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.

August 27, 2008 updated by: Henogen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • ATH, Belgium, 7800
        • RHMS La Madeleine ATH
      • Aalst, Belgium, 9300
        • O.L.Vrouwziekenhuis Aalst
      • Baudour, Belgium, 7331
        • RHMS Clinique Louis Caty Baudour
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Bruxelles, Belgium, B-1020
        • CHU Brugmann (site V Horta) Service de néphrologie
      • Bruxelles, Belgium
        • ULB Hôpital Erasme Département de Néphrologie
      • Charleroi, Belgium, 6000
        • CHU Hôpital civil de
      • Edegem, Belgium, B-2650
        • UZ AntwerpenDienst nefrologie
      • Gent, Belgium, 9000
        • UZ Gent
      • La Louvière, Belgium, 7100
        • CHU Tivoli
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg Leuven Nierziekten
      • Montigny le tilleul, Belgium, 6110
        • CHU Andre VESALE
      • Tournai, Belgium, 7500
        • RHMS TournayService de néphrologie
  • Czech Republic
      • Hradec Kralove, Czech Republic, 581500 05
        • Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
      • Jihlava, Czech Republic, 59586 33
        • Hospital JihlavaVrchlického
      • Liberec, Czech Republic, 46063
        • Regional Hospital Liberec
      • Olomouc, Czech Republic, 6775 20
        • Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
      • Ostrava - Poruba, Czech Republic, 1790708 52
        • Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
      • Pardubice, Czech Republic, 44532 03
        • Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
      • Prague, Czech Republic, 142 00
        • Fresenius Medical Care - DS Prague 4
      • Prague, Czech Republic, 169 00
        • Dept. of Internal Medicine StrahovSermirska 5
      • Sokolov, Czech Republic, 1863356 01
        • Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
  • Hungary
      • Debrecen, Hungary, .H-4012
        • University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
      • Eger, Hungary, H-3300
        • Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
      • Esztergom, Hungary, H-2500
        • Vaszary Kolos HospitalFresenius Dialysis Center
      • Győr, Hungary, H-9023
        • Petz Aladár Teaching Hospital Vasvári
      • Hatvan, Hungary, H-3000
        • Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
      • Szombathely, Hungary, 9700
        • Vas and Szombathely County Markusovszky Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs antibody geometric mean concentrations.
Time Frame: Month 0 and Month 1
Month 0 and Month 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Seroprotection rates for all subjects
Time Frame: Months 0, 1
Months 0, 1
Seropositivity rates for all subjects
Time Frame: Month 0 and at Month 1
Month 0 and at Month 1
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
Month 0 and at Month 1
Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects
Time Frame: Month 0 and Month 1
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
Time Frame: Month 0
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
Time Frame: Month 0
Month 0
Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1
Time Frame: Month 0 to 1
Month 0 to 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henogen

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Christian Tielemans, MD, PhD, ULB Hôpital Erasme Département de Néphrologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (Estimate)

February 15, 2006

Study Record Updates

Last Update Posted (Estimate)

August 28, 2008

Last Update Submitted That Met QC Criteria

August 27, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN018/HBV-004 (105754)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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