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

Completed

• Conditions: Human Papilloma Virus Infection

• Registration Number: NCT02714114
• Lead Sponsor: Universiteit Antwerpen

Brief Summary

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).

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.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-21
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples	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 Outcome Measures

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

Trial Locations

Locations (1)

Pierre Van Damme; 🇧🇪 Wilrijk, Antwerp, Belgium