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

Completed

• Conditions: Human Papilloma Virus Infection
• Interventions: Other: First-void urine collection; Other: Blood draw

• 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

Arm && Interventions

Group	Intervention	Description
Cases: HPV vaccinated group	Blood draw	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.
Cases: HPV vaccinated group	First-void urine collection	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	Blood draw	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.
Controls: HPV unvaccinated group	First-void urine collection	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.

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