ENTERIC PATHOGENS - MUCOSAL RESEARCH UNIT

这份合同的目标是了解人类粘膜免疫 感染或接种肠道细菌和疫苗所产生的反应 病毒。这些信息是需要的，以便制定有效的 针对肠道病原体的疫苗接种策略。承包商将 利用对成人志愿者的研究来实现以下目标 那份合同。个人将面临基因弱化的挑战 (减毒)或野生型大肠杆菌、沙门氏菌、志贺氏菌 霍乱弧菌、弯曲杆菌、幽门螺杆菌、 轮状病毒、其他肠道病毒或其他适当的生物体。他们的 对这种挑战的免疫反应将广泛地表现在 以确定免疫反应的那些相关方面 保护它们免受野生型生物的挑战。一旦被确认， 将通过迭代方法作出进一步努力，以最大限度地 免疫反应的保护性方面，通过使用不同的 佐剂、给药系统、给药时间表或其他方法。 承包商将从以下地点招募成年志愿者 巴尔的摩/华盛顿大都市社区，对他们进行适当的筛选 免疫状态，指导他们了解研究的性质及其 目的：在医院隔离病房或住院期间进行研究 适当时在门诊就诊，并提供必要的跟进和 为所有志愿者提供治疗。 另一个目的是承包商将有效地和 经常与第二个承包商进行同等的研究 呼吸道病原体(贝勒医学院，N01-AI-65298)。它是 预计这两个集团将达到协同效应 进一步加深我们对人类粘膜免疫的了解 回应。这样的结果可能会有利于对其他疾病的研究 而不是与消化系统或呼吸系统相关的疾病。它是 预计这些研究将导致更有效的疫苗 应对大量传染病的战略。

The objective of this contract is to understand the human mucosal immune response generated by infection or vaccination with enteric bacteria and viruses. This information is needed in order to develop effective vaccination strategies against enteric pathogens. The contractor will employ studies of human adult volunteers to accomplish the objectives of the contract. Individuals will be challenged with genetically weakened (attenuated) or wild-type Escherichia coli, Salmonella species, Shigella species, Vibrio cholerae, Campylobacter species, Helicobacter pylori, rotavirus, other enteric viruses, or other appropriate organisms. Their immune response to such challenge will be extensively characterized in order to identify those aspects of the immune response that correlate with protection from challenge by wild-type organisms. Once identified, further efforts will be made through iterative methodology to maximize that protective aspect of the immune response through the use of various adjuvants, delivery systems, dosing schedules or other methods. The contractor will recruit adult volunteers from the Baltimore/Washington metropolitan community, screen them for appropriate immune status, instruct them about the nature of the study and its objectives, perform the studies on an isolation ward in the hospital or in out-patients when appropriate, and provide the necessary follow-up and treatment for all volunteers. It is further intended that the contractor will interact effectively and frequently with a second contractor working on equivalent studies of respiratory pathogens (Baylor College of Medicine, N01-AI-65298). It is anticipated that synergistic effects will be achieved by these two groups in the furthering of our understanding of the human mucosal immune response. Such a result will likely benefit studies of diseases other than those associated with the digestive or respiratory systems. It is anticipated that these studies will lead to more effective vaccine strategies against a large number of infectious diseases.