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Spots Global Cancer Trial Database for Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Universiteit Antwerpen, Antwerp, Wilrijk, Belgium

Contact Details

Name: Pierre Van Damme, Prof, MD, PhD

Affiliation: Universiteit Antwerpen

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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