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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Human Papilloma Virus Infection

Intervention / Treatment
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* Other: First-void urine collection
* Other: Blood draw


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HPV vaccinated group<br>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<br>* 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)<br>* Other names: FV urine;Other: Blood draw<br>* - One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.<br>|
| HPV unvaccinated group<br>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<br>* 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)<br>* Other names: FV urine;Other: Blood draw<br>* - One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, First-void urine, Self-sampling, Vaccination, Infectious virions, Neutralizing antibodies