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

NCT00291954 | Completed Phase 3

• 1 other identifier: HN017/HBV-003 (105762)
• Study Type: interventional
• Target: 257
• Locations: 3 countries
• Sites: 25

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.

Conditions

Hepatitis B

Keywords

Dialysis; Pre-dialysis; Hepatitis B vaccine; Prophylaxis hepatitis B infection

Outcome Measures

Primary Outcomes (1)

• Anti-HBs seroprotection rate

  Month 2

Secondary Outcomes (7)

• Anti-HBs Seroprotection rates for all subjects.

  Months 0, 1 and 2

• Anti-HBs Seropositivity rates for all subjects.

  Months 0, 1 and 2

• Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects

  Months 0, 1 and 2

• Anti-HBs Geometric Mean Concentrations calculated for all subjects.

  Months 0, 1 and 2

• 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

  Month 0, 1 and 2

Study Arms (2)

1

EXPERIMENTAL

Henogen hepatitis B vaccine

Biological: HB-AS02V

2

ACTIVE COMPARATOR

HBVAXPRO hepatitis B vaccine

Biological: HBVAXPRO vaccine

Interventions

HB-AS02V BIOLOGICAL

HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1

1

HBVAXPRO vaccine BIOLOGICAL

HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1

2

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Henogen: lead
• GlaxoSmithKline: collaborator

Study Sites (25)

O.L.Vrouwziekenhuis Aalst

Aalst, 9300, Belgium

Location

RHMS La Madeleine ATH

Ath, 7800, Belgium

Location

RHMS Clinique Louis Caty Baudour

Baudour, 7331, Belgium

Location

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

Location

CHU Brugmann (site V Horta) Service de néphrologie

Brussels, B-1020, Belgium

Location

ULB Hôpital Erasme Département de Néphrologie

Brussels, Belgium

Location

CHU Hôpital civil de

Charleroi, 6000, Belgium

Location

UZ AntwerpenDienst nefrologie

Edegem, B-2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

CHU Tivoli

La Louvière, 7100, Belgium

Location

UZ Gasthuisberg Leuven Nierziekten

Leuven, 3000, Belgium

Location

CHU Andre VESALE

Montigny-le-Tilleul, 6110, Belgium

Location

RHMS TournayService de néphrologie

Tournai, 7500, Belgium

Location

Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska

Hradec Králové, 581500 05, Czechia

Location

Dept. of Heamodialysis Hospital JihlavaVrchlického

Jihlava, 59586 33, Czechia

Location

Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova

Olomouc, 6775 20, Czechia

Location

Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic

Ostrava - Poruba, 1790708 52, Czechia

Location

Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska

Pardubice, 44532 03, Czechia

Location

Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska

Sokolov, 1863356 01, Czechia

Location

University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department

Debrecen, .H-4012, Hungary

Location

Markhot Ferenc County HospitalFresenius Dialysis Center Baktai

Eger, H-3300, Hungary

Location

Vaszary Kolos HospitalFresenius Dialysis Center

Esztergom, H-2500, Hungary

Location

Petz Aladár Teaching Hospital Vasvári

Győr, H-9023, Hungary

Location

Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .

Hatvan, H-3000, Hungary

Location

Zala County HospitalII. Medical Department Nephrology Zrinyi

Zalaegerszeg, H-8900, Hungary

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Christian Tielemans, MD, PhD

  ULB Hôpital Erasme Département de Néphrologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: March 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 28, 2008

Record last verified: 2008-08

Locations

HU (6); CZ (6); BE (13)