Hepatitis B Clinical Trial
Official title:
A Phase III, Multicentric, Multinational, Controlled, Randomised, Open Study Comparing the Immunogenicity, Reactogenicity and Safety of Henogen's New Adjuvanted Hepatitis B Vaccine, HB-AS02V, to That of Aventis Pasteur MSD's Hepatitis B Vaccine, HBVAXPRO® , Administered as a Booster Dose in Pre-Dialysis, Peritoneal Dialysis and Haemodialysis Subjects (³ 15 Years of Age) Who Previously Responded to Hepatitis B Primary Vaccination But Have Lost Antibody.
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.
Status | Completed |
Enrollment | 185 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Belgium | O.L.Vrouwziekenhuis Aalst | Aalst | |
Belgium | RHMS La Madeleine ATH | ATH | |
Belgium | RHMS Clinique Louis Caty Baudour | Baudour | |
Belgium | CHU Brugmann (site V Horta) Service de néphrologie | Bruxelles | |
Belgium | Cliniques universitaires Saint Luc | Bruxelles | |
Belgium | ULB Hôpital Erasme Département de Néphrologie | Bruxelles | |
Belgium | CHU Hôpital civil de | Charleroi | |
Belgium | UZ AntwerpenDienst nefrologie | Edegem | |
Belgium | UZ Gent | Gent | |
Belgium | CHU Tivoli | La Louvière | |
Belgium | UZ Gasthuisberg Leuven Nierziekten | Leuven | |
Belgium | CHU Andre VESALE | Montigny le tilleul | |
Belgium | RHMS TournayService de néphrologie | Tournai | |
Czech Republic | Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska | Hradec Kralove | |
Czech Republic | 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 | Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic | Ostrava - Poruba | |
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 Prague 4 | Prague | |
Czech Republic | Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska | Sokolov | |
Hungary | University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department | Debrecen | |
Hungary | Markhot Ferenc County HospitalFresenius Dialysis Center Baktai | Eger | |
Hungary | Vaszary Kolos HospitalFresenius Dialysis Center | Esztergom | |
Hungary | Petz Aladár Teaching Hospital Vasvári | Gyor | |
Hungary | Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan . | Hatvan | |
Hungary | Vas and Szombathely County Markusovszky Hospital | Szombathely |
Lead Sponsor | Collaborator |
---|---|
Henogen | GlaxoSmithKline |
Belgium, Czech Republic, Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-HBs antibody geometric mean concentrations. | Month 0 and Month 1 | No | |
Secondary | Seroprotection rates for all subjects | Months 0, 1 | No | |
Secondary | Seropositivity rates for all subjects | Month 0 and at Month 1 | No | |
Secondary | Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects | Month 0 and at Month 1 | No | |
Secondary | Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects | Month 0 and Month 1 | No | |
Secondary | 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 | Yes | |
Secondary | 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 | Yes | |
Secondary | Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1 | Month 0 to 1 | Yes |
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