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

Universiteit Antwerpen

Status: Completed

Conditions: Human Papilloma Virus Infection

Treatments: Other: Blood draw; Other: First-void urine collection

Study type: Observational

Funder types: Other

Identifiers

NCT04391647

B3002020000025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

HPV vaccinated group

Description:

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.

Treatment:

Other: Blood draw

Other: First-void urine collection

HPV unvaccinated group

Description:

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.

Treatment:

Other: Blood draw

Other: First-void urine collection