Clinical trial NCT00291954: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Dialysis
Pre-dialysis
Hepatitis B vaccine
Prophylaxis hepatitis B infection
Lead sponsor: Henogen
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2006-02-15
Enrollment: 257
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Anti-HBs seroprotection rate
timeFrame: Month 2
Secondary outcomes:
measure: Anti-HBs Seroprotection rates for all subjects.
timeFrame: Months 0, 1 and 2
measure: Anti-HBs Seropositivity rates for all subjects.
timeFrame: Months 0, 1 and 2
measure: Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects
timeFrame: Months 0, 1 and 2
measure: Anti-HBs Geometric Mean Concentrations calculated for all subjects.
timeFrame: Months 0, 1 and 2
measure: 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
timeFrame: Month 0, 1 and 2
measure: 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
timeFrame: Month 0, 1 and 2
measure: Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2
timeFrame: Month 0 to 2
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: O.L.Vrouwziekenhuis Aalst
city: ATH
country: Belgium
facility: RHMS La Madeleine ATH
city: Baudour
country: Belgium
facility: RHMS Clinique Louis Caty Baudour
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint Luc
city: Bruxelles
country: Belgium
facility: CHU Brugmann (site V Horta) Service de néphrologie
city: Bruxelles
country: Belgium
facility: ULB Hôpital Erasme Département de Néphrologie
city: Charleroi
country: Belgium
facility: CHU Hôpital civil de
city: Edegem
country: Belgium
facility: UZ AntwerpenDienst nefrologie
city: Gent
country: Belgium
facility: UZ Gent
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven Nierziekten
city: Montigny le tilleul
country: Belgium
facility: CHU Andre VESALE
city: Tournai
country: Belgium
facility: RHMS TournayService de néphrologie
city: Hradec Kralove
country: Czech Republic
facility: Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
city: Jihlava
country: Czech Republic
facility: Dept. of Heamodialysis Hospital JihlavaVrchlického
city: Olomouc
country: Czech Republic
facility: Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
city: Ostrava - Poruba
country: Czech Republic
facility: Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
city: Pardubice
country: Czech Republic
facility: Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
city: Sokolov
country: Czech Republic
facility: Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
city: Debrecen
country: Hungary
facility: University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
city: Eger
country: Hungary
facility: Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
city: Esztergom
country: Hungary
facility: Vaszary Kolos HospitalFresenius Dialysis Center
city: Győr
country: Hungary
facility: Petz Aladár Teaching Hospital Vasvári
city: Hatvan
country: Hungary
facility: Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
city: Zalaegerszeg
country: Hungary
facility: Zala County HospitalII. Medical Department Nephrology Zrinyi
Study officials:
affiliation: ULB Hôpital Erasme Département de Néphrologie
name: Christian Tielemans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: