A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.
- Conditions
- Hepatitis B
- Interventions
- Biological: HB-AS02V vaccineBiological: HBVAXPRO vaccine
- Registration Number
- NCT00291980
- Lead Sponsor
- Henogen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 HB-AS02V vaccine HB-AS02V vaccine 2 HBVAXPRO vaccine HBVAXPRO vaccine
- Primary Outcome Measures
Name Time Method Anti-HBs antibody geometric mean concentrations. Month 0 and Month 1
- Secondary Outcome Measures
Name Time Method Seroprotection rates for all subjects Months 0, 1 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 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 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
Trial Locations
- Locations (28)
CHU Tivoli
🇧🇪La Louvière, Belgium
UZ Gasthuisberg Leuven Nierziekten
🇧🇪Leuven, Belgium
CHU Andre VESALE
🇧🇪Montigny le tilleul, Belgium
O.L.Vrouwziekenhuis Aalst
🇧🇪Aalst, Belgium
RHMS Clinique Louis Caty Baudour
🇧🇪Baudour, Belgium
CHU Brugmann (site V Horta) Service de néphrologie
🇧🇪Bruxelles, Belgium
ULB Hôpital Erasme Département de Néphrologie
🇧🇪Bruxelles, Belgium
UZ AntwerpenDienst nefrologie
🇧🇪Edegem, Belgium
UZ Gent
🇧🇪Gent, Belgium
RHMS TournayService de néphrologie
🇧🇪Tournai, Belgium
Hospital JihlavaVrchlického
🇨🇿Jihlava, Czech Republic
Regional Hospital Liberec
🇨🇿Liberec, Czech Republic
Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
🇨🇿Olomouc, Czech Republic
Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
🇨🇿Pardubice, Czech Republic
Dept. of Internal Medicine StrahovSermirska 5
🇨🇿Prague, Czech Republic
Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
🇨🇿Sokolov, Czech Republic
Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
🇭🇺Eger, Hungary
Vaszary Kolos HospitalFresenius Dialysis Center
🇭🇺Esztergom, Hungary
Petz Aladár Teaching Hospital Vasvári
🇭🇺Győr, Hungary
Vas and Szombathely County Markusovszky Hospital
🇭🇺Szombathely, Hungary
CHU Hôpital civil de
🇧🇪Charleroi, Belgium
RHMS La Madeleine ATH
🇧🇪ATH, Belgium
Cliniques universitaires Saint Luc
🇧🇪Bruxelles, Belgium
Fresenius Medical Care - DS Prague 4
🇨🇿Prague, Czech Republic
Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
🇭🇺Hatvan, Hungary
Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
🇨🇿Hradec Kralove, Czech Republic
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
🇨🇿Ostrava - Poruba, Czech Republic
University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
🇭🇺Debrecen, Hungary