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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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HB-AS02V
HBVAXPRO vaccine
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 hepatitis B infection

Eligibility Criteria

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

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

Sites / Locations

  • O.L.Vrouwziekenhuis Aalst
  • RHMS La Madeleine ATH
  • RHMS Clinique Louis Caty Baudour
  • 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
  • Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
  • Dept. of Heamodialysis Hospital JihlavaVrchlického
  • Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
  • Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
  • Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
  • Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
  • University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
  • Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
  • Vaszary Kolos HospitalFresenius Dialysis Center
  • Petz Aladár Teaching Hospital Vasvári
  • Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
  • Zala County HospitalII. Medical Department Nephrology Zrinyi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Henogen hepatitis B vaccine

HBVAXPRO hepatitis B vaccine

Outcomes

Primary Outcome Measures

Anti-HBs seroprotection rate

Secondary Outcome Measures

Anti-HBs Seroprotection rates for all subjects.
Anti-HBs Seropositivity rates for all subjects.
Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects
Anti-HBs Geometric Mean Concentrations calculated for all subjects.
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
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
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2

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
NCT00291954
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Henogen
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

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 hepatitis B infection

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Henogen hepatitis B vaccine
Arm Title
2
Arm Type
Active Comparator
Arm Description
HBVAXPRO hepatitis B vaccine
Intervention Type
Biological
Intervention Name(s)
HB-AS02V
Intervention Description
HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
Intervention Type
Biological
Intervention Name(s)
HBVAXPRO vaccine
Intervention Description
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1
Primary Outcome Measure Information:
Title
Anti-HBs seroprotection rate
Time Frame
Month 2
Secondary Outcome Measure Information:
Title
Anti-HBs Seroprotection rates for all subjects.
Time Frame
Months 0, 1 and 2
Title
Anti-HBs Seropositivity rates for all subjects.
Time Frame
Months 0, 1 and 2
Title
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
Title
Anti-HBs Geometric Mean Concentrations calculated for all subjects.
Time Frame
Months 0, 1 and 2
Title
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
Title
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
Title
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2
Time Frame
Month 0 to 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
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
Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
City
Hradec Kralove
ZIP/Postal Code
581500 05
Country
Czech Republic
Facility Name
Dept. of Heamodialysis Hospital JihlavaVrchlického
City
Jihlava
ZIP/Postal Code
59586 33
Country
Czech Republic
Facility Name
Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
City
Olomouc
ZIP/Postal Code
6775 20
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
Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
City
Pardubice
ZIP/Postal Code
44532 03
Country
Czech Republic
Facility Name
Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
City
Sokolov
ZIP/Postal Code
1863356 01
Country
Czech Republic
Facility Name
University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
City
Debrecen
ZIP/Postal Code
.H-4012
Country
Hungary
Facility Name
Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
City
Eger
ZIP/Postal Code
H-3300
Country
Hungary
Facility Name
Vaszary Kolos HospitalFresenius Dialysis Center
City
Esztergom
ZIP/Postal Code
H-2500
Country
Hungary
Facility Name
Petz Aladár Teaching Hospital Vasvári
City
Győr
ZIP/Postal Code
H-9023
Country
Hungary
Facility Name
Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
City
Hatvan
ZIP/Postal Code
H-3000
Country
Hungary
Facility Name
Zala County HospitalII. Medical Department Nephrology Zrinyi
City
Zalaegerszeg
ZIP/Postal Code
H-8900
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

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

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