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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

Tracking Information
First Submitted Date March 10, 2016
First Posted Date March 21, 2016
Last Update Posted Date June 15, 2017
Study Start Date September 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2016)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02714114 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 18, 2016)
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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study)
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
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).
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
First-void urine samples and Blood samples
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).

Condition Human Papilloma Virus Infection
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).
    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
Study Groups/Cohorts
  • 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.

    Interventions:
    • 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.

    Interventions:
    • Other: First-void urine collection
    • Other: Blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 18, 2016)
57
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 26 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02714114
Other Study ID Numbers B300201525584
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Pierre Van Damme, Universiteit Antwerpen
Study Sponsor Universiteit Antwerpen
Collaborators Research Foundation Flanders
Investigators
Principal Investigator: Pierre Van Damme, Prof MD PhD Universiteit Antwerpen
PRS Account Universiteit Antwerpen
Verification Date June 2017