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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.

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Henogen HBV vaccine
FENDRIX
Sponsored by
Henogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • O.L.Vrouwziekenhuis Aalst
  • RHMS La Madeleine ATH
  • RHMS Clinique Louis Caty Baudour
  • AZ -VUB Dienst Nefrologie
  • Cliniques universitaires Saint Luc
  • CHU Brugmann (site V Horta) Service de néphrologie
  • ULB Hôpital Erasme Département de Néphrologie
  • CHU Hôpital civil de
  • UZ AntwerpenDienst nefrologie
  • UZ Gent
  • CHU Tivoli
  • UZ Gasthuisberg Leuven Nierziekten
  • CHU Andre VESALE
  • RHMS TournayService de néphrologie
  • Dept. of Heamodialysis Hospital JihlavaVrchlického
  • Regional Hospital Liberec
  • Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
  • Dept. of Internal Medicine StrahovSermirska 5
  • Masaryk´s Hospital Socialni pece 3316/12A
  • St. Rókus Hospital
  • St. István Hospital
  • Petz Aladár Teaching Hospital Vasvári
  • Pest County Flór Ferenc Hospital
  • Vas and Szombathely County Markusovszky Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Henogen HB vaccine

Fendrix vaccine

Outcomes

Primary Outcome Measures

Anti-HBs seroprotection rate at Month 2.

Secondary Outcome Measures

Anti-HBs antibody concentrations
Anti-HBs seroprotection rates for all subjects.
Anti-HBs seropositivity rates for all subjects
Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects.
Anti-HBs geometric mean concentrations calculated for all subjects.
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.
Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group.
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.
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.
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7.

Full Information

First Posted
February 14, 2006
Last Updated
August 27, 2008
Sponsor
Henogen
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00291941
Brief Title
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.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Henogen
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Henogen HB vaccine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Fendrix vaccine
Intervention Type
Biological
Intervention Name(s)
Henogen HBV vaccine
Intervention Description
20µg, Month 0, 2 and 6
Intervention Type
Biological
Intervention Name(s)
FENDRIX
Intervention Description
20 µg,Months 0, 1, 2 and 6
Primary Outcome Measure Information:
Title
Anti-HBs seroprotection rate at Month 2.
Time Frame
Month 0 and 2
Secondary Outcome Measure Information:
Title
Anti-HBs antibody concentrations
Time Frame
Months 0, 1, 2, 3, 6 and 7
Title
Anti-HBs seroprotection rates for all subjects.
Time Frame
Months 0, 1, 2, 3, 6 and 7
Title
Anti-HBs seropositivity rates for all subjects
Time Frame
Months 0, 1, 2, 3, 6 and 7
Title
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
Title
Anti-HBs geometric mean concentrations calculated for all subjects.
Time Frame
Months 0, 1, 2, 3, 6 and 7
Title
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
Title
Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group.
Time Frame
Month 0 and 7
Title
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
Title
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
Title
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7.
Time Frame
Month 0 to 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Tielemans, MD, PhD
Organizational Affiliation
ULB Hôpital Erasme Département de Néphrologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
O.L.Vrouwziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
RHMS La Madeleine ATH
City
ATH
ZIP/Postal Code
7800
Country
Belgium
Facility Name
RHMS Clinique Louis Caty Baudour
City
Baudour
ZIP/Postal Code
7331
Country
Belgium
Facility Name
AZ -VUB Dienst Nefrologie
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques universitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU Brugmann (site V Horta) Service de néphrologie
City
Bruxelles
ZIP/Postal Code
B-1020
Country
Belgium
Facility Name
ULB Hôpital Erasme Département de Néphrologie
City
Bruxelles
Country
Belgium
Facility Name
CHU Hôpital civil de
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ AntwerpenDienst nefrologie
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Gasthuisberg Leuven Nierziekten
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Andre VESALE
City
Montigny le tilleul
ZIP/Postal Code
6110
Country
Belgium
Facility Name
RHMS TournayService de néphrologie
City
Tournai
ZIP/Postal Code
7500
Country
Belgium
Facility Name
Dept. of Heamodialysis Hospital JihlavaVrchlického
City
Jihlava
ZIP/Postal Code
59586 33
Country
Czech Republic
Facility Name
Regional Hospital Liberec
City
Liberec
ZIP/Postal Code
46063
Country
Czech Republic
Facility Name
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
City
Ostrava - Poruba
ZIP/Postal Code
1790708 52
Country
Czech Republic
Facility Name
Dept. of Internal Medicine StrahovSermirska 5
City
Prague
ZIP/Postal Code
169 00
Country
Czech Republic
Facility Name
Masaryk´s Hospital Socialni pece 3316/12A
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
St. Rókus Hospital
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
St. István Hospital
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Petz Aladár Teaching Hospital Vasvári
City
Győr
ZIP/Postal Code
H-9023
Country
Hungary
Facility Name
Pest County Flór Ferenc Hospital
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Vas and Szombathely County Markusovszky Hospital
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

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.

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