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NCT03542227 Clinical Trial

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

Human Papilloma Virus Infection Clinical Trial

— ABSOP-FollowUp  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03542227
Other study ID # B300201734258
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 11, 2017
Est. completion date June 23, 2022

Study information
Verified date November 2022
Source Universiteit Antwerpen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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 information / eligibility
Status Completed
Enrollment 63
Est. completion date June 23, 2022
Est. primary completion date January 11, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 55 Years
Eligibility Inclusion Criteria: - Participant of the HPV V503-004 study at UA/UZA - Willing to give informed consent (ICF) to the CEV research team

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium university of Antwerp - centre for the evaluation of vaccination Wilrijk Antwerp

Sponsors (1)
Lead Sponsor Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of HPV specific IgG (Immunoglobulin G) in FV urine. 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). Within 6 months after study completion
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