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.

Hepatitis B Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291941
• Other study ID #: HN014/HBV-001 (105757)
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2006
• Last updated: August 27, 2008
• Start date: February 2006
• Est. completion date: March 2007

Study information

• Verified date: August 2008
• Source: Henogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00739726

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Henogen HBV vaccine
20µg, Month 0, 2 and 6
• FENDRIX
20 µg,Months 0, 1, 2 and 6

Locations

Country	Name	City	State
Belgium	O.L.Vrouwziekenhuis Aalst	Aalst
Belgium	RHMS La Madeleine ATH	ATH
Belgium	RHMS Clinique Louis Caty Baudour	Baudour
Belgium	AZ -VUB Dienst Nefrologie	Bruxelles
Belgium	CHU Brugmann (site V Horta) Service de néphrologie	Bruxelles
Belgium	Cliniques universitaires Saint Luc	Bruxelles
Belgium	ULB Hôpital Erasme Département de Néphrologie	Bruxelles
Belgium	CHU Hôpital civil de	Charleroi
Belgium	UZ AntwerpenDienst nefrologie	Edegem
Belgium	UZ Gent	Gent
Belgium	CHU Tivoli	La Louvière
Belgium	UZ Gasthuisberg Leuven Nierziekten	Leuven
Belgium	CHU Andre VESALE	Montigny le tilleul
Belgium	RHMS TournayService de néphrologie	Tournai
Czech Republic	Dept. of Heamodialysis Hospital JihlavaVrchlického	Jihlava
Czech Republic	Regional Hospital Liberec	Liberec
Czech Republic	Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic	Ostrava - Poruba
Czech Republic	Dept. of Internal Medicine StrahovSermirska 5	Prague
Czech Republic	Masaryk´s Hospital Socialni pece 3316/12A	Usti nad Labem
Hungary	St. István Hospital	Budapest
Hungary	St. Rókus Hospital	Budapest
Hungary	Petz Aladár Teaching Hospital Vasvári	Gyor
Hungary	Pest County Flór Ferenc Hospital	Kistarcsa
Hungary	Vas and Szombathely County Markusovszky Hospital	Szombathely

Sponsors (2)

Lead Sponsor	Collaborator
Henogen	GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs seroprotection rate at Month 2.		Month 0 and 2	No
Secondary	Anti-HBs antibody concentrations		Months 0, 1, 2, 3, 6 and 7	No
Secondary	Anti-HBs seroprotection rates for all subjects.		Months 0, 1, 2, 3, 6 and 7	No
Secondary	Anti-HBs seropositivity rates for all subjects		Months 0, 1, 2, 3, 6 and 7	No
Secondary	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	No
Secondary	Anti-HBs geometric mean concentrations calculated for all subjects.		Months 0, 1, 2, 3, 6 and 7	No
Secondary	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.		Months 0 and 7	No
Secondary	Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group.		Month 0 and 7	No
Secondary	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.		Month 0, 1, 2, 3, 6 and 7	Yes
Secondary	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.		Month 0, 1, 2, 3, 6 and 7	Yes
Secondary	Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7.		Month 0 to 7	Yes