Status:
COMPLETED
Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples
Lead Sponsor:
Universiteit Antwerpen
Conditions:
Human Papilloma Virus Infection
Eligibility:
FEMALE
18-25 years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04391647
Start Date
May 11 2020
End Date
July 1 2020
Last Update
September 29 2021
Active Locations (1)
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1
Universiteit Antwerpen
Antwerp, Wilrijk, Belgium, 2610