Clinical trial NCT00291980: 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.
Official title: 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.
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: 185
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: 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.

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

Primary outcomes:
measure: Anti-HBs antibody geometric mean concentrations.
timeFrame: Month 0 and Month 1
Secondary outcomes:
measure: Seroprotection rates for all subjects
timeFrame: Months 0, 1
measure: Seropositivity rates for all subjects
timeFrame: Month 0 and at Month 1
measure: Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects
timeFrame: Month 0 and at Month 1
measure: Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects
timeFrame: Month 0 and Month 1
measure: 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
timeFrame: Month 0
measure: 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
timeFrame: Month 0
measure: Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1
timeFrame: Month 0 to 1
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: Hospital JihlavaVrchlického
city: Liberec
country: Czech Republic
facility: Regional Hospital Liberec
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: Prague
country: Czech Republic
facility: Fresenius Medical Care - DS Prague 4
city: Prague
country: Czech Republic
facility: Dept. of Internal Medicine StrahovSermirska 5
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: Szombathely
country: Hungary
facility: Vas and Szombathely County Markusovszky Hospital
Study officials:
affiliation: ULB Hôpital Erasme Département de Néphrologie
name: Christian Tielemans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: