Smallpox subunit vaccine in the C-PERL expression system

C-PERL 表达系统中的天花亚单位疫苗

• 批准号: 7008794
• 负责人: George Buchman
• 金额: $ 411.84万
• 依托单位: CHESAPEAKE PERL
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7008794
• 关键词: Smallpox; subunit; vaccine; PERL; expression

DESCRIPTION (provided by applicant): Chesapeake PERL (C-PERL), a recombinant protein manufacturing company, proposes to develop a smallpox vaccine based on recombinant proteins from vaccinia and expressed in C-PERL's proprietary larval expression system. The proposed vaccine will be targeted for the millions of people who cannot take the live virus vaccines for smallpox. The C-PERL system is a proprietary, automated baculovirus mediated system capable of producing recombinant proteins from the gram to the kilogram level. Some of the world's leading experts in both poxviruses and subunit vaccines will assist C-PERL in performing the work. The proposed vaccine has been tested and proved effective in a relevant, early phase animal model. C-PERL has an exclusive license for using the proteins in a subunit vaccine, and has demonstrated that its proprietary system can produce large quantities of high quality, functional recombinant proteins and in a scaleable, cGMP compliant process. The application is separated into thee milestones: (1) Development of a cGMP compliant process for the production of the subunit vaccine; (2) Completion of a mouse vaccinia challenge model and a monkey pox monkey model using protein produced in the C-PERL larval system; (3) Approval of an IND for testing of the subunit vaccine in a Phase l/ll human trial. Success in these three milestones will allow rapid progress towards Phase l/ll human trials and toward eventual use of the vaccine in the general population.

描述（由申请人提供）：Chesapeake PERL （C-PERL）是一家重组蛋白制造公司，提议开发一种基于牛痘重组蛋白的天花疫苗，并在C-PERL专有的幼虫表达系统中表达。拟议中的疫苗将针对数百万无法接种天花活病毒疫苗的人。C-PERL系统是一种专有的、自动化的杆状病毒介导系统，能够生产从克到公斤级的重组蛋白。世界上一些痘病毒和亚单位疫苗方面的顶尖专家将协助C-PERL开展这项工作。拟议的疫苗已在相关的早期动物模型中进行了测试并证明有效。C-PERL拥有在亚单位疫苗中使用这些蛋白质的独家许可，并已证明其专有系统可以生产大量高质量、功能性重组蛋白质，并且符合可扩展的cGMP标准。该申请分为三个里程碑：(1)开发符合cGMP的亚单位疫苗生产工艺；(2)利用C-PERL幼虫系统产生的蛋白构建小鼠痘苗攻毒模型和猴痘猴模型；(3)批准亚单位疫苗在i / ii期人体试验中的IND测试。这三个里程碑的成功将使该疫苗在i /ll期人体试验和最终在普通人群中使用方面取得快速进展。