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).

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.

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.

In total 57 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.

For this pilot study, our study population is based on unequal groups with twice as many cases (vaccinated women) then controls (non-vaccinated women) (k = 2) because our focus is to develop analytical protocols and assays for anti HPV antibodies. This results in a total sample size of 57, including 19 controls (non-vaccinated women) and 38 cases (vaccinated women).