Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination

Hepatitis B Clinical Trial

Official title:

A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1months to That of Aventis Pasteur MSD's Hepatitis B Given at 0, 1 Months in Pre-Dialysis, and Dialysis Patients Did Not Respond to Previous Hepatitis B Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291954
• Other study ID #: HN017/HBV-003 (105762)
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2006
• Last updated: August 27, 2008
• Start date: March 2006
• Est. completion date: October 2007

Study information

• Verified date: August 2008
• Source: Henogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.

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 4 visits and blood samples will taken at each of these visits.

Other known NCT identifiers

• NCT00671762

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion criteria

• A male or female subject greater than or equal to 15 years of age at the time of study entry

• Written informed consent obtained from the subject/ from the parent or guardian of the subject.

• Seronegative for anti-HBc antibodies and for HBsAg at screening.

• Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients

• Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.

• The last dose should have been administered at least two months before the planned first dose of study vaccine in this study.

• Documented evidence of non-response to previous hepatitis B vaccination after at least one to maximum three months after the last vaccine dose.

Exclusion criteria

• Subject included on HN014/HBV-001 study. History of Hepatitis B infection Use of immunoglobulins within six months preceding the first study vaccination.

• Any confirmed or suspected human immunodeficiency virus (HIV) infection. Pregnant or lactating female

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• HB-AS02V
HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
• HBVAXPRO vaccine
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1

Locations

Country	Name	City	State
Belgium	O.L.Vrouwziekenhuis Aalst	Aalst
Belgium	RHMS La Madeleine ATH	ATH
Belgium	RHMS Clinique Louis Caty Baudour	Baudour
Belgium	CHU Brugmann (site V Horta) Service de néphrologie	Bruxelles
Belgium	Cliniques universitaires Saint Luc	Bruxelles
Belgium	ULB Hôpital Erasme Département de Néphrologie	Bruxelles
Belgium	CHU Hôpital civil de	Charleroi
Belgium	UZ AntwerpenDienst nefrologie	Edegem
Belgium	UZ Gent	Gent
Belgium	CHU Tivoli	La Louvière
Belgium	UZ Gasthuisberg Leuven Nierziekten	Leuven
Belgium	CHU Andre VESALE	Montigny le tilleul
Belgium	RHMS TournayService de néphrologie	Tournai
Czech Republic	Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska	Hradec Kralove
Czech Republic	Dept. of Heamodialysis Hospital JihlavaVrchlického	Jihlava
Czech Republic	Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova	Olomouc
Czech Republic	Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic	Ostrava - Poruba
Czech Republic	Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska	Pardubice
Czech Republic	Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska	Sokolov
Hungary	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	Gyor
Hungary	Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .	Hatvan
Hungary	Zala County HospitalII. Medical Department Nephrology Zrinyi	Zalaegerszeg

Sponsors (2)

Lead Sponsor	Collaborator
Henogen	GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs seroprotection rate		Month 2	No
Secondary	Anti-HBs Seroprotection rates for all subjects.		Months 0, 1 and 2	No
Secondary	Anti-HBs Seropositivity rates for all subjects.		Months 0, 1 and 2	No
Secondary	Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects		Months 0, 1 and 2	No
Secondary	Anti-HBs Geometric Mean Concentrations calculated for all subjects.		Months 0, 1 and 2	No
Secondary	Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms reported during the 4-day follow-up period after each vaccination and overall		Month 0, 1 and 2	Yes
Secondary	Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall		Month 0, 1 and 2	Yes
Secondary	Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2		Month 0 to 2	Yes