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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.

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HB-AS02V vaccine
HBVAXPRO vaccine
Sponsored by
Henogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis hepatitis B infection

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • O.L.Vrouwziekenhuis Aalst
  • RHMS La Madeleine ATH
  • RHMS Clinique Louis Caty Baudour
  • Cliniques universitaires Saint Luc
  • CHU Brugmann (site V Horta) Service de néphrologie
  • ULB Hôpital Erasme Département de Néphrologie
  • CHU Hôpital civil de
  • UZ AntwerpenDienst nefrologie
  • UZ Gent
  • CHU Tivoli
  • UZ Gasthuisberg Leuven Nierziekten
  • CHU Andre VESALE
  • RHMS TournayService de néphrologie
  • Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
  • Hospital JihlavaVrchlického
  • Regional Hospital Liberec
  • Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
  • Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
  • Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
  • Fresenius Medical Care - DS Prague 4
  • Dept. of Internal Medicine StrahovSermirska 5
  • Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
  • University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
  • Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
  • Vaszary Kolos HospitalFresenius Dialysis Center
  • Petz Aladár Teaching Hospital Vasvári
  • Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
  • Vas and Szombathely County Markusovszky Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

HB-AS02V vaccine

HBVAXPRO vaccine

Outcomes

Primary Outcome Measures

Anti-HBs antibody geometric mean concentrations.

Secondary Outcome Measures

Seroprotection rates for all subjects
Seropositivity rates for all subjects
Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects
Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects
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
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
Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1

Full Information

First Posted
February 14, 2006
Last Updated
August 27, 2008
Sponsor
Henogen
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00291980
Brief Title
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

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Henogen
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis hepatitis B infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
HB-AS02V vaccine
Arm Title
2
Arm Type
Active Comparator
Arm Description
HBVAXPRO vaccine
Intervention Type
Biological
Intervention Name(s)
HB-AS02V vaccine
Intervention Description
HB-AS02V (20µg HBsAg) will be administered at Month 0
Intervention Type
Biological
Intervention Name(s)
HBVAXPRO vaccine
Intervention Description
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0
Primary Outcome Measure Information:
Title
Anti-HBs antibody geometric mean concentrations.
Time Frame
Month 0 and Month 1
Secondary Outcome Measure Information:
Title
Seroprotection rates for all subjects
Time Frame
Months 0, 1
Title
Seropositivity rates for all subjects
Time Frame
Month 0 and at Month 1
Title
Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects
Time Frame
Month 0 and at Month 1
Title
Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects
Time Frame
Month 0 and Month 1
Title
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
Time Frame
Month 0
Title
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
Time Frame
Month 0
Title
Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1
Time Frame
Month 0 to 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Tielemans, MD, PhD
Organizational Affiliation
ULB Hôpital Erasme Département de Néphrologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
O.L.Vrouwziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
RHMS La Madeleine ATH
City
ATH
ZIP/Postal Code
7800
Country
Belgium
Facility Name
RHMS Clinique Louis Caty Baudour
City
Baudour
ZIP/Postal Code
7331
Country
Belgium
Facility Name
Cliniques universitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU Brugmann (site V Horta) Service de néphrologie
City
Bruxelles
ZIP/Postal Code
B-1020
Country
Belgium
Facility Name
ULB Hôpital Erasme Département de Néphrologie
City
Bruxelles
Country
Belgium
Facility Name
CHU Hôpital civil de
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ AntwerpenDienst nefrologie
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Gasthuisberg Leuven Nierziekten
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Andre VESALE
City
Montigny le tilleul
ZIP/Postal Code
6110
Country
Belgium
Facility Name
RHMS TournayService de néphrologie
City
Tournai
ZIP/Postal Code
7500
Country
Belgium
Facility Name
Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
City
Hradec Kralove
ZIP/Postal Code
581500 05
Country
Czech Republic
Facility Name
Hospital JihlavaVrchlického
City
Jihlava
ZIP/Postal Code
59586 33
Country
Czech Republic
Facility Name
Regional Hospital Liberec
City
Liberec
ZIP/Postal Code
46063
Country
Czech Republic
Facility Name
Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
City
Olomouc
ZIP/Postal Code
6775 20
Country
Czech Republic
Facility Name
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
City
Ostrava - Poruba
ZIP/Postal Code
1790708 52
Country
Czech Republic
Facility Name
Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
City
Pardubice
ZIP/Postal Code
44532 03
Country
Czech Republic
Facility Name
Fresenius Medical Care - DS Prague 4
City
Prague
ZIP/Postal Code
142 00
Country
Czech Republic
Facility Name
Dept. of Internal Medicine StrahovSermirska 5
City
Prague
ZIP/Postal Code
169 00
Country
Czech Republic
Facility Name
Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
City
Sokolov
ZIP/Postal Code
1863356 01
Country
Czech Republic
Facility Name
University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
City
Debrecen
ZIP/Postal Code
.H-4012
Country
Hungary
Facility Name
Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
City
Eger
ZIP/Postal Code
H-3300
Country
Hungary
Facility Name
Vaszary Kolos HospitalFresenius Dialysis Center
City
Esztergom
ZIP/Postal Code
H-2500
Country
Hungary
Facility Name
Petz Aladár Teaching Hospital Vasvári
City
Győr
ZIP/Postal Code
H-9023
Country
Hungary
Facility Name
Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
City
Hatvan
ZIP/Postal Code
H-3000
Country
Hungary
Facility Name
Vas and Szombathely County Markusovszky Hospital
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

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.

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