Pharma Focus Asia

Heat Stable Hepatitis B vaccine

Partner

Since 2006, Arecor has collaborated with PATH, an international global health nonprofit organisation, on the development of heat stable vaccines using the ArestatT technology. Stabilisation of hepatitis B vaccine - one of the many vaccines successfully stabilised in partnership with PATH - was undertaken to support broader efforts to expand hepatitis B vaccination coverage in developing countries, especially in remote settings that are beyond the margins of the vaccine cold chain

Challenge

All currently marketed vaccines are heat sensitive and require a cold chain for transportation and storage. Our study with one brand of hepatitis B vaccine showed a loss of 50% of potency after 1 month at 37?C, or after 3 days at 45?C. Improved stability at elevated temperatures would facilitate the use of the vaccine outside the cold chain, potentially expanding immunisation coverage by simplifying the logistics for immunisation outreach and ensuring vaccine potency in areas where the cold chain is insufficient.

ArestatT solution An existing marketed hepatitis B vaccine product was reformulated based on the principles of the ArestatT technology and showed >70% in vitro potency after 12 months at 37?C. In contrast, the potency of the marketed product decreased rapidly and was almost completely lost after 12 months incubation at 37?C. The ArestatT formulation allows a control of micro-pH environment and proton exchange at the surface of the aluminium hydroxide adjuvant with beneficial effects on its stability.

Jezek et al. A heat-stable hepatitis B vaccine formulation. Human Vaccines (2009), 5(8), 529-35. Antigenic activity of hepatitis B vaccine following incubation at 37?C. Measured by validated AUSZYME test. Control = existing marketed Hepatitis B product (Shanvac-B); Stable liquid = ArestatT formulation

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