Clinical Core

位于华盛顿大学病毒学研究诊所（UW-VRC）的临床核心， 生殖器疱疹病毒（HSV）是一种常见的生殖器疱疹病毒。具体 临床核心的目的是1）招募、登记和保留参与者进入研究方案， 人群，包括项目2和3中具有轻度和重度生殖器HSV-2表型的参与者，以及 项目4的原发性生殖器HSV-1感染受试者; 2）为了确保收集的数据的完整性， 项目2、3和4通过坚持研究程序和促进人类受试者的最高标准 研究，包括遵守《药物临床试验质量管理规范》;以及3）获得所需的临床标本， 病毒学和免疫学研究，包括项目3和4的粘膜部位拭子，生殖器 项目2和3的活组织检查，以及项目2、3和4的血液和详细的临床病史。此外该 临床中心将负责在肯尼亚蒂卡培训项目1的工作人员。 临床中心开创了密集的生殖器标本收集，以确定HSV的自然史 脱落和宿主-病原体相互作用。我们的业绩记录表明，我们可以留住这些参与者， 包括每日自我采集生殖器拭子的强化方案。我们已经招收了近1000人 参与这些研究。我们在收集生殖器活检方面积累了专业知识，我们可以 从参与者中安全收集一系列生殖器活检，用于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，以评估新的HSV 检测方法，如HSV PCR，并回答HSV研究中的新问题，我们将继续 在这个POI中。临床核心还将确保所有临床研究都是以最高的标准进行的。 道德标准，并遵守良好的临床实践（GCP）。 相关性（参见说明）： 临床中心位于华盛顿大学病毒学研究诊所（UW-VRC）， 负责招募、登记和保留项目2、3中所述方案的参与者， 和4，以及在肯尼亚为项目1培训工作人员。我们将获得详细的病史，血液样本，生殖器 拭子和生殖器活检，我们将确保在我们的研究中遵循良好的临床实践。

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 neariy 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 Pracfice; and 3) To obtain clinical specimens required for virologic and immunologic invesfigafions 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 collecfion 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 neariy 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). RELEVANCE (See instructions): The Clinical Core is located atthe University of Washington Virology Research Clinic (UW-VRC) and will be responsible for recruitment, enrollment and retenfion of participants into protocols described in Projects 2, 3, and 4, and training of staff in Kenya for Project 1. We will obtain detailed histories, blood samples, genital swabs, and genital biopsies, and we will ensure that Good Clinical Practice is followed in our studies.