VACCINE FOR CLOSTRIDIUM DIFFICILE DISEASE

拟议研究的目标是开发一种疫苗和/或抗体。 防治难辨梭状芽孢杆菌的有效制剂 相关性腹泻(CDAD)。艰难梭菌肠外免疫接种 A)阿尔茨海默病动物模型中的类毒素已显示出保护作用 挑战。此外，非肠道注射的毒素中和 抗体可以保护动物免受CDAD的侵袭。抗原生产方法有 已被开发并将用于生产临床疫苗 测试。血浆捐献者将用疫苗进行免疫，以生产 治疗和预防CDAD的高免球蛋白制剂 在临床试验中。老年人艰难梭菌医院感染情况分析 通常会导致严重的发病率和住院时间的增加 尽管有有效的治疗方法，但仍会留下来。由于以下原因导致的医疗成本 延长住院时间、诊断检测和艰难梭菌的特异性 治疗是实质性的。免疫治疗对感染C. 艰难或处于危险中将提供一种具有成本效益的预防策略 控制艰难梭菌感染。被动免疫可以迅速保护 处于危险中的个人，将为活性疫苗的开发铺平道路 通过定义人类体内抗毒素抗体的保护水平。目标是 使用免疫球蛋白可以实现快速和长期的保护 策略和疫苗一起使用。 建议的商业应用： 艰难梭菌感染是医院内的主要疾病之一。 在美国，作为抗生素相关疾病的主要病原体 腹泻，这种细菌会造成相当大的不适和 增加了医疗保健成本。艰难梭菌病是疫苗可以预防的。 免疫疗法提供了一种成本效益高的策略，它将导致 大大节省了医疗费用，降低了发病率。

The goal of the proposed research is to develop a vaccine and/or antibody preparation useful for prevention and treatment of Clostridium difficile associated diarrhea (CDAD). Parenteral vaccination with C. difficile toxoid in animal models of a)AD has demonstrated protection from challenge. Furthermore, parenterally administered toxin neutralizing antibodies can protect animals from CDAD. Antigen production methods have been developed and will be used to manufacture vaccine for clinical testing. Plasma donors will be immunized with the vaccine to produce hyperimmune globulin preparations for use in treating and preventing CDAD in clinical trials. Nosocomial infection of the elderly with C. difficile often results in significant morbidity and increased length of hospital stays in spite of effective therapies. The health care costs due to prolonged hospitalization, diagnostic testing and specific C. difficile therapy are substantial. Immunotherapy of patients infected with C. difficile or at risk would offer a cost-effective preventative strategy to control C. difficile infection. Passive immunization can rapidly protect individuals at risk and will pave the way for active vaccine development by defining protective levels of antitoxin antibodies in humans. The goal of rapid and long term protection could be achieved using immune globulin strategies along with the vaccine. PROPOSED COMMERCIAL APPLICATION: Clostridium difficile infection is one of the leading nosocomial diseases in the U.S. As the primary etiological agent of antibiotic-associated diarrhea, this organism is responsible for considerable discomfort and increased health care costs. C. difficile disease is vaccine preventable. Immunotherapy provides a cost-effective strategy that would result in substantial savings in medical costs and reduced morbidity.