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2008/9 Catalogue
Library Recommendation
Summary
April 2007, Vol. 6, No. 2, Pages 133-140 , DOI 10.1586/14760584.6.2.133
(doi:10.1586/14760584.6.2.133)

Vaccine Profile
New hepatitis B vaccine formulated with an improved adjuvant system
Michael Kundi



A new hepatitis B vaccine (FENDrix™, GlaxoSmithKline Biologicals) containing as active substance 20 µg of recombinant hepatitis B virus surface antigen produced in Saccharomyces cerevisiae has recently been licensed in Europe. It is prepared with a novel adjuvant system: aluminum phosphate and 3-O-desacyl-4´-monophosphoryl lipid A. It is intended for use in adults from the age of 15 years onwards for active immunization against hepatitis B virus infection for patients with renal insufficiency (including prehemodialysis and hemodialysis patients). It is applied in a four-dose scheme: day 0, month 1, 2 and 6 after day 0. Due to the improved adjuvant system it induces higher antibody concentrations that reach protective levels in a faster fashion. Furthermore, due to higher titers reached after the primary immunization course, protective levels are retained for a longer period of time. Vaccination with FENDrix induces more transient local symptoms, with pain at the injection site being the most frequently reported solicited local symptom. Other symptoms such as fatigue, gastrointestinal disorders and headaches were also frequently observed but resolved without sequelae. The higher risk of hepatitis B transmission in patients with end-stage renal disease and the often immunocompromised status of these patients afford a tailored vaccination strategy that, up to now, has consisted of injecting double doses of ordinary hepatitis B vaccines. With the introduction of FENDrix there now exists an efficient alternative with superior immunogenicity that is, despite comparatively higher reactogenicity, well tolerated.

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Barbara C. Baudner, Vanessa Ronconi, Daniele Casini, Marco Tortoli, Jina Kazzaz, Manmohan Singh, Lynn D. Hawkins, Andreas Wack, Derek T. O’Hagan. (2009) MF59 Emulsion Is an Effective Delivery System for a Synthetic TLR4 Agonist (E6020). Pharmaceutical Research 26:6, 1477-1485
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Jiri Beran. (2008) Safety and immunogenicity of a new hepatitis B vaccine for the protection of patients with renal insufficiency including pre-haemodialysis and haemodialysis patients. Expert Opinion on Biological Therapy 8:2, 235-247
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IanH. Frazer, DougR. Lowy, JohnT. Schiller. (2007) Prevention of cancer through immunization: Prospects and challenges for the 21st century. European Journal of Immunology 37:S1, S148-S155
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Nathalie Garçon, Patrick Chomez, Marcelle Van Mechelen. (2007) GlaxoSmithKline Adjuvant Systems in vaccines: concepts, achievements and perspectives. Expert Review of Vaccines 6:5, 723-739
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Allison Chamberlain, Gigi Kwik Gronvall. (2007) Immune-Boosting Adjuvants. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 5:3, 202-205
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Clint S Schmidt, W John W Morrow, Nadeem A Sheikh. (2007) Smart adjuvants. Expert Review of Vaccines 6:3, 391-400
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Author:
Michael Kundi
Keywords:
end-stage renal disease
hemodialysis
hepatitis B vaccine
lipid A


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