New Vaccine Surveillance Network

摘要 急性呼吸道疾病(ARI)和急性胃肠炎(AGE)是 美国和全球的儿童。这些感染造成了相当大的发病率、死亡率和 除了与休产假有关的间接费用外，还包括直接保健费用。很多情况下 大多数ARI是由病毒引起的，包括流感、呼吸道合胞病毒和其他病毒。同样，大多数人的年龄 在美国与病毒有关，包括轮状病毒和其他。 对于这些疾病，很少或根本没有有效的抗病毒药物，因此接种疫苗是最有希望的 干预。获得许可的疫苗可用于流感和轮状病毒；其他 病原体正在发展中。积极的、前瞻性的监测是建立“现实世界”疫苗所必需的 有效性(VE)。此外，基于人口的监测可以发现潜在的疫苗负担- 并指导政策制定者和工业界。新疫苗提供的基础设施 监测网络(NVSN)将促进这些目标，并允许描述临床 这些疾病的特征、自然历史和种群动态。匹兹堡儿童医院 生防护中心提供一个理想的环境进行拟议的以人口为本的研究，因为生防护中心是唯一 阿勒格尼县和该地区儿科住院和急诊科(ED)护理的主要提供者。 我们提出了三个具体目标。目标1：评估当前OR的有效性和影响(S) 即将推出的疫苗和其他免疫预防战略，并告知儿科疫苗相关 政策。使用试验阴性病例对照方法，计算每年流感和轮状病毒的VE 针对ARI和年龄的医学疫苗。目标2：积极评估年龄和急性呼吸窘迫综合征的负担 (包括经实验室确认的病毒病原体的疾病)。我们将表演 在住院或急诊室登记的患者中ARI和年龄的病毒病因学的实验室确认， 在健康儿童探视中登记的健康对照组。目标3：建立疾病的自然病史 儿科传染病、传播动态、疫苗对目标人群和弱势人群的影响 人口以及可能与公众相关的社会经济和微生物环境 健康干预。我们将收集登记受试者的大量临床和人口学数据，并 健康对照组。受试者将接受其他ARI和年龄相关病毒的测试。 该项目的完成将提供有关许可疫苗的VE的新数据；定义 以人群为基础的潜在疫苗可预防疾病的负担；并建立自然历史和 多种人类病毒的疾病关联。这些结果将指导新疫苗的开发和 抗病毒药物，为公共卫生政策提供信息，并改善美国和全球儿童的健康状况。

Summary Acute respiratory illness (ARI) and acute gastroenteritis (AGE) are leading causes of disease in children in the U.S. and globally. These infections contribute a substantial burden of morbidity, mortality, and direct health care costs, in addition to the indirect costs associated with parental leave from work. Many cases of ARI are caused by viruses, including influenza, respiratory syncytial virus, and others. Similarly, most AGE in the U.S. is associated with viruses, including rotavirus and others. There are few or no effective antivirals for these, and therefore vaccination is the most promising intervention. Licensed vaccines are available for influenza and rotavirus; candidate vaccines for other pathogens are in development. Active, prospective surveillance is necessary to establish “real-world” vaccine effectiveness (VE). Moreover, population-based surveillance can discover the burden of potentially vaccine- preventable diseases and guide policymakers and industry. The infrastructure provided by the New Vaccine Surveillance Network (NVSN) will facilitate these goals, as well as allowing the description of the clinical features, natural history, and population dynamics of these illnesses. The Children’s Hospital of Pittsburgh (CHP) offers an ideal environment to conduct the proposed population-based research, as CHP is the only major provider of pediatric inpatient and Emergency Department (ED) care in Allegheny County and the region. We propose three Specific Aims. Aim 1: To evaluate the effectiveness and impact(s) of current or upcoming vaccines and other immunoprophylaxis strategies, and inform pediatric vaccine-related policies. Using test-negative case-control methods, we will calculate the annual VE of influenza and rotavirus vaccines against medically attended ARI and AGE. Aim 2: To actively assess the burden of AGE and ARI (including illness with laboratory-confirmed viral etiologies) in the pediatric population. We will perform laboratory confirmation of viral etiologies of ARI and AGE among ill subjects enrolled in the inpatient or ED, and healthy controls enrolled at well-child visits. Aim 3: To establish the natural history of disease for pediatric infectious diseases, transmission dynamics, vaccine impacts for targeted and vulnerable populations, and socioeconomic and microbiological environments potentially relevant to public health interventions. We will capture extensive clinical and demographic data on enrolled subjects and healthy controls. Subjects will be tested for additional ARI- and AGE-associated viruses. The completion of this project will provide new data regarding the VE of licensed vaccines; define the population-based burden of potentially vaccine-preventable diseases; and establish the natural history and disease association of multiple human viruses. These results will guide the development of new vaccines and antivirals, inform public health policies, and enhance the health outcomes of children in the U.S. and globally.