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Brief Title: Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples
Official Title: Developing Methods to Investigate Additional Opportunities of HPV Vaccination, Including Control of Infection and Transmission, by Using a Cervicovaginal Human Sample, Collected by Urination (HPV-VACPLUS)
Study ID: NCT04391647
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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Universiteit Antwerpen, Antwerp, Wilrijk, Belgium
Name: Pierre Van Damme, Prof, MD, PhD
Affiliation: Universiteit Antwerpen
Role: PRINCIPAL_INVESTIGATOR