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.

NCT00291941 | Completed Phase 3

• 1 other identifier: HN014/HBV-001 (105757)
• Study Type: interventional
• Target: 300
• Locations: 3 countries
• Sites: 24

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.

Conditions

Hepatitis B

Keywords

Dialysis; Pre-dialysis; Hepatitis B vaccine; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Anti-HBs seroprotection rate at Month 2.

  Month 0 and 2

Secondary Outcomes (10)

• Anti-HBs antibody concentrations

  Months 0, 1, 2, 3, 6 and 7

• Anti-HBs seroprotection rates for all subjects.

  Months 0, 1, 2, 3, 6 and 7

• Anti-HBs seropositivity rates for all subjects

  Months 0, 1, 2, 3, 6 and 7

• Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects.

  Months 0, 1, 2, 3, 6 and 7

• Anti-HBs geometric mean concentrations calculated for all subjects.

  Months 0, 1, 2, 3, 6 and 7

Study Arms (2)

1

EXPERIMENTAL

Henogen HB vaccine

Biological: Henogen HBV vaccine

2

ACTIVE COMPARATOR

Fendrix vaccine

Biological: FENDRIX

Interventions

Henogen HBV vaccine BIOLOGICAL

20µg, Month 0, 2 and 6

1

FENDRIX BIOLOGICAL

20 µg,Months 0, 1, 2 and 6

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henogen: lead
• GlaxoSmithKline: collaborator

Study Sites (24)

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

AZ -VUB Dienst Nefrologie

Brussels, 1090, 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

Dept. of Heamodialysis Hospital JihlavaVrchlického

Jihlava, 59586 33, Czechia

Location

Regional Hospital Liberec

Liberec, 46063, Czechia

Location

Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic

Ostrava - Poruba, 1790708 52, Czechia

Location

Dept. of Internal Medicine StrahovSermirska 5

Prague, 169 00, Czechia

Location

Masaryk´s Hospital Socialni pece 3316/12A

Ústí nad Labem, 401 13, Czechia

Location

St. Rókus Hospital

Budapest, 1085, Hungary

Location

St. István Hospital

Budapest, 1096, Hungary

Location

Petz Aladár Teaching Hospital Vasvári

Győr, H-9023, Hungary

Location

Pest County Flór Ferenc Hospital

Kistarcsa, 2143, Hungary

Location

Vas and Szombathely County Markusovszky Hospital

Szombathely, 9700, Hungary

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Fendrix

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: February 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: August 28, 2008

Record last verified: 2008-08

Locations

HU (5); CZ (5); BE (14)