Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™
- Conditions
- Hepatitis B
- Registration Number
- NCT00445185
- Lead Sponsor
- Henogen
- Brief Summary
The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives \& outcome measures of the extension phase at Months 12, 24 and 36. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).
- Detailed Description
Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
- Subjects who completed the full course of primary vaccination.
- Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
- Any confirmed or suspected human immunodeficiency virus (HIV) infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-HBs antibody concentrations Months 12, 24 and 36.
- Secondary Outcome Measures
Name Time Method Quality of immune response Month 12, 24 and 36 SAEs retrospective reporting Month 12, 24 and 36 RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001). Month 12, 24 and 36
Trial Locations
- Locations (23)
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
ULB Hôpital Erasme Département de Néphrologie
🇧🇪Bruxelles, Belgium
AZ -VUB Dienst Nefrologie
🇧🇪Bruxelles, Belgium
Cliniques universitaires Saint Luc
🇧🇪Bruxelles, Belgium
CHU Hôpital civil de
🇧🇪Charleroi, Belgium
UZ Gent
🇧🇪Gent, Belgium
CHU Tivoli
🇧🇪La Louvière, Belgium
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