Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination

August 27, 2008 updated by: Henogen

A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1months to That of Aventis Pasteur MSD's Hepatitis B Given at 0, 1 Months in Pre-Dialysis, and Dialysis Patients Did Not Respond to Previous Hepatitis B Vaccination

Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 4 visits and blood samples will taken at each of these visits.

Study Type

Interventional

Enrollment (Actual)

257

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
      • ATH, Belgium, 7800
        • RHMS La Madeleine ATH
      • Aalst, Belgium, 9300
        • O.L.Vrouwziekenhuis Aalst
      • Baudour, Belgium, 7331
        • RHMS Clinique Louis Caty Baudour
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Bruxelles, Belgium, B-1020
        • CHU Brugmann (site V Horta) Service de néphrologie
      • Bruxelles, Belgium
        • ULB Hôpital Erasme Département de Néphrologie
      • Charleroi, Belgium, 6000
        • CHU Hôpital civil de
      • Edegem, Belgium, B-2650
        • UZ AntwerpenDienst nefrologie
      • 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
      • Hradec Kralove, Czech Republic, 581500 05
        • Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
      • Jihlava, Czech Republic, 59586 33
        • Dept. of Heamodialysis Hospital JihlavaVrchlického
      • Olomouc, Czech Republic, 6775 20
        • Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
      • Ostrava - Poruba, Czech Republic, 1790708 52
        • Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
      • Pardubice, Czech Republic, 44532 03
        • Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
      • Sokolov, Czech Republic, 1863356 01
        • Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
  • Hungary
      • Debrecen, Hungary, .H-4012
        • University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
      • Eger, Hungary, H-3300
        • Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
      • Esztergom, Hungary, H-2500
        • Vaszary Kolos HospitalFresenius Dialysis Center
      • Győr, Hungary, H-9023
        • Petz Aladár Teaching Hospital Vasvári
      • Hatvan, Hungary, H-3000
        • Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
      • Zalaegerszeg, Hungary, H-8900
        • Zala County HospitalII. Medical Department Nephrology Zrinyi

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • A male or female subject greater than or equal to 15 years of age at the time of study entry
  • Written informed consent obtained from the subject/ from the parent or guardian of the subject.
  • Seronegative for anti-HBc antibodies and for HBsAg at screening.
  • Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
  • Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
  • The last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
  • Documented evidence of non-response to previous hepatitis B vaccination after at least one to maximum three months after the last vaccine dose.

Exclusion criteria

  • Subject included on HN014/HBV-001 study. History of Hepatitis B infection Use of immunoglobulins within six months preceding the first study vaccination.
  • Any confirmed or suspected human immunodeficiency virus (HIV) infection. Pregnant or lactating female

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
Biological: HB-AS02V
HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
Active Comparator: 2
HBVAXPRO hepatitis B vaccine
Biological: HBVAXPRO vaccine
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs seroprotection rate
Time Frame: Month 2
Month 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs Seroprotection rates for all subjects.
Time Frame: Months 0, 1 and 2
Months 0, 1 and 2
Anti-HBs Seropositivity rates for all subjects.
Time Frame: Months 0, 1 and 2
Months 0, 1 and 2
Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects
Time Frame: Months 0, 1 and 2
Months 0, 1 and 2
Anti-HBs Geometric Mean Concentrations calculated for all subjects.
Time Frame: Months 0, 1 and 2
Months 0, 1 and 2
Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms reported during the 4-day follow-up period after each vaccination and overall
Time Frame: Month 0, 1 and 2
Month 0, 1 and 2
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall
Time Frame: Month 0, 1 and 2
Month 0, 1 and 2
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2
Time Frame: Month 0 to 2
Month 0 to 2

Collaborators and Investigators

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

Sponsor

Henogen

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Christian Tielemans, MD, PhD, ULB Hôpital Erasme Département de Néphrologie

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, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (Estimate)

February 15, 2006

Study Record Updates

Last Update Posted (Estimate)

August 28, 2008

Last Update Submitted That Met QC Criteria

August 27, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN017/HBV-003 (105762)

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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