Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples

NCT ID: NCT04391647

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2020-07-01

Brief Summary

The main objective of this study is to develop protocols using FV urine that investigate in vitro whether infectious virions can be neutralized by HPV vaccination.

Detailed Description

In total 50 women will be included in this trial whereof 25 fully vaccinated with a prophylactic HPV vaccine and 25 not vaccinated with a prophylactic HPV vaccine. These women will be asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc will be collected. HPV DNA positive women who gave their consent to be contacted with the results, will later be contacted again and asked to provide additional FV urine samples every day during 2 weeks. For this, urine collection devices (Colli-PeeTM, Novosanis) will be provided by postal mail. The collected urine samples (and blood sample as control for HPV antibodies) will be used for the development of protocols within this project.

Conditions

Human Papilloma Virus Infection

Study Design

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

Study Groups

HPV vaccinated group

Women (18-25 years old) whom are previously fully vaccinated with the bivalent (Cervarix), quadrivalent (Gardasil) or nonavalent (Gardasil) prophylactic HPV vaccine.

No intervention/drug to be administered.

First-void urine collection

Intervention Type: OTHER

• One time collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) during visit at the Centre for the Evaluation of Vaccination.
• IF HPV positive and the woman gave consent to be contacted again: Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) each day during 14 days (n = 14)

Blood draw

Intervention Type: OTHER

\- One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.

HPV unvaccinated group

Women (18-25 years old) whom are not previously vaccinated with the bivalent (Cervarix), quadrivalent (Gardasil) or nonavalent (Gardasil) prophylactic HPV vaccine.

No intervention/drug to be administered.

First-void urine collection

Intervention Type: OTHER

• One time collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) during visit at the Centre for the Evaluation of Vaccination.
• IF HPV positive and the woman gave consent to be contacted again: Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) each day during 14 days (n = 14)

Blood draw

Intervention Type: OTHER

\- One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.

Interventions

First-void urine collection

• One time collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) during visit at the Centre for the Evaluation of Vaccination.
• IF HPV positive and the woman gave consent to be contacted again: Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) each day during 14 days (n = 14)

Intervention Type: OTHER

Blood draw

\- One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.

Intervention Type: OTHER

Other Intervention Names

FV urine

Eligibility Criteria

Inclusion Criteria

• Female
• 18-25 years of age
• Sexually active or has been sexually active in the past
• Cases (n=25): fully vaccinated women, i.e. receiving all necessary doses of the HPV vaccine (according to the KCE recommendations) able to prove their vaccination (brand and schedule) with an official document.
• Control group (n=25): women self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available.
• Willing to give informed consent to the CEV research team.
• Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF)

Exclusion Criteria

• Women participating in another clinical study at the same time of this study.
• Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Pierre Van Damme

Professor Pierre Van Damme, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierre Van Damme, Prof, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

Universiteit Antwerpen

Antwerp, Wilrijk, Belgium

Countries

Belgium

Other Identifiers

B3002020000025

Identifier Type: -

Identifier Source: org_study_id