IMMUNE RESPONSES IN ACUTE HEPATITIS C INFECTION

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。 该项目的目标是确定最近(9个月内)感染丙型肝炎病毒的受试者，并研究免疫系统处于最早反应阶段。采集期为3年(每年10个研究对象，当地)。共有100名受试者将从全国各地的网站上招募。 检测结果证实最近感染的筛查受试者将收到有关丙型肝炎病毒感染的文献和治疗方案，并将被转介到研究中，如果他们愿意的话，将得到同意。受试者选择治疗或拒绝治疗不会影响他们对研究的参与 研究对象将在基线、2个月、4个月、6个月和12个月时采集一品脱血液，为期一年。在为期9个月的访问中，将抽取6管血液，2管用于病毒载量的血浆分析，2管用于T细胞分析，1管用于肝功能分析，1管用于监测白细胞变化。每次就诊时，用ALT、AST和总胆红素监测肝功能。将进行完整的血细胞计数，以提供有关病毒发展期间白细胞计数和白细胞变化的信息。与生活方式和风险因素有关的问卷将在基线、6个月和12个月自行完成。有关丙型肝炎病毒治疗的问题将在6个月和12个月时被问及。从问卷中收集的答案将使我们能够将风险因素(例如反复接触)与感染结果进行匹配。此外，在我们检查个体免疫反应时，了解抗病毒治疗的选择也是重要的。 为了成功地跟踪整个一年的主题，将在诊所就诊之间进行电话访问。这些电话将确认联系信息，并捕获与研究相关的任何不良事件。 丙型肝炎病毒的急性期在识别人类受试者方面造成了特别的问题，因为感染的症状很少提醒护理人员病毒的存在。丙型肝炎病毒感染的症状一般不会出现，直到感染达到慢性阶段，如果他们出现的话。由于丙型肝炎病毒急性期的研究对象很少在临床环境中被确定，这项研究提供了一个独特的机会来识别和跟踪一个到目前为止很少被检查的人群的免疫反应。将自发清除感染或接受抗病毒治疗的个人的免疫反应与免疫反应不足以解决感染的个人(成为慢性感染者)进行比较。这项研究的结果将回答对开发疫苗和更有效地治疗丙型肝炎至关重要的重要问题。

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 goal of the project is to identify subjects who have recently (within a 9 month period) become infected with hepatitis C virus and to study the immune system is in its earliest stages of response. The duration of the collection period will be 3 years (10 study subjects per year, locally.) A total of 100 subjects will be recruited from sites around the country. Screened subjects with test results confirming recent infection will receive literature about HCV infection, and treatment options, and will be referred to the study to be consented if they so choose. The subject's option to choose treatment or refuse treatment will not effect their participation in the study Study subjects will be followed over a one year period with a pint of blood collected at baseline, 2, 4, 6, and 12 months. There will be a 9 month visit where six tubes of blood will be drawn, two for plasma analysis for viral load, two for T-cell analysis, one for liver function analysis and one to monitor white blood cell changes. At each visit liver function will be monitored with ALT, AST, and total Bilirubin. A complete blood count will be performed to provide information about changes in white blood count and leukocytes over the period of development of the virus. Questionnaires relating to lifestyle and risk factors will be self administered at baseline, 6 and 12 months. Questions about treatment for HCV will be asked at 6 and 12 months. The answers collected from the questionnaires will allow us to match risk factors, for instance, repeated exposures, to outcome of infection. Also, it will be important to know about antiviral treatment choices as we examine the individual immune responses. In an effort to successfully follow the subject for the entire year, telephone visits will be conducted in between clinic visits. These calls will confirm contact information and capture any adverse event that is related to the study. The acute phase of HCV poses particular problems in identifying human subjects, because symptoms of the infection rarely alert care providers to the presence of the virus. Symptoms of the HCV infection generally do not appear until the infection has reached the chronic stage, if they appear at all. Since subjects for the study of the acute phase of HCV are rarely identified in a clinic setting, this study presents a unique opportunity to identify and follow immune responses in a population that has until now rarely been examined. The immune response of individuals who spontaneously clear the infection or who receive antiviral treatment will be compared to the individuals whose immune responses are inadequate to resolve the infection (those who become chronically infected.) The results of the research conducted in this study will answer the important questions vital to the development of a vaccine and more effective treatment of the hepatitis C infection.