Clinical trial NCT00291941: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Dialysis
Pre-dialysis
Hepatitis B vaccine
Prophylaxis
Lead sponsor: Henogen
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2006-02-15
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Anti-HBs seroprotection rate at Month 2.
timeFrame: Month 0 and 2
Secondary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: Months 0, 1, 2, 3, 6 and 7
measure: Anti-HBs seroprotection rates for all subjects.
timeFrame: Months 0, 1, 2, 3, 6 and 7
measure: Anti-HBs seropositivity rates for all subjects
timeFrame: Months 0, 1, 2, 3, 6 and 7
measure: Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects.
timeFrame: Months 0, 1, 2, 3, 6 and 7
measure: Anti-HBs geometric mean concentrations calculated for all subjects.
timeFrame: Months 0, 1, 2, 3, 6 and 7
measure: 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.
timeFrame: Months 0 and 7
measure: Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group.
timeFrame: Month 0 and 7
measure: 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.
timeFrame: Month 0, 1, 2, 3, 6 and 7
measure: 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.
timeFrame: Month 0, 1, 2, 3, 6 and 7
measure: Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7.
timeFrame: Month 0 to 7
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: O.L.Vrouwziekenhuis Aalst
city: ATH
country: Belgium
facility: RHMS La Madeleine ATH
city: Baudour
country: Belgium
facility: RHMS Clinique Louis Caty Baudour
city: Bruxelles
country: Belgium
facility: AZ -VUB Dienst Nefrologie
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint Luc
city: Bruxelles
country: Belgium
facility: CHU Brugmann (site V Horta) Service de néphrologie
city: Bruxelles
country: Belgium
facility: ULB Hôpital Erasme Département de Néphrologie
city: Charleroi
country: Belgium
facility: CHU Hôpital civil de
city: Edegem
country: Belgium
facility: UZ AntwerpenDienst nefrologie
city: Gent
country: Belgium
facility: UZ Gent
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven Nierziekten
city: Montigny le tilleul
country: Belgium
facility: CHU Andre VESALE
city: Tournai
country: Belgium
facility: RHMS TournayService de néphrologie
city: Jihlava
country: Czech Republic
facility: Dept. of Heamodialysis Hospital JihlavaVrchlického
city: Liberec
country: Czech Republic
facility: Regional Hospital Liberec
city: Ostrava - Poruba
country: Czech Republic
facility: Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
city: Prague
country: Czech Republic
facility: Dept. of Internal Medicine StrahovSermirska 5
city: Usti nad Labem
country: Czech Republic
facility: Masaryk´s Hospital Socialni pece 3316/12A
city: Budapest
country: Hungary
facility: St. Rókus Hospital
city: Budapest
country: Hungary
facility: St. István Hospital
city: Győr
country: Hungary
facility: Petz Aladár Teaching Hospital Vasvári
city: Kistarcsa
country: Hungary
facility: Pest County Flór Ferenc Hospital
city: Szombathely
country: Hungary
facility: Vas and Szombathely County Markusovszky Hospital
Study officials:
affiliation: ULB Hôpital Erasme Département de Néphrologie
name: Christian Tielemans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: