Safety and immunogenicity of a new hepatitis B vaccine for the protection of patients with renal insufficiency including pre-haemodialysis and haemodialysis patients

Abstract

Background: High susceptibility to infections including the hepatitis B virus (HBV) causes increased morbidity and mortality in patients with end stage renal disease. HBV vaccination is recommended for all patients undergoing dialysis; however, antibody response is much lower than in healthy individuals. Objective: This review discusses the clinical experience with HBV vaccine with a novel adjuvant system among dialysed patients. Method: A new adjuvanted HBV vaccine (Fendrix^™, GlaxoSmithKline Biologicals, Rixensart, Belgium) contains as active substance 20 μg recombinant hepatitis B surface antigen produced in Saccharomyces cerevisiae and the novel adjuvant system composed of aluminum salt and 3-O-desacyl-4′-monophosphoryl lipid A (AS04). Conclusion: HBV-AS04 vaccine has a good safety profile with clinically acceptable reactions similar to standard HBV vaccines and has elicited earlier antibody response and higher antibody titres in pre and haemodialysis patients as compared with four double doses of standard HBV vaccine.

Keywords::

• haemodialysis
• HBV-AS04 vaccine
• hepatitis B
• immunisation
• immunogenicity
• novel adjuvant
• reactogenicity

Acknowledgements

The author wishes to thank V Delpire and J Beck for their valuable assistance in the preparation of this manuscript, with the support of GlaxoSmithKline Biologicals. Preparing of the manuscript was also partially supported by research grant of University Hospital Hradec Králové, Czech Republic MZO 00179906. The author would also like to thank to M Vejrostova from Galen Publishing for graphical support for Figure 1.

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