Clinical trial NCT04391647: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papilloma Virus Infection
Keywords: First-void urine
Self-sampling
Vaccination
Infectious virions
Neutralizing antibodies
HPV
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In total 50 women will be included in this trial. During their study visit, participants are asked to collect a first-void urine sample with the Colli-PeeTM device. Hereafter, a blood sample of 5-10 cc is collected. Following sample collection, women are asked to fill in a questionnaire. HPV positive women who gave their consent to be contacted with the results will later be again contacted and asked to provide additional FV urine samples every day during 2 weeks.

Since this is a unique pilot study, no specific data exist for sample size calculation. However, the sample size is estimated based on HPV prevalence results from a surveillance study in Belgium. From the 50 participating women (age 18-25), we expect 20% to be HPV DNA positive.Taking possible dropouts into account, this will lead to approximately 5 HPV infected women to provide samples during 14 days. Ultimately, we will obtain 120 samples to be used to develop the intended protocols.

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 criteria: 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.

Primary outcomes:
measure: Protocols to investigate the neutralizing ability of HPV vaccine-induced antibodies
timeFrame: Within 2 years after study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Universiteit Antwerpen
state: Wilrijk
Study officials:
affiliation: Universiteit Antwerpen
name: Pierre Van Damme, Prof, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: