Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine 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 4 visits and blood samples will taken at each of these visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
257
HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1
Anti-HBs seroprotection rate
Time frame: Month 2
Anti-HBs Seroprotection rates for all subjects.
Time frame: Months 0, 1 and 2
Anti-HBs Seropositivity rates for all subjects.
Time frame: Months 0, 1 and 2
Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects
Time frame: Months 0, 1 and 2
Anti-HBs Geometric Mean Concentrations calculated for all subjects.
Time frame: Months 0, 1 and 2
Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms reported during the 4-day follow-up period after each vaccination and overall
Time frame: Month 0, 1 and 2
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall
Time frame: Month 0, 1 and 2
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2
Time frame: Month 0 to 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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