Improved Anthrax Vaccine Stability & use of Adjuvants

提高炭疽疫苗的稳定性

• 批准号: 7009878
• 负责人: ALLAN WATKINSON
• 金额: $ 267.09万
• 依托单位: AVECIA BIOLOGICS, LTD
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-01 至 2008-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7009878
• 关键词: SDS polyacrylamide gel electrophoresis; anthrax vaccines; biotechnology; bioterrorism /chemical warfare; blood tests; chemical stability; cooperative study; crystallization; drug administration routes; drug quality /standard; enzyme linked immunosorbent assay; immunomodulators; laboratory mouse; lyophilization; nonhuman therapy evaluation; scanning electron microscopy; vaccine development; vaccine evaluation; western blottings

DESCRIPTION (provided by applicant): 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's 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 lyophilization, micro-encapsulation, micro-particle crystallization 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 optimization will be carried out using all technologies to produce formulations useable for accelerated stability trials in stage 2 and extensive previously developed Drug substance and Drug Product characterization 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 an emergency yielding greater protection to the public.

描述（由申请人提供）：本申请描述了一个四阶段的计划，以开发一种稳定性显著提高的炭疽rPA疫苗。该项目的产出将是一种候选疫苗，一旦成功获得许可，就不需要冷藏储存或供应链，为政府提供维护和部署成本较低的库存。这种疫苗在抵御极端温度方面的能力将更加强大，从而简化了在野外的使用。该计划还检查了不含水凝胶的配方，可能会产生更安全的产品。该项目分四个阶段研究冻干、微胶囊化、微颗粒结晶和玻璃化，目的是在不影响动物激射试验效力和使用替代标记物的免疫反应的情况下，只研究那些在稳定性方面有显著改善的技术。在第一阶段，将使用所有技术进行初步工艺开发和优化，以生产可用于第二阶段加速稳定性试验的配方，并将使用广泛的先前开发的原料药和药品特性测试和分析来检查这些技术对疫苗的影响。在第三阶段，将开发一种技术流程，以GMP中试工厂生产，生产将在第四阶段用于毒性的材料。然后，这些数据将用于设计、成本和计划非临床和临床项目，以获得许可。该计划的目标是开发一种比现有产品稳定性更好的炭疽疫苗。该计划的成功完成将产生一种候选炭疽疫苗，一旦获得许可，将减少维持国家储备的成本。此外，提高使用的稳定性和稳健性将大大简化在紧急情况下部署疫苗的后勤工作，从而更好地保护公众。