Oral Smallpox Vaccine Development

口服天花疫苗的开发

• 批准号: 6736995
• 负责人: MARY PAT MOYER
• 金额: $ 42.83万
• 依托单位: INCELL CORPORATION, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2005-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6736995
• 关键词: Poxviridae disease; active immunization; drug design /synthesis /production; enzyme linked immunosorbent assay; immune response; immunologic assay /test; laboratory rabbit; neutralizing antibody; oral administration; polymerase chain reaction; sheep; smallpox vaccine; vaccine development; vaccine evaluation; virulence

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.

描述（由申请人提供）：这项I期SBIR拨款申请积极针对lNCELL口服天花疫苗开发的下一步。它建立在成功的初步研究的基础上，开发原材料，并进行体外和配方研究，作为成功地用口服疫苗免疫兔子和羊的前奏。其目的是继续开发一种口服天花疫苗，这种疫苗将安全、易于施用、价格合理、开发迅速并具有较长的保质期。该项目有三个具体目标：(1)进行动物功效研究，以证明口服免疫的动物可以免受强毒性痘病毒的攻击；(2)完善疫苗生产并寻求监管部门批准，包括验证方法和定义标准操作程序，以扩大细胞培养，浓缩和重新悬浮病毒，并验证病毒-赋形剂-佐剂口服配方，以确保最终产品的安全性、有效性和效力；(3)准备首次临床试验，这将是口服疫苗在人类受试者中的I/II期研究。实现每个具体目标的方法如下所述。第二阶段将继续致力于获得许可的疫苗产品，并将包括临床试验。