Oral Smallpox Vaccine Development

描述（由申请人提供）：这一第一阶段SBIR赠款申请积极的目标是在开发INCELL的口服天花疫苗的下一步。它以成功的初步研究为基础，开发原材料，并进行体外和配方研究，作为成功用口服疫苗免疫家兔和绵羊的前奏。其目的是继续开发一种安全、易于管理、价格合理、开发迅速、保质期长的口服天花疫苗。该项目有三个具体目标：（1）进行动物效力研究，以表明口服免疫动物可以免受强毒痘病毒的攻击;（2）改进疫苗生产并寻求监管批准，以包括验证方法和定义SOP，以扩增细胞培养物，浓缩和重新悬浮病毒，并验证病毒-赋形剂-佐剂口服制剂以确保安全性，最终产品的功效和效力;以及（3）为第一次临床试验做准备，该试验将是在人类受试者中进行的口服疫苗的I/II期研究。实现每一具体目标的方法如下。第二阶段将继续努力获得许可的疫苗产品，并将包括临床试验。

DESCRIPTION (provided by applicant): This Phase I SBIR grant application aggressively targets the next steps in the development of lNCELL's oral smallpox vaccine. It builds on successful preliminary studies to develop the raw materials and do in vitro and formulation studies as a prelude to successfully immunizing rabbits and sheep with the oral vaccine. The intent is to continue development of an oral smallpox vaccine that will be safe, easily administered, reasonably priced, rapidly developed, and have a long shelf life. The project has three Specific Aims: (1) Perform animal efficacy studies to show that orally immunized animals can be protected from challenge with a virulent poxvirus; (2) Refine Vaccine Manufacturing and Seek Regulatory Approvals to include validating methods and defining SOPs to expand the cell cultures, concentrate and re-suspend the virus, and validate the virus-excipient-adjuvant oral formulation to assure safety, efficacy and potency of the final product; and (3) Prepare for the First Clinical Trial that will be a Phase I/II study of the oral vaccine in human subjects. The Approaches to each Specific Aim are delineated below. Phase II will be continuing work toward obtaining a licensed vaccine product and will include the clinical trials.