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Research Paper

A heat-stable hepatitis B vaccine formulation

Jan Jezek, Dexiang Chen, Lynne Watson, Jill Crawford, Shalimar Perkins, Anil Tyagi and LaToya Jones Braun

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The purpose of the present study was to develop a formulation of recombinant hepatitis B vaccine with improved stability at elevated temperatures. A validated, in vitro, antigen reactivity assay was used to measure the stability of the vaccine. The formulation development focused on modification of the interactions between the antigen and aluminum hydroxide adjuvant and subsequent optimization of the ionic aqueous environment of the adsorbed vaccine. A formulation of hepatitis B vaccine containing 40 mM histidine and 40 mM phosphate at pH 5.2 had considerably improved stability at elevated temperatures as measured by the in vitro antigen reactivity assay. The formulation exhibited 9-week stability at 55°C and was subsequently shown to be stable both at 37°C and at 45°C for at least 6 months based on the in vitro antigen reactivity and immunogenicity in mice. The formulation comprises only excipients which have a history of safe use in approved drug products. The new vaccine formulation has the potential to be used outside the cold chain for part of its shelf life. This may improve the immunization coverage, simplify the logistics for outreach immunization, and ensure the potency of the vaccine in areas where the cold chain is insufficient.

Authors

Jan Jezek Corresponding author: jan.jezek@arecor.com

Arecor Limited, Sharnbrook, Bedfordshire, UK

Dexiang Chen

PATH; Seattle, Washington USA

Lynne Watson

Arecor Limited, Sharnbrook, Bedfordshire, UK

Jill Crawford

Arecor Limited, Sharnbrook, Bedfordshire, UK

Shalimar Perkins

PATH; Seattle, Washington USA

Anil Tyagi

University of Colorado Denver; School of Pharmacy; Department of Pharmaceutical Science; Denver, Colorado USA

LaToya Jones Braun

University of Colorado Denver; School of Pharmacy; Department of Pharmaceutical Science; Denver, Colorado USA

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