A new, rapidly dissolving and thermally stable dry powder Hepatitis-B vaccine

描述（由申请人提供）：该项目的总体目标是将一种新的乙型肝炎疫苗干粉配方推向商业化。在I期SBIR中，我们在体外测试了市售的Shanvac-B的三种乙肝干粉配方，并在-20 ？C到65℃。在这些极端温度下，目前上市的乙型肝炎液体疫苗由于HBsAg抗原从明矾佐剂中分离而失活。我们的研究还表明，干燥的微尺度粉末溶解得非常快，这表明它们在单剂量自动重构装置中用于肠外给药。这些结果对疫苗的储存、运输和管理具有深远的影响，特别是在

DESCRIPTION (provided by applicant): The overarching goal of this project is to move a new, dry powder formulation of Hepatitis-B vaccine on its path to commercialization. In the Phase I SBIR we tested in vitro three Hep-B dry powder formulations of commercially available Shanvac-B and demonstrated powder stability and immunogenicity at temperatures ranging from -20 ?C through 65 oC. At these temperature extremes the currently marketed liquid Hepatis B vaccine is inactivated as the HBsAg antigen separates from the alum adjuvant. Our studies also showed that the dry micro-scale powders dissolved very rapidly, suggesting their utility in single dose auto-reconstitution devices aimed at parenteral administration. These results have far-reaching implications in regard to vaccine storage, transport and administration, especially in developing countries where limited refrigeration and electric power and high ambient temperatures restrict the useful life and potency of liquid vaccines. In the proposed Phase II SBIR study, we will choose the "optimum" formulation from the three that we developed earlier and pair this powder with a single dose auto-reconstitution device being developed by Becton Dickinson (BD). The drug- device combination will be used to assess potency in a mouse model compared to a control group of animals that will be administered Shanvac-B by needle and syringe. Potency will be assessed from ELISA analysis of animal sera. . The outcome of the Phase II work will be judged based on the potency of the Hep-B dry powder formulation and the functionality and performance of the BD device as compared with the potency of the needle and syringe administration.