Improved Anthrax Vaccine Stability & use of Adjuvants

项目摘要 本申请描述了开发炭疽RPA疫苗的四个阶段计划，该疫苗具有显著的 提高了稳定性。该程序的输出将是候选疫苗，当成功 许可不需要冷藏存储或供应链，为政府提供 维护和部署成本更低。就其抵抗力而言，疫苗将更加强健 极高的温度，简化了现场使用。该程序还会检查那些不能 含有氢凝胶，可能会产生更安全的产品。 该计划研究冷冻干燥、微胶囊化、微粒结晶和玻璃化。 四个阶段，旨在只进步那些在稳定性方面表现出可衡量的改进的技术 在不影响使用替代物的动物挑战试验和免疫反应的效力的情况下 记号笔。在第一阶段，将使用所有技术进行初始流程开发和优化，以 生产可用于第二阶段加速稳定性试验的配方，以及先前开发的大量配方 将使用药物物质和药品表征测试和分析来检查 疫苗上的技术。在第三阶段，将开发一种技术流程，用于GMP中试生产 以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 计划一个非临床和临床项目，以获得许可。 相关性 该计划的目标是开发一种稳定性比现有疫苗更好的炭疽疫苗。 产品。该计划的成功完成将产生一种炭疽疫苗候选疫苗，当 获得许可将减少维护国家库存的成本。此外，提高了稳定性和 使用的健壮性将极大地简化在紧急情况下部署疫苗的后勤工作 对公众的更大保护。

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.