Enhanced Surveillance for New Vaccine Preventable Disease

描述（由申请人提供）：本合作协议的目的是通过加强住院和急诊科（ED）监测、应用流行病学研究和研究者发起的调查，支持提供新疫苗使用、新疫苗和即将推出的疫苗的影响以及其他免疫预防、新疫苗政策和正在考虑的政策的监测和数据收集的站点网络。这个新疫苗监测网络（NVSN）将处理“健康人2020”免疫和传染病的优先领域，特别是减少或消除疫苗可预防的疾病，并评估普遍推荐疫苗的疫苗接种覆盖率。NVSN项目的目的是利用基于人群的站点网络对急性胃肠炎进行主动监测，并提供一个框架来研究其他重要的疫苗相关问题。主要重点将是描述轮状病毒感染的负担和流行病学，导致15天至11岁之间的住院和急诊科就诊，使用急性胃肠炎的主动监测。将在2个环境（医院和急诊科）进行急性胃肠炎的主动监测，以确定每个环境中急性胃肠炎和轮状病毒的疾病负担，并检查一段时间内（许可前和许可后）的趋势。在急诊科住院或照顾的年龄小于11岁的有age症状的儿童将被筛选，如果他们符合资格标准并同意参加研究，将被邀请参加。将收集所有入组儿童的人口统计和临床数据。将收集粪便标本并检测轮状病毒。将对数据进行分析，以估计基于人群的轮状病毒住院率和急诊科就诊率，以表征轮状病毒引起的急性胃肠炎儿童的临床和流行病学因素。利用本研究获得的轮状病毒病例，对轮状病毒疫苗的有效性和轮状病毒疾病的成本进行应用流行病学评估，并利用该监测系统获得的特征明确的数据和标本，检查诺如病毒等其他病原体的负担。

DESCRIPTION (provided by application): The purpose of this cooperative agreement is to support a network of sites that provide surveillance and data collection on new vaccine use, the impact of the new vaccines and upcoming vaccines and other immunoprophylaxis, new vaccine policies and policies under consideration, through enhanced inpatient and emergency department (ED) surveillance, applied epidemiologic research, and investigator-initiated investigations. This New Vaccine Surveillance Network (NVSN) will address the Healthy People 2020 priority area for immunization and infectious diseases, specifically, the reduction or elimination of vaccine preventable diseases and evaluating vaccination coverage for universally recommended vaccines. The intent of the NVSN program is to utilize a network of population-based sites to conduct active surveillance for acute gastroenteritis in addition to providing a framework in which to study other important vaccine related questions. The major focus will be to describe the burden and epidemiology of rotavirus infection resulting in hospitalization and ED visits between 15 days and 11 years of age using active surveillance for acute gastroenteritis. Active surveillance for acute gastroenteritis will be conducted in 2 settings (hospital and ED) to determine the disease burden of acute gastroenteritis and rotavirus in each of these settings and to examine trends over time (pre- and post-licensure). Children <11 years of age hospitalized or cared for in the ED with symptoms of AGE will be screened, invited to participate if they meet eligibility criteria and consented for the study. Demographic and clinical data will be collected on all enrolled children. A stool specimen will be collected and tested for rotavirus. Data will be analyzed to estimate population-based rotavirus hospitalization and ED visit rates, to characterize the clinical and epidemiologic factors of children with acute gastroenteritis due to rotavirus, to utilize rotavirus cases obtained through this study to conduct applied epidemiologic evaluations of the effectiveness of rotavirus vaccines and costs of rotavirus disease and to examine the burden of other pathogens such as norovirus using the well characterized data and specimens obtained through this surveillance system. PUBLIC HEALTH RELEVANCE: The New Vaccine Surveillance Network will address the Healthy People 2020 priority area for immunization and infectious diseases, specifically, the reduction or elimination of vaccine preventable diseases and evaluating vaccination coverage for universally recommended vaccines. Prior to the introduction of rotavirus vaccines in the US, rotavirus was responsible for an estimated 2.7 million episodes of acute gastroenteritis, 410,000 physician visits, 205-272,000 ED visits, 55-70,000 hospitalizations and between 20-60 deaths among children <5 years of age. With a rotavirus vaccination program now in place, it is important to monitor the epidemiology of rotavirus disease to determine if there are shifts in the genotype distribution, changes in the age distribution (to an older age group) and to examine the effectiveness and duration of protection of rotavirus.