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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03542227

Acronym

ABSOP-FollowUp

Enrollment

Registered

2018-05-31

Start date

2017-12-11

Completion date

2022-06-23

Last updated

2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus Infection

Keywords

Antibodies, Vaccination, Self-sampling, First-void urine, HPV

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).

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.

Interventions

OTHERFirst-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.

OTHERBlood draw

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026