Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study)

Universiteit Antwerpen57 enrolled

Overview

The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and antibody assays to monitor natural and/or vaccine induced immunity against HPV (Human Papillomavirus).

In total 57 women will be included in this trial: 38 vaccinated with an prophylactic HPV vaccine and 19 not vaccinated with a prophylactic HPV vaccine. These women are asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc is collected. The collected urine and blood samples will be used for the development and optimisation of robust analytical protocols for sample preparation and antibody assays.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Human Papilloma Virus Infection

Interventions

First-void urine collectionOTHER

One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).

Blood drawOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 26 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female * 18-26 year * Cases (n=38): healthy women, fully vaccinated, i.e. receiving all three doses of the bivalent (Cervarix®) or quadrivalent (Gardasil®) HPV vaccine (according to the KCE (Belgian Knowledge Centre for Health) recommendations: age at first vaccination between 10-25 years for the bivalent and 9-26 years for the quadrivalent vaccine). * Cases should be able to prove their vaccination (brand and schedule) with an official document. * Control group (n=19): healthy women, self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available (Gardasil®, Cervarix®, Gardasil-9®) * Signing informed consent form (ICF). * 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: * Participating in another clinical study at the same time of participating in this study. * Not able to understand the information brochure/what the study is about * Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

Locations (1)

Pierre Van Damme

Wilrijk, Antwerp, Belgium

Outcomes

Primary Outcomes

Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples

To detect HPV specific IgG concentrations (ratio HPV specific IgG/total human IgG), in paired first-void urine and serum samples from 57 women to monitor the immune response after vaccination with a prophylactic HPV vaccine (Gardasil or Cervarix).

Time frame: Within 6 months after study completion

Secondary Outcomes

Concentration HPV specific IgA (Immunoglobulin A) in paired first-void urine and serum samples

To detect HPV specific IgA concentrations (ratio HPV specific IgA/total human IgA), in paired first-void urine and serum samples from 57 women to monitor the immune response after vaccination with a prophylactic HPV vaccine (Gardasil or Cervarix).

Time frame: Within 6 months after study completion

Data from ClinicalTrials.gov

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