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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
20µg, Month 0, 2 and 6
20 µg,Months 0, 1, 2 and 6
O.L.Vrouwziekenhuis Aalst
Aalst, Belgium
Anti-HBs seroprotection rate at Month 2.
Time frame: Month 0 and 2
Anti-HBs antibody concentrations
Time frame: Months 0, 1, 2, 3, 6 and 7
Anti-HBs seroprotection rates for all subjects.
Time frame: Months 0, 1, 2, 3, 6 and 7
Anti-HBs seropositivity rates for all subjects
Time frame: 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.
Time frame: Months 0, 1, 2, 3, 6 and 7
Anti-HBs geometric mean concentrations calculated for all subjects.
Time frame: Months 0, 1, 2, 3, 6 and 7
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
Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group.
Time frame: Month 0 and 7
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
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.
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RHMS La Madeleine ATH
Ath, Belgium
RHMS Clinique Louis Caty Baudour
Baudour, Belgium
AZ -VUB Dienst Nefrologie
Brussels, Belgium
Cliniques universitaires Saint Luc
Brussels, Belgium
CHU Brugmann (site V Horta) Service de néphrologie
Brussels, Belgium
ULB Hôpital Erasme Département de Néphrologie
Brussels, Belgium
CHU Hôpital civil de
Charleroi, Belgium
UZ AntwerpenDienst nefrologie
Edegem, Belgium
UZ Gent
Ghent, Belgium
...and 14 more locations
Time frame: Month 0, 1, 2, 3, 6 and 7
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7.
Time frame: Month 0 to 7