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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00291954
• Date of registration: 14/02/2006
• Prospective Registration: Yes
• Primary sponsor: Henogen
• Public title: 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
• Scientific 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
• Date of first enrolment: March 2006
• Target sample size: 257
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00291954
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Belgium, Czech Republic, Hungary

Contacts

• Name: Christian Tielemans, MD, PhD
• Affiliation: ULB Hôpital Erasme Département de Néphrologie

Key inclusion & exclusion 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



Age minimum: 15 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis B

Intervention(s)

Biological: HBVAXPRO vaccine

Biological: HB-AS02V

Primary Outcome(s)

Anti-HBs seroprotection rate [Time Frame: Month 2]

Secondary Outcome(s)

Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2 [Time Frame: Month 0 to 2]

Anti-HBs Seropositivity rates for all subjects. [Time Frame: Months 0, 1 and 2]

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 [Time Frame: Month 0, 1 and 2]

Anti-HBs Geometric Mean Concentrations calculated for all subjects. [Time Frame: Months 0, 1 and 2]

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 [Time Frame: Month 0, 1 and 2]

Anti-HBs Seroprotection rates for all subjects. [Time Frame: Months 0, 1 and 2]

Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects [Time Frame: Months 0, 1 and 2]

Secondary ID(s)

HN017/HBV-003 (105762)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline