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Trial record 85 of 91 for:    cervarix

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

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ClinicalTrials.gov Identifier: NCT02714114
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : June 15, 2017
Sponsor:
Collaborator:
Research Foundation Flanders
Information provided by (Responsible Party):
Pierre Van Damme, Universiteit Antwerpen

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).

Condition or disease Intervention/treatment
Human Papilloma Virus Infection Other: First-void urine collection Other: Blood draw

Detailed 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.

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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).
Other Name: FV urine

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

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
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).
Other Name: FV urine

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




Primary Outcome Measures :
  1. Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples [ Time Frame: Within 6 months after study completion ]
    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).


Secondary Outcome Measures :
  1. Concentration HPV specific IgA (Immunoglobulin A) in paired first-void urine and serum samples [ Time Frame: Within 6 months after study completion ]
    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).


Biospecimen Retention:   Samples With DNA
First-void urine samples and Blood samples


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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714114


Locations
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Belgium
Pierre Van Damme
Wilrijk, Antwerp, Belgium, 2610
Sponsors and Collaborators
Universiteit Antwerpen
Research Foundation Flanders
Investigators
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Principal Investigator: Pierre Van Damme, Prof MD PhD Universiteit Antwerpen

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Responsible Party: Pierre Van Damme, Professor Pierre Van Damme, MD, PhD, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02714114     History of Changes
Other Study ID Numbers: B300201525584
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pierre Van Damme, Universiteit Antwerpen:
Antibodies
Vaccination
Self-sampling
First-void urine
Serum
Additional relevant MeSH terms:
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Papillomavirus Infections
Papilloma
Virus Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
Tumor Virus Infections
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs