Normalizing Antibody Detection in First-void Urine

NCT06582654 | Recruiting

• 1 other identifier: B3002023000105
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus Infection

Keywords

Antibodies; Vaccination; Self-sampling; First-void urine

Outcome Measures

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.

  Within six months after completion of the study

Secondary Outcomes (3)

• Concentration of total and HPV-specific IgG (immunoglobulin G) in serum.

  Within six months after completion of the study

• HPV DNA status of first-void urine samples.

  Within six months after completion of the study

• Other biomarkers/analyses.

  Within six months after completion of the study

Study Arms (6)

Pre-adolescent group

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

Ovulatory group

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

Ovulation-influencing contraceptive group

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

Non-ovulation-influencing contraceptive group

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

Post-menopausal group

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

Male group

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

Interventions

Sampling DEVICE

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).

Male group; Non-ovulation-influencing contraceptive group; Ovulation-influencing contraceptive group; Ovulatory group; Post-menopausal group; Pre-adolescent group

Eligibility Criteria

• Age: 9 Years - 70 Years
• Gender Eligibility Details: All groups are female, except for one male group (aged 18-30 years old)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

University of Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

First-void urine samples Serum samples

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wiebren Tjalma, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Vorsters, Professor

CONTACT

+3232659130; alex.vorsters@uantwerpen.be

Margo Bell

CONTACT

+32476014843; margo.bell@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Gynecological Oncologist

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: December 7, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)