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

Study Overview
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Brief Summary
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The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and antibody assays to monitor natural and/or vaccine induced immunity against HPV (Human Papillomavirus).

Detailed Description
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In total 57 women will be included in this trial: 38 vaccinated with an prophylactic HPV vaccine and 19 not vaccinated with a prophylactic HPV vaccine. These women are asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc is collected. The collected urine and blood samples will be used for the development and optimisation of robust analytical protocols for sample preparation and antibody assays.

Official Title
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Collection of First-void Urine Samples for the Development of Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine: the AB-SOP Study

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 18-26 year Cases (n=38): healthy women, fully vaccinated, i.e. receiving all three doses of the bivalent (Cervarix®) or quadrivalent (Gardasil®) HPV vaccine (according to the KCE (Belgian Knowledge Centre for Health) recommendations: age at first vaccination between 10-25 years for the bivalent and 9-26 years for the quadrivalent vaccine). Cases should be able to prove their vaccination (brand and schedule) with an official document. Control group (n=19): healthy women, self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available (Gardasil®, Cervarix®, Gardasil-9®) Signing informed consent form (ICF). 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: Participating in another clinical study at the same time of participating in this study. Not able to understand the information brochure/what the study is about Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 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 |
| --- | --- |
| Cases: HPV vaccinated group<br>Women (18-26 years old) whom are previously vaccinated with the bivalent (Cervarix) or quadrivalent (Gardasil) prophylactic HPV vaccine. No clinical evaluations will be performed. | Other: First-void urine collection<br>* One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).<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 Vaccinations (CEV).<br>* Other names: Blood;|
| Controls: HPV unvaccinated group<br>Women (18-26 years old) whom are not vaccinated with the bivalent (Cervarix) or quadrivalent (Gardasil) prophylactic HPV vaccine. No clinical evaluations will be performed. | Other: First-void urine collection<br>* One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).<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 Vaccinations (CEV).<br>* Other names: Blood;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples | To detect HPV specific IgG concentrations (ratio HPV specific IgG/total human IgG), in paired first-void urine and serum samples from 57 women to monitor the immune response after vaccination with a prophylactic HPV vaccine (Gardasil or Cervarix). | Within 6 months after study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration HPV specific IgA (Immunoglobulin A) in paired first-void urine and serum samples | To detect HPV specific IgA concentrations (ratio HPV specific IgA/total human IgA), in paired first-void urine and serum samples from 57 women to monitor the immune response after vaccination with a prophylactic HPV vaccine (Gardasil or Cervarix). | Within 6 months after study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibodies, Vaccination, Self-sampling, First-void urine, Serum