Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study)

Human Papilloma Virus Infection Clinical Trial

— AB-SOP  

Official title:

Collection of First-void Urine Samples for the Development of Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine: the AB-SOP Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714114
• Other study ID #: B300201525584
• Status: Completed
• Phase: N/A
• First received: March 10, 2016
• Last updated: June 14, 2017
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2017
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and antibody assays to monitor natural and/or vaccine induced immunity against HPV (Human Papillomavirus).

Description:

In total 57 women will be included in this trial: 38 vaccinated with an prophylactic HPV vaccine and 19 not vaccinated with a prophylactic HPV vaccine. These women are asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc is collected. The collected urine and blood samples will be used for the development and optimisation of robust analytical protocols for sample preparation and antibody assays.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

• Female

• 18-26 year

• Cases (n=38): healthy women, fully vaccinated, i.e. receiving all three doses of the bivalent (Cervarix®) or quadrivalent (Gardasil®) HPV vaccine (according to the KCE (Belgian Knowledge Centre for Health) recommendations: age at first vaccination between 10-25 years for the bivalent and 9-26 years for the quadrivalent vaccine).

• Cases should be able to prove their vaccination (brand and schedule) with an official document.

• Control group (n=19): healthy women, self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available (Gardasil®, Cervarix®, Gardasil-9®)

• Signing informed consent form (ICF).

• 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:

• Participating in another clinical study at the same time of participating in this study.

• Not able to understand the information brochure/what the study is about

• Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

Related Conditions & MeSH terms

• Human Papilloma Virus Infection
• Papilloma
• Papillomavirus Infections
• Virus Diseases

Intervention

Other:
• First-void urine collection
One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).
• Blood draw
One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccinations (CEV).

Locations

Country	Name	City	State
Belgium	Pierre Van Damme	Wilrijk	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples	To detect HPV specific IgG concentrations (ratio HPV specific IgG/total human IgG), in paired first-void urine and serum samples from 57 women to monitor the immune response after vaccination with a prophylactic HPV vaccine (Gardasil or Cervarix).	Within 6 months after study completion
Secondary	Concentration HPV specific IgA (Immunoglobulin A) in paired first-void urine and serum samples	To detect HPV specific IgA concentrations (ratio HPV specific IgA/total human IgA), in paired first-void urine and serum samples from 57 women to monitor the immune response after vaccination with a prophylactic HPV vaccine (Gardasil or Cervarix).	Within 6 months after study completion