NCT03542227

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

Study for the Development of Standard Operating Procedures for Anti-HPV Antibody Detection in First-void Urine: the AB-SOP Follow-up Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: Female
• Age: 16 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Papilloma Virus Infection

Interventions

Type	Name	Description
OTHER	First-void urine collection	Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) during visit at the Centre for the Evaluation of Vaccination.
OTHER	Blood draw	Blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.

Timeline

• Start date: 2017-12-11
• Primary completion: 2022-01-11
• Completion: 2022-06-23
• First posted: 2018-05-31
• Last updated: 2022-11-08

Locations

1 site across 1 country: Belgium