Hepatitis B
Conditions
Keywords
Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis hepatitis B infection
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALHB-AS02V vaccine
HB-AS02V (20µg HBsAg) will be administered at Month 0
BIOLOGICALHBVAXPRO vaccine
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0
Sponsors
GlaxoSmithKline
Henogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects whom the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. * 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/ subject's parents or guardians. * Pre-dialysis patients, peritoneal dialysis patients and patients on haemodialysis. Pre-dialysis patients is defined as a subject with a documented creatinine clearance of les or equal to 30 ml/min. * Seronegative for anti-HBc antibodies and for HBsAg at screening. * Documented previous hepatitis B vaccination with one full primary course of licensed vaccine (the cumulative dose for primary vaccination is at least 160 mg of hepatitis B vaccine) with or without subsequent boosters. The last dose should have been administered at least three months before the planned dose of study vaccine in this study. * Documented response to previous hepatitis B vaccination (i.e. anti-HBs antibody concentrations ³ 10 mIU/ml after primary vaccination or after booster/s with licensed vaccine), but for whom there is a loss of anti-HBs antibody concentrations below 10 mIU/ml at the time of inclusion into the study. Patients who have antibody concentrations below 50 mIU/ml at the time of inclusion will also be recruited provided that this antibody concentration is less than half of the highest documented antibody response achieved after primary vaccination or booster/s. The interval between the blood sample corresponding to the documented response and the hepatitis B vaccine dose received prior to this blood sample should be at least 25 days * If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used medically-approved contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion criteria
* Subjects who have participated in the HN014/HBV-001 or HN017/HBV-003 study * Use of any investigational or non-registered drug or vaccine within 30 days preceding the study vaccine administration, or planned use during the study period. * Use of any registered vaccine within 7 days preceding the study vaccine administration. * History of hepatitis B infection. * Known exposure to hepatitis B virus within six 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 equal or superior to 37.5 °C (or 37 °C in Czech Republic). * Pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HBs antibody geometric mean concentrations. | Month 0 and Month 1 |
Secondary
| Measure | Time frame |
|---|---|
| Seropositivity rates for all subjects | Month 0 and at Month 1 |
| Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects | Month 0 and at Month 1 |
| Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects | Month 0 and Month 1 |
| Seroprotection rates for all subjects | Months 0, 1 |
| 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 | Month 0 |
| Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1 | Month 0 to 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 | Month 0 |
Countries
Belgium, Czechia, Hungary
Outcome results
None listed