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.

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Henogen
ClinicalTrials.gov Identifier:
NCT00291980
First received: February 14, 2006
Last updated: August 27, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Hepatitis B
Biological: HB-AS02V vaccine
Biological: HBVAXPRO vaccine
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 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.

Resource links provided by NLM:


Further study details as provided by Henogen:

Primary Outcome Measures:
  • Anti-HBs antibody geometric mean concentrations. [ Time Frame: Month 0 and Month 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroprotection rates for all subjects [ Time Frame: Months 0, 1 ] [ Designated as safety issue: No ]
  • Seropositivity rates for all subjects [ Time Frame: Month 0 and at Month 1 ] [ Designated as safety issue: No ]
  • Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects [ Time Frame: Month 0 and at Month 1 ] [ Designated as safety issue: No ]
  • Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects [ Time Frame: Month 0 and Month 1 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1 [ Time Frame: Month 0 to 1 ] [ Designated as safety issue: Yes ]

Enrollment: 185
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HB-AS02V vaccine
Biological: HB-AS02V vaccine
HB-AS02V (20µg HBsAg) will be administered at Month 0
Active Comparator: 2
HBVAXPRO vaccine
Biological: HBVAXPRO vaccine
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291980

Locations
Belgium
O.L.Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
RHMS La Madeleine ATH
ATH, Belgium, 7800
RHMS Clinique Louis Caty Baudour
Baudour, Belgium, 7331
Cliniques universitaires Saint Luc
Bruxelles, Belgium, 1200
ULB Hôpital Erasme Département de Néphrologie
Bruxelles, Belgium
CHU Brugmann (site V Horta) Service de néphrologie
Bruxelles, Belgium, B-1020
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
Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
Hradec Kralove, Czech Republic, 581500 05
Hospital JihlavaVrchlického
Jihlava, Czech Republic, 59586 33
Regional Hospital Liberec
Liberec, Czech Republic, 46063
Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
Olomouc, Czech Republic, 6775 20
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
Ostrava - Poruba, Czech Republic, 1790708 52
Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
Pardubice, Czech Republic, 44532 03
Fresenius Medical Care - DS Prague 4
Prague, Czech Republic, 142 00
Dept. of Internal Medicine StrahovSermirska 5
Prague, Czech Republic, 169 00
Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
Sokolov, Czech Republic, 1863356 01
Hungary
University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
Debrecen, Hungary, .H-4012
Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
Eger, Hungary, H-3300
Vaszary Kolos HospitalFresenius Dialysis Center
Esztergom, Hungary, H-2500
Petz Aladár Teaching Hospital Vasvári
Győr, Hungary, H-9023
Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
Hatvan, Hungary, H-3000
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: NCT00291980     History of Changes
Obsolete Identifiers: NCT00739804
Other Study ID Numbers: HN018/HBV-004 (105754)
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 hepatitis B infection

Additional relevant MeSH terms:
Hepatitis B
Hepatitis
Hepatitis A
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 July 23, 2014