Improved Anthrax Vaccine Stability & use of Adjuvants

提高炭疽疫苗的稳定性

• 批准号: 7667589
• 负责人: ALLAN WATKINSON
• 金额: $ 123.51万
• 依托单位: PHARMATHENE UK LIMITED
• 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 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7667589
• 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程序，以开发具有显着改善稳定性的炭疽RPA疫苗。该计划的产出将是候选疫苗的候选者，即成功许可后不需要冷藏储存或供应链，从而为政府提供了维护和部署成本较低的库存。就其承受极端温度简化现场使用的温度的能力而言，该疫苗将更加强大。该计划还研究了不包含阿赫米尔德盖的制剂可能会产生更安全的产品。 该计划研究冻干，微囊化，微粒子结晶和玻璃化四个阶段，旨在进步，仅在动物挑战测试和使用替代标记物的动物挑战测试和免疫学反应中损害稳定性的可测量提高而没有损害效力。在第1阶段，将使用所有技术进行初始过程的开发和优化，以生产可在第2阶段使用的加速稳定性试验的制剂，并使用广泛的先前开发的药物和药物产品表征测试和测定方法来检查技术对疫苗的影响。在第3阶段，将开发一个技术过程，以制造GMP Pilot工厂生产，以生产将在第4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计划以获得许可。 与当前可用产品相比，该计划的目标是针对炭疽疫苗的开发，其稳定性提高。该计划的成功完成将产生炭疽疫苗的候选者，当获得许可时，将降低维持国家库存的成本。此外，使用的稳定性和鲁棒性的提高将极大地简化物流，以在紧急情况下部署疫苗，从而为公众提供更大的保护。