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

NCT03542227 | Completed

• 1 other identifier: B300201734258
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

Human Papilloma Virus Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

First-void urine collection OTHER

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.

Also known as: FV urine

Blood draw OTHER

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

Also known as: Serum sample

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

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

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

university of Antwerp - centre for the evaluation of vaccination

Wilrijk, Antwerp, 2610, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

First-void urine samples (3) and serum samples (1)

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: May 31, 2018
• Study Start: December 11, 2017
• Primary Completion: January 11, 2022
• Study Completion: June 23, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)