Live, oral, heat Stable S. typhi TY21a vaccine

口服热稳定伤寒沙门氏菌 TY21a 活疫苗

• 批准号: 7117613
• 负责人: Eric John Patzer
• 金额: $ 50.17万
• 依托单位: ARIDIS PHARMACEUTICALS, LLC
• 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 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7117613
• 关键词: Salmonella typhimurium; Salmonella vaccines; active immunization; bioterrorism /chemical warfare; chemical stability; communicable disease control; dosage forms; drug delivery systems; laboratory mouse; live vaccine; nonhuman therapy evaluation; oral administration; temperature; thermostability; typhoids; vaccine development; vaccine evaluation

DESCRIPTION (provided by applicant): Vaccines represent a proven and effective approach for assuring widespread protection of large populations and can be used to reduce the number of susceptible individuals prior to or immediately following a bioterrorism attack. This project addresses two significant problems that are raised by current bioterrorism threats: 1) the need for an easy method of mass vaccination and 2) the general lack of enteric disease vaccines, several of which are NIAID "category B" agents (e.g. Salmonella). In this context we propose to use Aridis' vaccine stabilization and delivery technologies to develop a room temperature stable, live, oral Salmonella typhi Ty21a vaccine in a delivery system, that requires no reconstitution or preparation time, e.g., quick dissolving thin films or tablets applied directly to the tongue. If we demonstrate that this system is compatible with delivery of Salmonella typhi and protects against typhoid fever, then this will be a significant step forward in developing stabilization and delivery systems for the other category A and B priority bacterial pathogens (approximately 40% of the total pathogens). The rationale underlying this approach is to exploit the extensive safety record of the existing live, oral Salmonella enterica serovar Typhi strain Ty21 a vaccine. Initially, we will use formulation selection and freeze dry foaming to produce solid foam preparations of Ty21a that do not require refrigeration. Next, we will develop a process to produce powders from the solid foam that do not require refrigeration and are suitable for further processing for oral delivery. Lastly, we will develop an alternative procedure, spray drying, to directly produce powders that do not require refrigeration and are suitable for further processing for oral delivery. Future goals, which will be part of a phase 2 SBIR application, will be to develop temperature responsive labels that ensure product quality at the single dose level and an easy to administer oral delivery system that does not require needles/syringes, reconstitution or skilled healthcare professionals for administration.

描述（由申请人提供）： 疫苗是确保对大量人群进行广泛保护的一种行之有效的方法，可用于在生物恐怖主义袭击之前或之后减少易感个体的数量。该项目解决了当前生物恐怖主义威胁引起的两个重大问题：1）需要一种简单的大规模疫苗接种方法；2）普遍缺乏肠道疾病疫苗，其中一些是 NIAID“B 类”疫苗（例如沙门氏菌） 。在这种情况下，我们建议使用 Aridis 的疫苗稳定和递送技术，在递送系统中开发室温稳定、活的、口服伤寒沙门氏菌 Ty21a 疫苗，无需重构或准备时间，例如应用快速溶解的薄膜或片剂直接到舌头。如果我们证明该系统与伤寒沙门氏菌的递送兼容并能预防伤寒，那么这将是在开发针对其他 A 类和 B 类优先细菌病原体（约占总数的 40%）的稳定和递送系统方面迈出的重要一步。病原体）。这种方法的基本原理是利用现有活口服肠沙门氏菌血清型伤寒菌株 Ty21 a 疫苗的广泛安全记录。最初，我们将采用配方选择和冷冻干燥发泡的方法来生产不需要冷藏的Ty21a固体泡沫制剂。接下来，我们将开发一种从固体泡沫生产粉末的工艺，该粉末不需要冷藏，并且适合进一步加工用于口服给药。最后，我们将开发一种替代程序，喷雾干燥，直​​接生产不需要冷藏且适合进一步加工用于口服给药的粉末。未来的目标是开发温度响应标签，确保单剂量水平的产品质量，并开发一种易于管理的口服给药系统，不需要针头/注射器、重构或熟练的医疗保健，这将是第 2 期 SBIR 应用的一部分。行政专业人员。

项目成果

Room temperature stabilization of oral, live attenuated Salmonella enterica serovar Typhi-vectored vaccines.

口服减毒活沙门氏菌血清型伤寒疫苗的室温稳定性。

• 发表时间: 2011-03-24
• 影响因子: 5.5
• 作者: Ohtake, Satoshi;Martin, Russell;Saxena, Atul;Pham, Binh;Chiueh, Gary;Osorio, Manuel;Kopecko, Dennis;Xu, Deqi;Lechuga;Truong
• 通讯作者: Truong