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

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).

Full Title of Study: “Collection of First-void Urine Samples for the Development of Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine: the AB-SOP Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2015

Detailed Description

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.

Interventions

  • Other: First-void urine collection
    • 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).
  • Other: Blood draw
    • One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccinations (CEV).

Arms, Groups and Cohorts

  • Cases: HPV vaccinated group
    • Women (18-26 years old) whom are previously vaccinated with the bivalent (Cervarix) or quadrivalent (Gardasil) prophylactic HPV vaccine. No clinical evaluations will be performed.
  • Controls: HPV unvaccinated group
    • Women (18-26 years old) whom are not vaccinated with the bivalent (Cervarix) or quadrivalent (Gardasil) prophylactic HPV vaccine. No clinical evaluations will be performed.

Clinical Trial Outcome Measures

Primary Measures

  • Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples
    • Time Frame: Within 6 months after study completion
    • 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).

Secondary Measures

  • Concentration HPV specific IgA (Immunoglobulin A) in paired first-void urine and serum samples
    • Time Frame: Within 6 months after study completion
    • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 26 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universiteit Antwerpen
  • Collaborator
    • Research Foundation Flanders
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pierre Van Damme, Professor Pierre Van Damme, MD, PhD – Universiteit Antwerpen
  • Overall Official(s)
    • Pierre Van Damme, Prof MD PhD, Principal Investigator, Universiteit Antwerpen

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