Human Papilloma Virus Infection
Conditions
Keywords
First-void urine, Self-sampling, Vaccination, Infectious virions, Neutralizing antibodies, HPV
Brief summary
The main objective of this study is to develop protocols using FV urine that investigate in vitro whether infectious virions can be neutralized by HPV vaccination.
Detailed description
In total 50 women will be included in this trial whereof 25 fully vaccinated with a prophylactic HPV vaccine and 25 not vaccinated with a prophylactic HPV vaccine. These women will be asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc will be collected. HPV DNA positive women who gave their consent to be contacted with the results, will later be contacted again and asked to provide additional FV urine samples every day during 2 weeks. For this, urine collection devices (Colli-PeeTM, Novosanis) will be provided by postal mail. The collected urine samples (and blood sample as control for HPV antibodies) will be used for the development of protocols within this project.
Interventions
* One time collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) during visit at the Centre for the Evaluation of Vaccination. * IF HPV positive and the woman gave consent to be contacted again: Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) each day during 14 days (n = 14)
OTHERBlood draw
\- One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.
Sponsors
Universiteit Antwerpen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * 18-25 years of age * Sexually active or has been sexually active in the past * Cases (n=25): fully vaccinated women, i.e. receiving all necessary doses of the HPV vaccine (according to the KCE recommendations) able to prove their vaccination (brand and schedule) with an official document. * Control group (n=25): women self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available. * Willing to give informed consent to the CEV research team. * 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
* Women participating in another clinical study at the same time of this study. * Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protocols to investigate the neutralizing ability of HPV vaccine-induced antibodies | Within 2 years after study completion | To develop protocols that investigate whether infectious HPV virions may be neutralized by HPV vaccine-induced antibodies, preventing autoinoculation and transmission to sexual partners. |
Countries
Belgium
Outcome results
None listed