Preliminary Effectiveness Analysis of Universal Rotavirus Immunization, Nicaragua

描述（由申请人提供）：候选人：西尔维亚贝克尔，医学博士，公共卫生硕士是一个在家庭医学系在北卡罗来纳州大学在查佩尔山（北卡罗来纳州）的NRSA初级保健研究员。职业发展计划：候选人将进行指导研究，并加强全球健康研究的重要知识。候选人将成为发展中国家疫苗有效性的领导者。近期目标：获得传染病流行病学和疫苗有效性方面的专业知识;评估轮状病毒疫苗在发展中国家的有效性。长期目标：为发展中国家的决策者提供疫苗有效性的证据。具体目的：1）确定轮状病毒疫苗在初级保健环境中的有效性。2)描述UIRI实施后病毒的流行基因型。3)确定在一个社区中实施统一免疫接种对儿童腹泻发病率的影响。研究方法：在目标1中，我们将采用病例对照设计，以确定疫苗在减少尼加拉瓜莱昂8个初级保健中心轮状病毒腹泻儿童初级保健就诊方面的有效性。在目标2中，我们将描述目标1中收集的所有轮状病毒阳性粪便样本的基因型，并探讨是否可能发生类型替换。在目标3中，我们将使用尼加拉瓜大学莱昂分校（UNAN）现有监测系统提供的基于人群的样本测量社区儿童的腹泻发病率，并与轮状病毒普遍免疫接种前的发病率进行比较。环境：我们将与莱昂的八个初级保健中心合作，这些中心与研究团队成员有着悠久的合作历史。目标1的实验室研究将在UNAN的一个实验室进行，目标2的实验室研究将在CDC进行。目标3将利用现有的监测系统，该系统因其研究质量而享有国际声誉。数据库管理在该监督系统内。导师制：流行病学家和传染病专家大卫J.韦伯，医学博士，公共卫生硕士将提供初级导师制。UNAN的主要导师将由Felix Espinoza，MD，PhD（目标1和2）和Rodolfo Peria，MD，PhD（目标3）提供。轮状病毒流行病学和疫苗有效性方面的领导人Umesh Parashar和Manish Patel博士、医学地理学家Micheal Emch博士、生物统计学家Michael Hudgens博士、疫苗流行病学家Jennifer Smith博士和胃肠病学家道格拉斯摩根博士提供了额外的指导，他领导了UNC-UNAN研究合作。 公共卫生相关性：我们在尼加拉瓜莱昂有独特的机会来确定UIRI对初级保健和社区水平的影响。在拟议的研究结束时，我们将向目前正在考虑将轮状病毒疫苗加入其疫苗库的发展中国家提供所需的信息。

DESCRIPTION (provided by applicant): Candidate: Sylvia Becker, MD, MPH is an NRSA-Primary Care Research Fellow in the Department of Family Medicine at the University of North Carolina at Chapel Hill (UNC). Career Development Plan: the candidate Will conduct mentored research and strengthen vital knowledge in global health research. The candidate will be positioned to become leader in vaccine effectiveness in the developing world. Immediate Objective: to acquire expertise in infectious disease epidemiology and vaccine effectiveness; to assess the effectiveness ofthe rotavirus vaccine in a developing world setting. Long-term Objective: to provide evidence on vaccine effectiveness for developing world decision makers. Specific Aims: 1) Determine the effectiveness ofthe rotavirus vaccine in the primary care setting. 2) Characterize the circulating genotypes of the virus following UIRI implementation. 3) Determine the effect of UIRI on the childhood diarrhea incidence rate in a community. Research Methods: In Aim 1, we will a case control design to determine the vaccine's effectiveness in reducing primary care visits among children for rotavirus diarrhea at eight primary care centers in Leon, Nicaragua. In Aim 2, we will characterize the genotypes among all rotavirus-positive stool samples collected in Aim 1 and explore whether type replacement may be occurring. In Aim 3, we will measure the diarrhea incidence rate among children in the community using a population-based sample provided by an existing Surveillance System based at University of Nicaragua, Leon (UNAN) and compare to the incidence prior to universal rotavirus immunization. Environment: we will work with eight primary care centers in Leon that have a long history of collaboration with members of the research team. Laboratory studies for Aim 1 will be carried out in a laboratory at UNAN while those for Aim 2 will be carried out at the CDC. Aim 3 will make use of an existing Surveillance System that has an international reputation for the quality of its research. Database management is within this Surveillance System. Mentorship: primary mentorship at the UNC will be provided by epidemiologist and infectious disease specialist, David J. Weber, MD, MPH. Primary mentorship at UNAN will be provided by Felix Espinoza, MD, PhD (Aims 1 and 2) and Rodolfo Peria, MD, PhD (Aim 3). Additional mentorship is provided by leaders in rotavirus epidemiology and vaccine effectiveness, Drs. Umesh Parashar and Manish Patel, by medical geographer, Micheal Emch, PhD, by biostatistician, Michael Hudgens, PhD, by vaccine epidemiologist Jennifer Smith, PhD, MPH, and by gastroenterologist, Douglas Morgan, MD, MPH, who has led the UNC-UNAN research collaboration. PUBLIC HEALTH RELEVANCE: We have the unique opportunity in Leon, Nicaragua to determine the effect of UIRI on the primary care and community levels. At the end of the proposed study, we would provide needed information to others in the developing world who are currently considering adding rotavirus vaccines to their vaccine armamentarium.