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.

NCT00291980 | Completed Phase 3

• 1 other identifier: HN018/HBV-004 (105754)
• Study Type: interventional
• Target: 185
• Locations: 3 countries
• Sites: 28

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.

Conditions

Hepatitis B

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Anti-HBs antibody geometric mean concentrations.

  Month 0 and Month 1

Secondary Outcomes (7)

• Seroprotection rates for all subjects

  Months 0, 1

• Seropositivity rates for all subjects

  Month 0 and at Month 1

• Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects

  Month 0 and at Month 1

• Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects

  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

  Month 0

Study Arms (2)

1

EXPERIMENTAL

HB-AS02V vaccine

Biological: HB-AS02V vaccine

2

ACTIVE COMPARATOR

HBVAXPRO vaccine

Biological: HBVAXPRO vaccine

Interventions

HB-AS02V vaccine BIOLOGICAL

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

1

HBVAXPRO vaccine BIOLOGICAL

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

2

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Henogen: lead
• GlaxoSmithKline: collaborator

Study Sites (28)

O.L.Vrouwziekenhuis Aalst

Aalst, 9300, Belgium

Location

RHMS La Madeleine ATH

Ath, 7800, Belgium

Location

RHMS Clinique Louis Caty Baudour

Baudour, 7331, Belgium

Location

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

Location

CHU Brugmann (site V Horta) Service de néphrologie

Brussels, B-1020, Belgium

Location

ULB Hôpital Erasme Département de Néphrologie

Brussels, Belgium

Location

CHU Hôpital civil de

Charleroi, 6000, Belgium

Location

UZ AntwerpenDienst nefrologie

Edegem, B-2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

CHU Tivoli

La Louvière, 7100, Belgium

Location

UZ Gasthuisberg Leuven Nierziekten

Leuven, 3000, Belgium

Location

CHU Andre VESALE

Montigny-le-Tilleul, 6110, Belgium

Location

RHMS TournayService de néphrologie

Tournai, 7500, Belgium

Location

Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska

Hradec Králové, 581500 05, Czechia

Location

Hospital JihlavaVrchlického

Jihlava, 59586 33, Czechia

Location

Regional Hospital Liberec

Liberec, 46063, Czechia

Location

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

Olomouc, 6775 20, Czechia

Location

Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic

Ostrava - Poruba, 1790708 52, Czechia

Location

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

Pardubice, 44532 03, Czechia

Location

Fresenius Medical Care - DS Prague 4

Prague, 142 00, Czechia

Location

Dept. of Internal Medicine StrahovSermirska 5

Prague, 169 00, Czechia

Location

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

Sokolov, 1863356 01, Czechia

Location

University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department

Debrecen, .H-4012, Hungary

Location

Markhot Ferenc County HospitalFresenius Dialysis Center Baktai

Eger, H-3300, Hungary

Location

Vaszary Kolos HospitalFresenius Dialysis Center

Esztergom, H-2500, Hungary

Location

Petz Aladár Teaching Hospital Vasvári

Győr, H-9023, Hungary

Location

Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .

Hatvan, H-3000, Hungary

Location

Vas and Szombathely County Markusovszky Hospital

Szombathely, 9700, Hungary

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Christian Tielemans, MD, PhD

  ULB Hôpital Erasme Département de Néphrologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: March 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 28, 2008

Record last verified: 2008-08

Locations

BE (13); CZ (9); HU (6)