Clinical Core

位于华盛顿大学病毒学研究诊所(UW-VRC)的临床核心一直是 自近40年前成立以来，一直致力于生殖器单纯疱疹病毒(HSV)的研究。特定的 临床核心的目标是：1)招募、招募和留住来自Defined的受试者 项目2和项目3的人群，包括患有轻度和重度生殖器HSV-2表型的参与者，以及 项目4中感染了原始生殖器HSV-1的参与者；2)确保收集的数据的完整性 项目2、3和4，坚持研究程序，促进人类学科的最高标准 研究，包括坚持良好的临床实践；以及3)获得所需的临床样本 病毒学和免疫学调查，包括项目3和4，生殖器粘膜部位的拭子 项目2和3的活组织检查，项目2，3和4的血液和详细的临床病史。此外， 临床核心将负责培训肯尼亚锡卡的工作人员，为项目1。 临床核心组织率先进行了密集的生殖器样本收集，以确定HSV的自然历史 脱落和寄主-病原菌的相互作用。我们的历史记录表明，我们可以留住这些项目的参与者 密集的方案，包括每天自我收集的生殖器拭子。我们已经招收了近1000名学生 这些研究的参与者。我们已经开发了收集生殖器活组织检查的专业知识，我们可以 安全地收集参与者的连续生殖器活检，以进行详细的免疫学和发病机制研究 在科学项目中提出。 临床核心与实验室核心和统计核心密切合作，评估新的HSV 测试方法，如HSV聚合酶链式反应，并回答HSV研究中的新问题，我们将继续 在此POI中执行此操作。临床核心还将确保所有临床研究都是在最高 道德标准和对良好临床实践(GCP)的坚持。

The Clinical Core, located at the University of Washington Virology Research Clinic (UW-VRC), has been devoted to genital herpes simplex virus (HSV) research since it was founded nearly 40 years ago. Specific Aims of the Clinical Core are 1) To recruit, enroll, and retain participants into research protocols from defined populations, including participants with mild and severe genital HSV-2 phenotypes for Projects 2 & 3, and participants with primary genital HSV-1 infection for Project 4; 2) To ensure integrity of data collected for Projects 2, 3, and 4 by adhering to study procedures and promoting the highest standards of human subjects research, including adherence to Good Clinical Practice; and 3) To obtain clinical specimens required for virologic and immunologic investigations including swabs from mucosal sites for Projects 3 & 4, genital biopsies for Projects 2 & 3, and blood and detailed clinical histories for Projects 2, 3, & 4. In addition, the Clinical Core will be responsible for training staff in Thika, Kenya, for Project 1. The Clinical Core has pioneered intensive genital specimen collection to define the natural history of HSV shedding and host-pathogen interactions. Our track record shows that we can retain participants in these intensive protocols which involve daily self-collected genital swabs. We have enrolled nearly 1000 participants in such studies. We have developed expertise in collection of genital biopsies, and we can safely collect serial genital biopsies from participants for detailed immunological and pathogenesis studies proposed in Scientific Projects. The Clinical Core collaborates closely with the Laboratory Core and the Statistical Core to evaluate new HSV testing methods, such as HSV PCR, and to answer novel questions in HSV research and we will continue to do so in this POI. The Clinical Core will also ensure that all clinical research is conducted with the highest ethical standards and with adherence to Good Clinical Practice (GCP).