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

NCT ID: NCT03542227

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-11

Study Completion Date

2022-06-23

Brief Summary

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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

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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

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Human Papilloma Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Blood draw

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

Intervention Type OTHER

Other Intervention Names

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FV urine Serum sample

Eligibility Criteria

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Inclusion Criteria

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

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Pierre Van Damme

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre Van Damme, Prof, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Ilse De Coster, MD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Wiebren A. A. Tjalma, Prof, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

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university of Antwerp - centre for the evaluation of vaccination

Wilrijk, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B300201734258

Identifier Type: -

Identifier Source: org_study_id

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