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

NCT04391647 | Completed

• 1 other identifier: B3002020000025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papilloma Virus Infection

Keywords

First-void urine; Self-sampling; Vaccination; Infectious virions; Neutralizing antibodies; HPV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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; Other: Blood draw

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; Other: Blood draw

Interventions

First-void urine collection OTHER

* 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)

Also known as: FV urine

HPV unvaccinated group; HPV vaccinated group

Blood draw OTHER

\- One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.

HPV unvaccinated group; HPV vaccinated group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Female
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

Universiteit Antwerpen

Antwerp, Wilrijk, 2610, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

First-void urine samples and Serum samples

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Pierre Van Damme, MD, PhD

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 18, 2020
• Study Start: May 11, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)