Normalizing Antibody Detection in First-void Urine

NCT ID: NCT06582654

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-07
• Study Completion Date: 2026-01-01

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.

Conditions

Human Papillomavirus Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Sampling

Intervention Type: 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).

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.

Sampling

Intervention Type: 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).

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).

Sampling

Intervention Type: 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).

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).

Sampling

Intervention Type: 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).

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.

Sampling

Intervention Type: 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

Defined as fully vaccinated men between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine.

Sampling

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Wiebren Tjalma

Professor and Gynecological Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wiebren Tjalma, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University of Antwerp

Edegem, Antwerp, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Alex Vorsters, Professor

Role: CONTACT

alex.vorsters@uantwerpen.be

+3232659130

Margo Bell

Role: CONTACT

margo.bell@uantwerpen.be

+32476014843

Facility Contacts

Alex Vorsters, Professor

Role: primary

alex.vorsters@uantwerpen.be

+3232659130

Margo Bell

Role: backup

margo.bell@uantwerpen.be

+32476014843

Other Identifiers

B3002023000105

Identifier Type: -

Identifier Source: org_study_id