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

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).

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Key information

Conditions

Human Papilloma Virus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

16 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

university of Antwerp - centre for the evaluation of vaccination

Wilrijk, Antwerp, 2610, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participant of the HPV V503-004 study at UA/UZA
Willing to give informed consent (ICF) to the CEV research team

Treatment and study plan

First-void urine collection

Other

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 names: FV urine

Blood Draw

Other

Blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.

Other names: Serum sample

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).

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Official study title

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

Acronym: ABSOP-FollowUp

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: May 31, 2018
Registry last updated: Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed