A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.

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, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive.

The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.

Study Type

Interventional

Enrollment (Actual)

300

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
      • Bruxelles, Belgium, 1090
        • AZ -VUB Dienst Nefrologie
      • 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
      • Jihlava, Czech Republic, 59586 33
        • Dept. of Heamodialysis Hospital JihlavaVrchlického
      • Liberec, Czech Republic, 46063
        • Regional Hospital Liberec
      • Ostrava - Poruba, Czech Republic, 1790708 52
        • Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
      • 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, H-9023
        • Petz Aladár Teaching Hospital Vasvári
      • 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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A male or female subject 15 years of age or older at the time of the study entry.
  • Written informed consent obtained from the subject/ from the parent or guardian of the subject.
  • Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
  • Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
  • Non-childbearing potential female

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Use of any registered vaccine within 7 days before the first dose of study vaccine.
  • Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
  • History of hepatitis B infection.
  • Known exposure to hepatitis B virus within 6 months.
  • Use of immunoglobulins within six months preceding the first study vaccination.
  • Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
  • Any confirmed or suspected human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature < 37.5°C (or 37 °C in Czech Republic).
  • Oral/axillary temperature superior or equal to 37.5°C (or 37 °C in Czech Republic).
  • 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 HB vaccine
Biological: Henogen HBV vaccine
20µg, Month 0, 2 and 6
Active Comparator: 2
Fendrix vaccine
Biological: FENDRIX
20 µg,Months 0, 1, 2 and 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs seroprotection rate at Month 2.
Time Frame: Month 0 and 2
Month 0 and 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs antibody concentrations
Time Frame: Months 0, 1, 2, 3, 6 and 7
Months 0, 1, 2, 3, 6 and 7
Anti-HBs seroprotection rates for all subjects.
Time Frame: Months 0, 1, 2, 3, 6 and 7
Months 0, 1, 2, 3, 6 and 7
Anti-HBs seropositivity rates for all subjects
Time Frame: Months 0, 1, 2, 3, 6 and 7
Months 0, 1, 2, 3, 6 and 7
Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects.
Time Frame: Months 0, 1, 2, 3, 6 and 7
Months 0, 1, 2, 3, 6 and 7
Anti-HBs geometric mean concentrations calculated for all subjects.
Time Frame: Months 0, 1, 2, 3, 6 and 7
Months 0, 1, 2, 3, 6 and 7
Anti-RF-1 seropositivity rates (defined as the percentage of subjects with anti-RF-1 like antibody concentrations superior or equal to 33 EU/ml, the assay cut-off) in a random subset of 50 subjects per group.
Time Frame: Months 0 and 7
Months 0 and 7
Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group.
Time Frame: Month 0 and 7
Month 0 and 7
Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms during a 4-day follow-up (i.e. Day 0 to Day 3) after each vaccination and overall.
Time Frame: Month 0, 1, 2, 3, 6 and 7
Month 0, 1, 2, 3, 6 and 7
Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall.
Time Frame: Month 0, 1, 2, 3, 6 and 7
Month 0, 1, 2, 3, 6 and 7
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7.
Time Frame: Month 0 to 7
Month 0 to 7

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

February 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 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

  • HN014/HBV-001 (105757)

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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