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.

Hepatitis B Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291980
• Other study ID #: HN018/HBV-004 (105754)
• 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

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.

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.

Other known NCT identifiers

• NCT00739804

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• 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:

• 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

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

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	Hospital JihlavaVrchlického	Jihlava
Czech Republic	Regional Hospital Liberec	Liberec
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	Dept. of Internal Medicine StrahovSermirska 5	Prague
Czech Republic	Fresenius Medical Care - DS Prague 4	Prague
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	Vas and Szombathely County Markusovszky Hospital	Szombathely

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 antibody geometric mean concentrations.		Month 0 and Month 1	No
Secondary	Seroprotection rates for all subjects		Months 0, 1	No
Secondary	Seropositivity rates for all subjects		Month 0 and at Month 1	No
Secondary	Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects		Month 0 and at Month 1	No
Secondary	Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects		Month 0 and Month 1	No
Secondary	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	Yes
Secondary	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		Month 0	Yes
Secondary	Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1		Month 0 to 1	Yes