Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine
- Conditions
- Human Papilloma Virus Infection
- Registration Number
- NCT03542227
- Lead Sponsor
- Universiteit Antwerpen
- Brief Summary
The aim of the study is to develop and implement robust analytical protocols for first-void urine sample preparation and antibody assays to monitor vaccine induced immunity against HPV (Human Papillomavirus).
- Detailed Description
Participants of the HPV V503-004 study (Phase III Clinical trial vaccinating (young) adult women in Antwerp, EudraCT NUMBER: 2015-005093-38) will be asked if they are willing to provide two additional urine samples at day 1 and month 7 for biomedical research. Furthermore, they will be contacted again at approximately 3.5 years and asked if they are willing to provide an additional urine sample and a serum sample. At 3.5 years, they will also be asked to fill in a brief questionnaire. The collected urine will be used for the development and optimization of robust analytical protocols for sample preparation and antibody assays.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 63
- Participant of the HPV V503-004 study at UA/UZA
- Willing to give informed consent (ICF) to the CEV research team
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concentration of HPV specific IgG (Immunoglobulin G) in FV urine. Within 6 months after study completion To detect HPV specific IgG concentrations (ratio HPV specific IgG/total human IgG), in first-void urine from 63 women to monitor the immune response before and after vaccination with a prophylactic HPV vaccine (Gardasil9).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
university of Antwerp - centre for the evaluation of vaccination
🇧🇪Wilrijk, Antwerp, Belgium