Progress toward a heat- and freeze-stable hepatitis B vaccine

In partnership with Arecor and the University of Colorado Denver School of Pharmacy, PATH published findings in this month’s issue of Human Vaccines (volume 5, issue 8) that describe a new hepatitis B vaccine formulation exhibiting nine week stability at 55°C and at least six month stability at both 37°C and 45°C. The data indicate that the new hepatitis B vaccine formulation will be better able to withstand disruption in the cold chain and could potentially be stored at controlled room temperature for a significant part of its shelf life. Additionally, PATH scientists and partners combined the heat-stable hepatitis B vaccine formulation with the freeze-protection technology developed earlier this year. In collaboration with Arecor and the University of Colorado Denver School of Pharmacy, PATH tested this new hepatitis B vaccine formulation and found it to be heat-stable for 12 months at 37°C in addition to proving freeze-stable at −20°C. According to research findings recently published in Vaccine (volume 27, issue 34), this freeze- and heat-stable formulation was found to be well tolerated in animal models without any significant local or systemic side effects. To date, PATH and collaborators have completed additional laboratory and preclinical studies validating the science and technology behind the new heat- and freeze-stable hepatitis B vaccine formulations. A commercial vaccine producer is in the process of applying the formulation methods to the development of a second-generation hepatitis B vaccine. Key clinical trials of this new product are scheduled for early 2010. The development of these formulation methods and the research described in both published studies were conducted in conjunction with PATH’s broad project work in vaccine stabilization, funded by the Bill & Melinda Gates Foundation.