CAMPYLOBACTOR JEJUNI CHALLENGE MODEL DEVELOPMENT: DOSE-RANGING STUDY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的原因是为了开发一种空肠弯曲菌感染模型，空肠弯曲菌是一种导致食物和水传播疾病(主要是腹泻)的细菌。开发该模型的主要目标是在尽可能安全的情况下，找到一种剂量的弯曲杆菌，它能在4名志愿者中约3人引发腹泻。这些信息将有助于开发针对弯曲杆菌感染的疫苗。 志愿者将在注册前60天内接受资格筛选。筛查将包括在任何研究程序之前获得签署的知情同意。接下来是病史、目前的药物和安全实验室的血液样本(WBC、Hct、HGB、血小板计数；化学板；HIV、人类白细胞抗原B27、乙肝病毒和丙型肝炎病毒的筛查；女性的尿孕测试)。 符合条件的志愿者将在第一天的前一天晚上登记并进入GCRC。在挑战摄入第0天后，志愿者将进行抽血，包括安全实验室和免疫反应，收集粪便样本，体重和测试，体征和症状复查，以及临床评估。在所有住院日，即第0天至第9天，以及预定的研究日，即第14天和第28天，都将征集不良反应和相关药物的记录。所有受试者都将接受抗生素治疗，并在12小时内连续两次粪便培养呈阴性，才有资格出院。第14天和第28天的两次门诊随访，抽血包括安全实验室和免疫反应，并将有6个月的电话评估，以检查志愿者的状态。 计划在每个队列完成住院阶段后举行第一次dsmb会议。对剂量水平的安全性进行评估，并确定下一个队列是否应该继续下一个更高的剂量。这项早期评估的主要目标是审查安全数据。如认为有必要，也可临时召开dsmb会议。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The reason for this research is to develop a model of infection with Campylobacter jejuni, a bacterium that causes food and water-borne disease (mainly diarrhea). The main goal in developing the model is to find a dose of the Campylobacter bacteria that causes diarrhea in about 3 out of 4 volunteers while being done as safely as possible. This information will assist the development of a vaccine against Campylobacter infections. Volunteers will be screened for eligibility within 60 days prior to enrollment. Screening will include obtaining signed informed consent prior to any study procedure. This will be followed by medical history, current medications, and blood samples for safety labs (WBC, HCT, HGB, platelet count; chemistry panel; screening for HIV, HLA-B27, HBV, and HCV; urine pregnancy testing for females). Eligible volunteers will be enrolled and admitted to the GCRC the night before, Day -1. Following challenge ingestion Day 0, the volunteers will have blood drawn to include safety labs and immunologic response, stool specimen collected, weight and tested, review of signs and symptoms, and clinical assessment. solicitation of AEs and documentation of concomitant medications will occur on all inpatient days, Day 0 to Day 9 and on scheduled study days, Day 14 and Day 28. All subjects will receive antibiotics and have two consecutive negative stool cultures within 12 hours to be eligible for discharge. Two outpatient follow up visits on Day 14 and Day 28 with blood drawn to include safety labs and immunologic response and There will be a 6 month phone assessment to check status of volunteers. The first DSMB meeting is planned, to occur after each cohort has completed the inpatient phase. An assessment regarding the safety of the dose level and determine if the next cohort should continue at the next higher dose. The main goal of this early assessment is to review safety data. DSMB meetings may also be called on an ad hoc basis when deemed necessary.