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.

NCT ID: NCT00291980

Last Updated: 2008-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-10-31

Brief Summary

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.

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.

Conditions

Hepatitis B

Keywords

Dialysis; Pre-dialysis; Hepatitis B vaccine; Prophylaxis hepatitis B infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

HB-AS02V vaccine

Group Type: EXPERIMENTAL

HB-AS02V vaccine

Intervention Type: BIOLOGICAL

HB-AS02V (20µg HBsAg) will be administered at Month 0

2

HBVAXPRO vaccine

Group Type: ACTIVE_COMPARATOR

HBVAXPRO vaccine

Intervention Type: BIOLOGICAL

HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0

Interventions

HB-AS02V vaccine

HB-AS02V (20µg HBsAg) will be administered at Month 0

Intervention Type: BIOLOGICAL

HBVAXPRO vaccine

HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Henogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Henogen

Principal Investigators

Christian Tielemans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ULB Hôpital Erasme Département de Néphrologie

Locations

O.L.Vrouwziekenhuis Aalst

Aalst, , Belgium

RHMS La Madeleine ATH

Ath, , Belgium

RHMS Clinique Louis Caty Baudour

Baudour, , Belgium

Cliniques universitaires Saint Luc

Brussels, , Belgium

CHU Brugmann (site V Horta) Service de néphrologie

Brussels, , Belgium

ULB Hôpital Erasme Département de Néphrologie

Brussels, , Belgium

CHU Hôpital civil de

Charleroi, , Belgium

UZ AntwerpenDienst nefrologie

Edegem, , Belgium

UZ Gent

Ghent, , Belgium

CHU Tivoli

La Louvière, , Belgium

UZ Gasthuisberg Leuven Nierziekten

Leuven, , Belgium

CHU Andre VESALE

Montigny-le-Tilleul, , Belgium

RHMS TournayService de néphrologie

Tournai, , Belgium

Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska

Hradec Králové, , Czechia

Hospital JihlavaVrchlického

Jihlava, , Czechia

Regional Hospital Liberec

Liberec, , Czechia

Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova

Olomouc, , Czechia

Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic

Ostrava - Poruba, , Czechia

Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska

Pardubice, , Czechia

Fresenius Medical Care - DS Prague 4

Prague, , Czechia

Dept. of Internal Medicine StrahovSermirska 5

Prague, , Czechia

Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska

Sokolov, , Czechia

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

Győr, , Hungary

Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .

Hatvan, , Hungary

Vas and Szombathely County Markusovszky Hospital

Szombathely, , Hungary

Countries

Belgium; Czechia; Hungary

Other Identifiers

HN018/HBV-004 (105754)

Identifier Type: -

Identifier Source: org_study_id

NCT00739804

Identifier Type: -

Identifier Source: nct_alias