Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples
Condition: Human Papilloma Virus Infection
MeSH terms: Infections; Papillomavirus Infections; Papilloma
Study type: Observational

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.
    

Intervention name(s): First-void urine collection; Blood draw
Intervention type(s): Other; Other
Intervention description(s): 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); - One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.
Other intervention name(s): FV urine
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.
      
Biospecimen description: 
      First-void urine samples and Serum samples
    
Keywords: First-void urine; Self-sampling; Vaccination; Infectious virions; Neutralizing antibodies; HPV