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Expert Opin Ther Pat. 2009 Jan;19(1):59-72. doi: 10.1517/13543770802587226.

A review of multiple approaches towards an improved hepatitis B vaccine.

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Infection Discovery, AstraZeneca R&D Boston, 35 Gatehouse Drive, Waltham, MA 02451, USA.



Hepatitis B is a DNA virus that can cause liver inflammation, cirrhosis, and cancer in chronically infected and symptomatic carriers. Antiviral treatments are usually limited in their effectiveness in treating the disease states. Vaccination against hepatitis B in pediatric and adolescent populations has proven to be a generally effective means for preventing diseases that could be potentially caused by this virus. Some 5 - 10% of the vaccinees do not develop protective immunity against the virus. Therefore, a significant amount of effort has been made in many research laboratories across the world to increase the potency of the vaccine by various innovative means, e.g., increasing the immunogenicity of the antigen or through introduction of novel adjuvants that elicit strong humoral and cell-mediated immune responses.


The objective of this review is to highlight publications of significant developments that have been made over the past decade and efforts that are continuing towards producing an improved vaccine. A number of patents that protect novel hepatitis B vaccine formulations, including those claiming novel hepatitis B core antigen formulations and combinations of a vaccine with small molecule therapeutics, are discussed.


There have been promising developments in the area of new adjuvants and delivery systems. The practical need for reducing the total number of childhood vaccinations has driven development of, and patent filings on, multivalent and combination vaccine formulations in which the hepatitis B vaccine is included as one component. Efforts and some advances have also been made in the critical area of therapeutic application of the vaccine. The existence of a large population of already infected patients and the inadequacy of most of the current antiviral drugs against hepatitis B diseases have also inspired efforts to produce a vaccine that would be efficacious in clearing an exiting infection.

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