Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291954
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : August 28, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: HB-AS02V Biological: HBVAXPRO vaccine Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : March 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Anti-HBs seroprotection rate [ Time Frame: Month 2 ]

Secondary Outcome Measures :
  1. Anti-HBs Seroprotection rates for all subjects. [ Time Frame: Months 0, 1 and 2 ]
  2. Anti-HBs Seropositivity rates for all subjects. [ Time Frame: Months 0, 1 and 2 ]
  3. 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 ]
  4. Anti-HBs Geometric Mean Concentrations calculated for all subjects. [ Time Frame: Months 0, 1 and 2 ]
  5. 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 ]
  6. 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 ]
  7. Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2 [ Time Frame: Month 0 to 2 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00291954

Layout table for location information
O.L.Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
RHMS La Madeleine ATH
ATH, Belgium, 7800
RHMS Clinique Louis Caty Baudour
Baudour, Belgium, 7331
Cliniques universitaires Saint Luc
Bruxelles, Belgium, 1200
CHU Brugmann (site V Horta) Service de néphrologie
Bruxelles, Belgium, B-1020
ULB Hôpital Erasme Département de Néphrologie
Bruxelles, Belgium
CHU Hôpital civil de
Charleroi, Belgium, 6000
UZ AntwerpenDienst nefrologie
Edegem, Belgium, B-2650
UZ Gent
Gent, Belgium, 9000
CHU Tivoli
La Louvière, Belgium, 7100
UZ Gasthuisberg Leuven Nierziekten
Leuven, Belgium, 3000
Montigny le tilleul, Belgium, 6110
RHMS TournayService de néphrologie
Tournai, Belgium, 7500
Czech Republic
Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
Hradec Kralove, Czech Republic, 581500 05
Dept. of Heamodialysis Hospital JihlavaVrchlického
Jihlava, Czech Republic, 59586 33
Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
Olomouc, Czech Republic, 6775 20
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
Ostrava - Poruba, Czech Republic, 1790708 52
Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
Pardubice, Czech Republic, 44532 03
Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
Sokolov, Czech Republic, 1863356 01
University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
Debrecen, Hungary, .H-4012
Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
Eger, Hungary, H-3300
Vaszary Kolos HospitalFresenius Dialysis Center
Esztergom, Hungary, H-2500
Petz Aladár Teaching Hospital Vasvári
Győr, Hungary, H-9023
Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
Hatvan, Hungary, H-3000
Zala County HospitalII. Medical Department Nephrology Zrinyi
Zalaegerszeg, Hungary, H-8900
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Christian Tielemans, MD, PhD ULB Hôpital Erasme Département de Néphrologie

Layout table for additonal information
Responsible Party: Sophie Houard CSO, Henogen Identifier: NCT00291954     History of Changes
Obsolete Identifiers: NCT00671762
Other Study ID Numbers: HN017/HBV-003 (105762)
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: August 28, 2008
Last Verified: August 2008
Keywords provided by Henogen:
Hepatitis B vaccine
Prophylaxis hepatitis B infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs