A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.
This study has been completed.
Sponsor:
Henogen
Collaborator:
GlaxoSmithKline
Information provided by:
Henogen
ClinicalTrials.gov Identifier:
NCT00291941
First received: February 14, 2006
Last updated: August 27, 2008
Last verified: August 2008
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Purpose
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Biological: Henogen HBV vaccine Biological: FENDRIX |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive. |
Resource links provided by NLM:
Further study details as provided by Henogen:
Primary Outcome Measures:
- Anti-HBs seroprotection rate at Month 2. [ Time Frame: Month 0 and 2 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Anti-HBs antibody concentrations [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
- Anti-HBs seroprotection rates for all subjects. [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
- Anti-HBs seropositivity rates for all subjects [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
- Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects. [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
- Anti-HBs geometric mean concentrations calculated for all subjects. [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
- Anti-RF-1 seropositivity rates (defined as the percentage of subjects with anti-RF-1 like antibody concentrations superior or equal to 33 EU/ml, the assay cut-off) in a random subset of 50 subjects per group. [ Time Frame: Months 0 and 7 ] [ Designated as safety issue: No ]
- Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group. [ Time Frame: Month 0 and 7 ] [ Designated as safety issue: No ]
- Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms during a 4-day follow-up (i.e. Day 0 to Day 3) after each vaccination and overall. [ Time Frame: Month 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: Yes ]
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall. [ Time Frame: Month 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: Yes ]
- Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7. [ Time Frame: Month 0 to 7 ] [ Designated as safety issue: Yes ]
| Enrollment: | 300 |
| Study Start Date: | February 2006 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Henogen HB vaccine
|
Biological: Henogen HBV vaccine
20µg, Month 0, 2 and 6
|
|
Active Comparator: 2
Fendrix vaccine
|
Biological: FENDRIX
20 µg,Months 0, 1, 2 and 6
|
Detailed Description:
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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/ from the parent or guardian of the subject.
- Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
- Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
- Non-childbearing potential female
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Use of any registered vaccine within 7 days before the first dose of study vaccine.
- Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
- History of hepatitis B infection.
- Known exposure to hepatitis B virus within 6 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 superior or equal to 37.5°C (or 37 °C in Czech Republic).
- Pregnant or lactating female
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291941
Locations
| Belgium | |
| O.L.Vrouwziekenhuis Aalst | |
| Aalst, Belgium, 9300 | |
| RHMS La Madeleine ATH | |
| ATH, Belgium, 7800 | |
| RHMS Clinique Louis Caty Baudour | |
| Baudour, Belgium, 7331 | |
| CHU Brugmann (site V Horta) Service de néphrologie | |
| Bruxelles, Belgium, B-1020 | |
| AZ -VUB Dienst Nefrologie | |
| Bruxelles, Belgium, 1090 | |
| ULB Hôpital Erasme Département de Néphrologie | |
| Bruxelles, Belgium | |
| Cliniques universitaires Saint Luc | |
| Bruxelles, Belgium, 1200 | |
| CHU Hôpital civil de | |
| Charleroi, Belgium, 6000 | |
| UZ AntwerpenDienst nefrologie | |
| Edegem, Belgium, B-2650 | |
| UZ Gent | |
| Gent, Belgium, 9000 | |
| CHU Tivoli | |
| La Louvière, Belgium, 7100 | |
| UZ Gasthuisberg Leuven Nierziekten | |
| Leuven, Belgium, 3000 | |
| CHU Andre VESALE | |
| Montigny le tilleul, Belgium, 6110 | |
| RHMS TournayService de néphrologie | |
| Tournai, Belgium, 7500 | |
| Czech Republic | |
| Dept. of Heamodialysis Hospital JihlavaVrchlického | |
| Jihlava, Czech Republic, 59586 33 | |
| Regional Hospital Liberec | |
| Liberec, Czech Republic, 46063 | |
| Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic | |
| Ostrava - Poruba, Czech Republic, 1790708 52 | |
| Dept. of Internal Medicine StrahovSermirska 5 | |
| Prague, Czech Republic, 169 00 | |
| Masaryk´s Hospital Socialni pece 3316/12A | |
| Usti nad Labem, Czech Republic, 401 13 | |
| Hungary | |
| St. Rókus Hospital | |
| Budapest, Hungary, 1085 | |
| St. István Hospital | |
| Budapest, Hungary, 1096 | |
| Petz Aladár Teaching Hospital Vasvári | |
| Győr, Hungary, H-9023 | |
| Pest County Flór Ferenc Hospital | |
| Kistarcsa, Hungary, 2143 | |
| Vas and Szombathely County Markusovszky Hospital | |
| Szombathely, Hungary, 9700 | |
Sponsors and Collaborators
Henogen
GlaxoSmithKline
Investigators
| Principal Investigator: | Christian Tielemans, MD, PhD | ULB Hôpital Erasme Département de Néphrologie |
More Information
No publications provided
| Responsible Party: | Sophie Houard CSO, Henogen |
| ClinicalTrials.gov Identifier: | NCT00291941 History of Changes |
| Obsolete Identifiers: | NCT00739726 |
| Other Study ID Numbers: | HN014/HBV-001 (105757) |
| Study First Received: | February 14, 2006 |
| Last Updated: | August 27, 2008 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Henogen:
|
Dialysis Pre-dialysis Hepatitis B vaccine Prophylaxis |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 19, 2013