Study for the Development of Standard Operating Procedures for Anti-HPV Antibody Detection in First-void Urine: the AB-SOP Follow-up Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Human Papilloma Virus Infection
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Concentration of HPV specific IgG (Immunoglobulin G) in FV urine.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Pierre Van Damme
Principal investigator
Universiteit Antwerpen
Eligibility Criteria
Inclusion Criteria
- •Participant of the HPV V503-004 study at UA/UZA
- •Willing to give informed consent (ICF) to the CEV research team
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Concentration of HPV specific IgG (Immunoglobulin G) in FV urine.
Time Frame: 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).