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

Sponsor

Universiteit Antwerpen (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03542227

Collaborator

(none)

Enrollment

Location

55.1

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Human Papilloma Virus Infection	Other: First-void urine collection Other: Blood draw

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.

Study Design

Study Type:

Observational

Actual Enrollment :

63 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 11, 2017

Actual Primary Completion Date :

Jan 11, 2022

Anticipated Study Completion Date :

Jul 15, 2022

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	university of Antwerp - centre for the evaluation of vaccination	Wilrijk	Antwerp	Belgium	2610

Sponsors and Collaborators

Universiteit Antwerpen

Investigators

Principal Investigator: Pierre Van Damme, Prof, MD, PhD, Universiteit Antwerpen
Principal Investigator: Ilse De Coster, MD, Universiteit Antwerpen
Principal Investigator: Wiebren A. A. Tjalma, Prof, MD, PhD, University Hospital, Antwerp