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.
Hepatitis B
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis hepatitis B infection
Eligibility Criteria
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
Sites / Locations
- O.L.Vrouwziekenhuis Aalst
- RHMS La Madeleine ATH
- RHMS Clinique Louis Caty Baudour
- Cliniques universitaires Saint Luc
- CHU Brugmann (site V Horta) Service de néphrologie
- ULB Hôpital Erasme Département de Néphrologie
- CHU Hôpital civil de
- UZ AntwerpenDienst nefrologie
- UZ Gent
- CHU Tivoli
- UZ Gasthuisberg Leuven Nierziekten
- CHU Andre VESALE
- RHMS TournayService de néphrologie
- Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
- Hospital JihlavaVrchlického
- Regional Hospital Liberec
- Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
- Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
- Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
- Fresenius Medical Care - DS Prague 4
- Dept. of Internal Medicine StrahovSermirska 5
- Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
- University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
- Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
- Vaszary Kolos HospitalFresenius Dialysis Center
- Petz Aladár Teaching Hospital Vasvári
- Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
- Vas and Szombathely County Markusovszky Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
HB-AS02V vaccine
HBVAXPRO vaccine