerpen. Recruiting at 1 site in Belgium. Open to participants aged 9 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by Universiteit Antwerpen · Observational
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.
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.
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's planned enrollment of 150 is below the median of 400 across 147 observational studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Universiteit Antwerpen is the lead sponsor of 128 studies on the registry; 28 are open to participants now.
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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).
Exclusion Criteria:
Defined as girls between 9 and 14 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are not yet menstruating (pre-menarche).
Device: Sampling
Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are not using any hormone- or ovulation-influencing contraceptives that impact hormonal levels during the menstrual cycle.
Device: Sampling
Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are using ovulation-influencing contraceptives that impact hormonal levels during the menstrual cycle (including oral contraceptives, hormonal ring, contraceptive injection, contraceptive patch, hormonal implant).
Device: Sampling
Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are using contraceptives that do not affect ovulation (i.e. intrauterine devices).
Device: Sampling
Defined as fully vaccinated women between 50 and 70 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and have had no menses for at least one year.
Device: Sampling
Defined as fully vaccinated men between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine.
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).
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 study
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 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.
Time frame: 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.
Time frame: Within six months after completion of the study
Plan to share: No
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Universiteit Antwerpen