Human Papilloma Virus Infection
Conditions
Keywords
Antibodies, Vaccination, Self-sampling, First-void urine, Serum
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.
Interventions
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).
OTHERBlood draw
One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccinations (CEV).
Sponsors
Research Foundation Flanders
Universiteit Antwerpen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 26 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples | Within 6 months after study completion | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration HPV specific IgA (Immunoglobulin A) in paired first-void urine and serum samples | Within 6 months after study completion | 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). |
Countries
Belgium
Outcome results
None listed