CAMPYLOBACTOR JEJUNI CHALLENGE MODEL DEVELOPMENT: DOSE-RANGING STUDY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项研究的原因是开发一种空肠弯曲菌感染模型，空肠弯曲菌是一种引起食物和水传播疾病（主要是腹泻）的细菌。开发该模型的主要目标是找到一种剂量的弯曲杆菌细菌，该细菌在4名志愿者中约有3名会引起腹泻，同时尽可能安全地进行。这些信息将有助于开发针对弯曲杆菌感染的疫苗。 将在入组前60天内筛选志愿者的合格性。筛选将包括在任何研究程序之前获得签署的知情同意书。随后将提供病史、当前药物和安全实验室的血液样本（WBC、HCT、HGB、血小板计数;化学检查; HIV、HLA-B27、HBV和HCV筛查;女性尿妊娠检测）。 合格志愿者将在第-1天前一晚入组并进入GCRC。第0天攻毒摄入后，将对志愿者进行抽血，包括安全性实验室检查和免疫学反应、粪便标本采集、体重和检测、体征和症状审查以及临床评估。将在所有住院日（第0天至第9天）和计划的研究日（第14天和第28天）收集AE和记录伴随用药。 所有受试者将接受抗生素治疗，并在12小时内连续两次粪便培养阴性，才有资格出院。在第14天和第28天进行两次门诊随访访视，抽血以包括安全性实验室检查和免疫学应答， 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期后召开首次DSMB会议。评估剂量水平的安全性，并确定下一个队列是否应继续使用下一个更高剂量。该早期评估的主要目标是审查安全性数据。必要时，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.