VACCINE FOR CLOSTRIDIUM DIFFICILE DISEASE

拟议研究的目标是开发疫苗和/或抗体 用于预防和治疗艰难梭菌的制剂 相关性腹泻（CDAD）。用C.艰难 a）AD的动物模型中的类毒素已经证明了对 挑战.此外，胃肠外给药的毒素中和 抗体可以保护动物免于CDAD。抗原生产方法具有 已开发并将用于生产临床用疫苗 试验.血浆捐献者将接种疫苗， 用于治疗和预防CDAD的超免疫球蛋白制剂 在临床试验阶段老年人医院内感染念珠菌。艰难 通常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。医疗保健费用由于 延长住院时间，诊断测试和特定的C。艰难 治疗是实质性的。C.感染者的免疫治疗 困难或有风险的疾病将提供一种具有成本效益的预防策略， 对照C.艰难感染被动免疫可以迅速保护 并将为主动疫苗的开发铺平道路 通过定义人体内抗毒素抗体的保护水平。目标 使用免疫球蛋白可以实现快速和长期的保护 策略沿着疫苗。 拟定商业应用： 艰难梭菌感染是主要的医院内疾病之一 在美国，作为糖尿病相关疾病的主要病原体， 腹泻，这种有机体是相当大的不适负责， 增加了医疗保健费用。C.艰难梭菌病是可以用疫苗预防的。 免疫疗法提供了一种具有成本效益的策略， 大量节省医疗费用和降低发病率。

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.