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

November 7, 2022 updated by: Pierre Van Damme, Universiteit Antwerpen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Wilrijk, Antwerp, Belgium, 2610
        • University of Antwerp - Centre for the Evaluation of Vaccination

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

In total 63 women are included in this trial. During their first two study visits, at day 0 and 7m post-vaccination, participants are asked to collect a first-void urine sample with the Colli-PeeTM device (n=63). During their third visit, the included women are asked to collect a third first-void urine sample with the Colli-PeeTM device (n = 58). Hereafter, a blood sample of 5-10 cc is collected. Following sample collection, women are asked to fill in a questionnaire (n=58).

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 6 months after study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2017

Primary Completion (Actual)

January 11, 2022

Study Completion (Actual)

June 23, 2022

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

May 18, 2018

First Posted (Actual)

May 31, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B300201734258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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