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

Universiteit Antwerpen50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Human Papilloma Virus Infection

Interventions

First-void urine collectionOTHER

* 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 drawOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Universiteit Antwerpen

Antwerp, Wilrijk, Belgium

Outcomes

Primary Outcomes

Protocols to investigate the neutralizing ability of HPV vaccine-induced antibodies

To develop protocols that investigate whether infectious HPV virions may be neutralized by HPV vaccine-induced antibodies, preventing autoinoculation and transmission to sexual partners.

Time frame: Within 2 years after study completion

Data from ClinicalTrials.gov

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