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 - Full Text View

Sponsor:	Henogen
Collaborator:	GlaxoSmithKline
Information provided by:	Henogen
ClinicalTrials.gov Identifier:	NCT00291954

Purpose

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	Intervention	Phase
Hepatitis B	Biological: HB-AS02V Biological: HBVAXPRO vaccine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Recombinant hepatitis B vaccine Hepatitis B Vaccines Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Henogen:

Primary Outcome Measures:

Anti-HBs seroprotection rate [ Time Frame: Month 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anti-HBs Seroprotection rates for all subjects. [ Time Frame: Months 0, 1 and 2 ] [ Designated as safety issue: No ]
Anti-HBs Seropositivity rates for all subjects. [ Time Frame: Months 0, 1 and 2 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Anti-HBs Geometric Mean Concentrations calculated for all subjects. [ Time Frame: Months 0, 1 and 2 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2 [ Time Frame: Month 0 to 2 ] [ Designated as safety issue: Yes ]

Enrollment:	257
Study Start Date:	March 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291954

Locations

Belgium
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
ULB Hôpital Erasme Département de Néphrologie
Bruxelles, Belgium
CHU Brugmann (site V Horta) Service de néphrologie
Bruxelles, Belgium, B-1020
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
CHU Andre VESALE
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
Hungary
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

Henogen

GlaxoSmithKline

Investigators

Principal Investigator:

Christian Tielemans, MD, PhD

ULB Hôpital Erasme Département de Néphrologie

More Information

No publications provided

Responsible Party:	Sophie Houard CSO, Henogen
ClinicalTrials.gov Identifier:	NCT00291954 History of Changes
Obsolete Identifiers:	NCT00671762
Other Study ID Numbers:	HN017/HBV-003 (105762)
Study First Received:	February 14, 2006
Last Updated:	August 27, 2008
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Henogen:

Dialysis
Pre-dialysis
Hepatitis B vaccine
Prophylaxis hepatitis B infection

Additional relevant MeSH terms:

Hepatitis
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

ClinicalTrials.gov processed this record on February 09, 2012