Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™

November 18, 2009 updated by: Henogen

A Study to Evaluate the Persistence of Anti-HBs Antibodies at Months 12, 24 and 36 in Pre-dialysis or Dialysis Patients Who Have Received a Primary Vaccination Course of Either Henogen's HBV Vaccine, HB-AS02V or GSK Biological's Fendrix™

The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives & outcome measures of the extension phase at Months 12, 24 and 36. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • O.L.Vrouwziekenhuis Aalst
      • Ath, Belgium, 7800
        • RHMS La Madeleine ATH
      • Baudour, Belgium, 7331
        • RHMS Clinique Louis Caty Baudour
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Bruxelles, Belgium, 1020
        • CHU Brugmann (site V Horta) Service de néphrologie
      • Bruxelles, Belgium, 1070
        • ULB Hôpital Erasme Département de Néphrologie
      • Bruxelles, Belgium, 1090
        • AZ -VUB Dienst Nefrologie
      • Charleroi, Belgium, 6000
        • CHU Hôpital civil de
      • Gent, Belgium, 9000
        • UZ Gent
      • La Louvière, Belgium, 7100
        • Chu Tivoli
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg Leuven Nierziekten
      • Montigny Le Tilleul, Belgium, 6110
        • CHU Andre VESALE
      • Tournai, Belgium, 7500
        • RHMS TournayService de néphrologie
  • Czech Republic
      • Jihlava, Czech Republic, 59586 33
        • Hospital JihlavaVrchlického
      • Liberec, Czech Republic, 46063
        • Regional Hospital Liberec
      • Ostrava, Czech Republic, 708 52
        • University Hospital with Outpatient Clinic Ostrava
      • Prague, Czech Republic, 169 00
        • Dept. of Internal Medicine StrahovSermirska 5
      • Usti Nad Labem, Czech Republic, 401 13
        • Masaryk´s Hospital Socialni pece 3316/12A
  • Hungary
      • Budapest, Hungary, 1096
        • St. István Hospital
      • Budapest, Hungary, 1085
        • St. Rókus Hospital
      • Győr, Hungary, 9023
        • Petz Aladár Teaching Hospital
      • Kistarcsa, Hungary, 2143
        • Pest County Flór Ferenc Hospital
      • Szombathely, Hungary, 9700
        • Vas and Szombathely County Markusovszky Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
  • Subjects who completed the full course of primary vaccination.

Exclusion Criteria:

  • Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
  • Any confirmed or suspected human immunodeficiency virus (HIV) infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Henogen Hepatitis B vaccine for uremic patients
Biological: Henogen HB vaccine
Month 12, 24 and 36
Active Comparator: 2
Fendrix hepatitis B vaccine for uremic patients
Biological: Fendrix vaccine
Month 12, 24 and 36

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs antibody concentrations
Time Frame: Months 12, 24 and 36.
Months 12, 24 and 36.

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of immune response
Time Frame: Month 12, 24 and 36
Month 12, 24 and 36
SAEs retrospective reporting
Time Frame: Month 12, 24 and 36
Month 12, 24 and 36
RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001).
Time Frame: Month 12, 24 and 36
Month 12, 24 and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henogen

Investigators

  • Principal Investigator: Joëlle Nortier, MD, PhD, ULB Hôpital Erasme Département de Néphrologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

November 19, 2009

Last Update Submitted That Met QC Criteria

November 18, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN015/HBV-EXT001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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