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

Universiteit Antwerpen

Status: Completed

Conditions: Human Papilloma Virus Infection

Treatments: Other: Blood draw; Other: First-void urine collection

Study type: Observational

Funder types: Other

Identifiers

NCT02714114

B300201525584

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 57 patients

Sex: Female

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

57 participants in 2 patient groups

Cases: HPV vaccinated group

Description:

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.

Treatment:

Other: First-void urine collection

Other: Blood draw

Controls: HPV unvaccinated group

Description:

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.

Treatment:

Other: First-void urine collection

Other: Blood draw