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

NCT02714114 | Completed

• 1 other identifier: B300201525584
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Human Papilloma Virus Infection

Keywords

Antibodies; Vaccination; Self-sampling; First-void urine; Serum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Concentration HPV specific IgA (Immunoglobulin A) in paired first-void urine and serum samples

  Within 6 months after study completion

Study Arms (2)

Cases: HPV vaccinated group

Women (18-26 years old) whom are previously vaccinated with the bivalent (Cervarix) or quadrivalent (Gardasil) prophylactic HPV vaccine. No clinical evaluations will be performed.

Other: First-void urine collection; Other: Blood draw

Controls: HPV unvaccinated group

Women (18-26 years old) whom are not vaccinated with the bivalent (Cervarix) or quadrivalent (Gardasil) prophylactic HPV vaccine. No clinical evaluations will be performed.

Other: First-void urine collection; Other: Blood draw

Interventions

First-void urine collection OTHER

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).

Also known as: FV urine

Cases: HPV vaccinated group; Controls: HPV unvaccinated group

Blood draw OTHER

One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccinations (CEV).

Also known as: Blood

Cases: HPV vaccinated group; Controls: HPV unvaccinated group

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

In total 57 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. For this pilot study, our study population is based on unequal groups with twice as many cases (vaccinated women) then controls (non-vaccinated women) (k = 2) because our focus is to develop analytical protocols and assays for anti HPV antibodies. This results in a total sample size of 57, including 19 controls (non-vaccinated women) and 38 cases (vaccinated women).

You may qualify if:

• Female
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

Pierre Van Damme

Wilrijk, Antwerp, 2610, Belgium

Location

Related Publications (1)

• Van Keer S, Willhauck-Fleckenstein M, Pattyn J, Butt J, Tjalma WAA, Van Ostade X, Hens N, Van Damme P, Waterboer T, Vorsters A. First-void urine as a non-invasive liquid biopsy source to detect vaccine-induced human papillomavirus antibodies originating from cervicovaginal secretions. J Clin Virol. 2019 Aug;117:11-18. doi: 10.1016/j.jcv.2019.05.004. Epub 2019 May 11.

  PMID: 31129514 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

First-void urine samples and Blood samples

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pierre Van Damme, Prof MD PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Pierre Van Damme, MD, PhD

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 21, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)