The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more immunogenic vaccine, allowing higher antibody concentrations, would be a benefit for this population.
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 3 visits and blood samples will taken at each of these visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
185
HB-AS02V (20µg HBsAg) will be administered at Month 0
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0
O.L.Vrouwziekenhuis Aalst
Aalst, Belgium
RHMS La Madeleine ATH
Ath, Belgium
RHMS Clinique Louis Caty Baudour
Baudour, Belgium
Cliniques universitaires Saint Luc
Brussels, Belgium
CHU Brugmann (site V Horta) Service de néphrologie
Brussels, Belgium
ULB Hôpital Erasme Département de Néphrologie
Anti-HBs antibody geometric mean concentrations.
Time frame: Month 0 and Month 1
Seroprotection rates for all subjects
Time frame: Months 0, 1
Seropositivity rates for all subjects
Time frame: Month 0 and at Month 1
Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects
Time frame: Month 0 and at Month 1
Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects
Time frame: Month 0 and Month 1
Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms during the 4-day follow-up after vaccination
Time frame: Month 0
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after vaccination
Time frame: Month 0
Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1
Time frame: Month 0 to 1
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Brussels, Belgium
CHU Hôpital civil de
Charleroi, Belgium
UZ AntwerpenDienst nefrologie
Edegem, Belgium
UZ Gent
Ghent, Belgium
CHU Tivoli
La Louvière, Belgium
...and 18 more locations