Clinical trial NCT02714114: Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papilloma Virus Infection
Keywords: Antibodies
Vaccination
Self-sampling
First-void urine
Serum
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2016-03-21
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples
timeFrame: Within 6 months after study completion
Secondary outcomes:
measure: Concentration HPV specific IgA (Immunoglobulin A) in paired first-void urine and serum samples
timeFrame: Within 6 months after study completion
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: Pierre Van Damme
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Pierre Van Damme, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Keer S, Willhauck-Fleckenstein M, Pattyn J, Butt J, Tjalma WAA, Van Ostade X, Hens N, Van Damme P, Waterboer T, Vorsters A. First-void urine as a non-invasive liquid biopsy source to detect vaccine-induced human papillomavirus antibodies originating from cervicovaginal secretions. J Clin Virol. 2019 Aug;117:11-18. doi: 10.1016/j.jcv.2019.05.004. Epub 2019 May 11.