Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples (HPV-VACPLUS)

Developing Methods to Investigate Additional Opportunities of HPV Vaccination, Including Control of Infection and Transmission, by Using a Cervicovaginal Human Sample, Collected by Urination (HPV-VACPLUS)

The main objective of this study is to develop protocols using FV urine that investigate in vitro whether infectious virions can be neutralized by HPV vaccination.

Study Overview

• Status: Completed
• Conditions: Human Papilloma Virus Infection
• Intervention / Treatment: Other: First-void urine collection; Other: Blood draw

Detailed Description

In total 50 women will be included in this trial whereof 25 fully vaccinated with a prophylactic HPV vaccine and 25 not vaccinated with a prophylactic HPV vaccine. These women will be asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc will be collected. HPV DNA positive women who gave their consent to be contacted with the results, will later be contacted again and asked to provide additional FV urine samples every day during 2 weeks. For this, urine collection devices (Colli-PeeTM, Novosanis) will be provided by postal mail. The collected urine samples (and blood sample as control for HPV antibodies) will be used for the development of protocols within this project.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Belgium
  • Wilrijk
    • Antwerp, Wilrijk, Belgium, 2610
      • Universiteit Antwerpen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 23 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

In total 50 women will be included in this trial. During their study visit, participants are asked to collect a first-void urine sample with the Colli-PeeTM device. Hereafter, a blood sample of 5-10 cc is collected. Following sample collection, women are asked to fill in a questionnaire. HPV positive women who gave their consent to be contacted with the results will later be again contacted and asked to provide additional FV urine samples every day during 2 weeks.

Since this is a unique pilot study, no specific data exist for sample size calculation. However, the sample size is estimated based on HPV prevalence results from a surveillance study in Belgium. From the 50 participating women (age 18-25), we expect 20% to be HPV DNA positive.Taking possible dropouts into account, this will lead to approximately 5 HPV infected women to provide samples during 14 days. Ultimately, we will obtain 120 samples to be used to develop the intended protocols.

Description

Inclusion Criteria:

• Female
• 18-25 years of age
• Sexually active or has been sexually active in the past
• Cases (n=25): fully vaccinated women, i.e. receiving all necessary doses of the HPV vaccine (according to the KCE recommendations) able to prove their vaccination (brand and schedule) with an official document.
• Control group (n=25): women self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available.
• Willing to give informed consent to the CEV research team.
• Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF)

Exclusion Criteria:

• Women participating in another clinical study at the same time of this study.
• Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HPV vaccinated group; Women (18-25 years old) whom are previously fully vaccinated with the bivalent (Cervarix), quadrivalent (Gardasil) or nonavalent (Gardasil) prophylactic HPV vaccine. No intervention/drug to be administered.	Other: First-void urine collection; One time 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.; IF HPV positive and the woman gave consent to be contacted again: Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) each day during 14 days (n = 14); Other Names: FV urine; Other: Blood draw; - One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.
HPV unvaccinated group; Women (18-25 years old) whom are not previously vaccinated with the bivalent (Cervarix), quadrivalent (Gardasil) or nonavalent (Gardasil) prophylactic HPV vaccine. No intervention/drug to be administered.	Other: First-void urine collection; One time 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.; IF HPV positive and the woman gave consent to be contacted again: Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) each day during 14 days (n = 14); Other Names: FV urine; Other: Blood draw; - One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protocols to investigate the neutralizing ability of HPV vaccine-induced antibodies	To develop protocols that investigate whether infectious HPV virions may be neutralized by HPV vaccine-induced antibodies, preventing autoinoculation and transmission to sexual partners.	Within 2 years after study completion

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Investigators: Principal Investigator: Pierre Van Damme, Prof, MD, PhD, Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Vaccination; First-void urine; HPV; Self-sampling; Infectious virions; Neutralizing antibodies
• Additional Relevant MeSH Terms: Virus Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; DNA Virus Infections; Tumor Virus Infections; Neoplasms, Squamous Cell; Infections; Papillomavirus Infections; Papilloma
• Other Study ID Numbers: B3002020000025

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