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Improved Anthrax Vaccine Stability & use of Adjuvants

提高炭疽疫苗的稳定性

基本信息

批准号：
7438610
负责人：
ALLAN WATKINSON
金额：
$ 299.98万
依托单位：
AVECIA BIOLOGICS, LTD
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-08-01 至 2008-09-18
项目状态：
已结题

项目摘要

Project Summary This application describes a four stage program to develop an Anthrax rPA vaccine with a significantly improved stability. An output from this program would be a vaccine candidate that when successfully licensed does not require refrigerated storage or supply chain, providing the government with a stockpile that is less costly to maintain and deploy. The vaccine would be more robust in terms of it ability to withstand temperature extremes simplifying use in the field. The program also examines formulations that do not contain alhyrdrogel potentially yielding a safer product. The program studies lyophilisation, micro-encapsulation, micro-particle crystallisation and glassification in four stages designed to progress only those technologies showing a measurable improvement in stability without compromising potency in an animal challenge test and immunological response using surrogate markers. In stage 1 initial process development and optimisation will be carried out using all technologies to produce formulations usuable for accelerated stability trials in stage 2 and extensive previously developed Drug substance and Drug Product characterisation tests and assays will be used to examine the effect of the technologies on the vaccine. In Stage 3 will develop one technology process to GMP pilot plant manufacture to produce material that will be used in stage 4 for toxicity. This data will then be used to design, cost and plan a non-clinical and clinical program to achieve license. Relevance This program targets the development of an anthrax vaccine with improved stability over currently available products. The successful completion of the program would yield an anthrax vaccine candidate that when licensed would reduce the costs of maintaining a National Stockpile. In addition, improved stability and robustness in use would greatly simplify the logistics for deploying the vaccine in a emergency yielding greater protection to the public.

项目概要该申请描述了开发炭疽 rPA 疫苗的四阶段计划，该疫苗具有显着的效果提高稳定性。该计划的输出将是一种候选疫苗，一旦成功获得许可不需要冷藏或供应链，为政府提供了库存维护和部署成本较低。疫苗的抵抗力会更强极端温度简化了现场使用。该计划还检查了不含有水凝胶，可能会产生更安全的产品。该项目研究冷冻干燥、微胶囊化、微粒结晶和玻璃化四个阶段旨在仅推进那些稳定性显着提高的技术不影响动物激发试验和使用替代品的免疫反应的效力标记。在第一阶段，将使用所有技术进行初始工艺开发和优化生产可用于第二阶段加速稳定性试验和先前开发的广泛配方原料药和药品特性测试和测定将用于检查药物的效果疫苗方面的技术。第三阶段将开发一种 GMP 中试工厂制造技术流程生产用于第四阶段毒性检测的材料。然后，该数据将用于设计、成本和规划非临床和临床项目以获得许可。关联该计划的目标是开发一种比现有疫苗稳定性更高的炭疽疫苗产品。该计划的成功完成将产生一种候选炭疽疫苗，当获得许可将降低维护国家库存的成本。此外，还提高了稳定性和使用的稳健性将大大简化在紧急情况下部署疫苗的后勤工作对公众有更大的保护。