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. - Full Text View

Sponsor:	Henogen
Collaborator:	GlaxoSmithKline
Information provided by:	Henogen
ClinicalTrials.gov Identifier:	NCT00291941

Purpose

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.

Condition	Intervention	Phase
Hepatitis B	Biological: Henogen HBV vaccine Biological: FENDRIX	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, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive.

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 at Month 2. [ Time Frame: Month 0 and 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
Anti-HBs seroprotection rates for all subjects. [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
Anti-HBs seropositivity rates for all subjects [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects. [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
Anti-HBs geometric mean concentrations calculated for all subjects. [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
Anti-RF-1 seropositivity rates (defined as the percentage of subjects with anti-RF-1 like antibody concentrations superior or equal to 33 EU/ml, the assay cut-off) in a random subset of 50 subjects per group. [ Time Frame: Months 0 and 7 ] [ Designated as safety issue: No ]
Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group. [ Time Frame: Month 0 and 7 ] [ Designated as safety issue: No ]
Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms during a 4-day follow-up (i.e. Day 0 to Day 3) after each vaccination and overall. [ Time Frame: Month 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: Yes ]
Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall. [ Time Frame: Month 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: Yes ]
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7. [ Time Frame: Month 0 to 7 ] [ Designated as safety issue: Yes ]

Enrollment:	300
Study Start Date:	February 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Henogen HB vaccine	Biological: Henogen HBV vaccine 20µg, Month 0, 2 and 6
Active Comparator: 2 Fendrix vaccine	Biological: FENDRIX 20 µg,Months 0, 1, 2 and 6

Detailed Description:

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 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 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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291941

Locations

Belgium
O.L.Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
RHMS La Madeleine ATH
ATH, Belgium, 7800
RHMS Clinique Louis Caty Baudour
Baudour, Belgium, 7331
CHU Brugmann (site V Horta) Service de néphrologie
Bruxelles, Belgium, B-1020
AZ -VUB Dienst Nefrologie
Bruxelles, Belgium, 1090
ULB Hôpital Erasme Département de Néphrologie
Bruxelles, Belgium
Cliniques universitaires Saint Luc
Bruxelles, Belgium, 1200
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
Dept. of Heamodialysis Hospital JihlavaVrchlického
Jihlava, Czech Republic, 59586 33
Regional Hospital Liberec
Liberec, Czech Republic, 46063
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
Ostrava - Poruba, Czech Republic, 1790708 52
Dept. of Internal Medicine StrahovSermirska 5
Prague, Czech Republic, 169 00
Masaryk´s Hospital Socialni pece 3316/12A
Usti nad Labem, Czech Republic, 401 13
Hungary
St. Rókus Hospital
Budapest, Hungary, 1085
St. István Hospital
Budapest, Hungary, 1096
Petz Aladár Teaching Hospital Vasvári
Győr, Hungary, H-9023
Pest County Flór Ferenc Hospital
Kistarcsa, Hungary, 2143
Vas and Szombathely County Markusovszky Hospital
Szombathely, Hungary, 9700

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:	NCT00291941 History of Changes
Obsolete Identifiers:	NCT00739726
Other Study ID Numbers:	HN014/HBV-001 (105757)
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

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