RFA-IP-22-004, CORVETS - Cleveland Ohio Respiratory Viruses Vaccines Effectiveness across Traditional Risk Factors and Social Determinants of Health

摘要 克利夫兰大学医院(UHC)建议加入美国评估 季节性流感、新冠肺炎等呼吸道病毒疫苗预防急性呼吸道疾病的研究 流动设置及其CORVETS项目-俄亥俄州克利夫兰呼吸道病毒疫苗的有效性 跨越健康的传统风险因素和社会决定因素。此应用程序是与Case合作的 西部储备大学和路易斯斯托克斯克利夫兰退伍军人医学中心，包括 组成部分A、C、D和E。通过这一伙伴关系，研究小组将能够从种族方面招募 不同来源的人群，并能够获得创新的检测技术。 构成部分A的目标是在至少1,000人中登记和建立一个电子储存库 每年在门诊环境中就医的急性呼吸道病毒病(RVI)患者 在整个研究期间，衡量呼吸道病毒疫苗在儿童和成人中的有效性 实验室确定出现在门诊环境中的医疗护理的急性呼吸道疾病。这个 研究小组将建立和实施包括病毒在内的全面分子诊断平台 呼吸道疾病患者与流感相关的潜在RVI的基因组测序 (IFV)和新冠肺炎来检测和分类病毒变体。 构成部分C目的是查明个人一级和家庭一级的因素 SARS-CoV-2、流感和呼吸道合胞病毒(RSV)的家庭传播，并确定 预防SARS-CoV-2和SARS-CoV-2家庭传播的疫苗接种和抗病毒治疗效果 流行性感冒。为了达到这一目标，我们将进行一项以个案为基础的住户传播研究，以确定 与传播有关的个人和家庭因素。 D部分是将获得疫苗接种前和接种后的财团的样本采集部门。 由研究联合体指定的实验室进行免疫学研究的样本。这些样本可以用来 为了比较不同受试者组中在该成分中测量的免疫反应与 临床疫苗有效性研究A部分中记录的临床观察。这个 C部分活动旨在招募和招收150至200名有资格获得特定 流感和新冠肺炎疫苗，并在接种前和接种后获取样本 全面和详细的既往疫苗史、既往呼吸道疾病史、既往病史和当前 药物。成分D研究使我们能够更好地了解疫苗是如何在 弱势人群，如儿童和老年人以及在接受各种不同 疫苗接种产品和时间表。 E部分的目的是描述和理解个体和群体的差异 使用标准体液和细胞介导性评估对自然流感感染的免疫反应 系统生物学方法，表征和理解季节性免疫原性的异质性 使用标准和系统在疾控中心/联盟选定的感兴趣人群中接种流感疫苗 生物学方法，并使用标准体液和细胞介导的评估来表征 疾控中心/联盟选定的替代流感疫苗类型和策略的免疫原性，以及 通过系统生物学的方法报告和机械地剖析这些结果。

Abstract University Hospitals of Cleveland (UHC) proposes to join the US Platform Measuring Effectiveness of Seasonal Influenza, COVID-19 and other Respiratory Virus Vaccines for the Prevention of Acute Illness in Ambulatory Settings with its project CORVETS - Cleveland Ohio Respiratory Viruses Vaccines Effectiveness across Traditional Risk Factors and Social Determinants of Health. This application is in partnership with Case Western Reserve University and the Louis Stokes Cleveland VA Medical Center and includes Components A, C, D and E. Through this partnership, the study team will be able to recruit from a racially diverse source population and have access to innovative testing technologies. The aims for Component A are to enroll and establish an electronic repository on at least 1,000 patients annually with medically attended acute respiratory viral illness (RVI) in the ambulatory setting throughout the study period to measure the effectiveness of respiratory virus vaccines in children and adults on laboratory ascertained medically attended acute respiratory illness presenting to an ambulatory setting. The study team will establish and implement a comprehensive molecular diagnostic platform including viral genomic sequencing of patients experiencing respiratory illness for underlying RVIs associated with influenza (IFV) and COVID-19 to detect and catalog viral variants. The aim for Component C is to identify individual level and household-level factors that contribute to household transmission of SARS-CoV-2, influenza, and respiratory syncytial virus (RSV) and determine the effectiveness of vaccination and antiviral treatment in preventing household transmission of SARS-CoV-2 and influenza. To accomplish this aim, we will conduct a case-ascertained household transmission study to identify individual-level and household-level factors associated with transmission. Component D is a sample acquisition arm of the consortium that will obtain pre- and post-vaccination samples for immunologic study by the study consortium’s designated laboratory. These samples can be used to compare the immune responses measured in this component in the various subject groups with the with the clinical observations noted in the Component A arm of the study on clinical vaccine effectiveness. The component C activities aim to recruit and enroll 150 to 200 subjects who are eligible to receive specific influenza and COVID-19 vaccines and obtain samples pre- and post-vaccination in addition to a comprehensive and detailed history of prior vaccines, prior respiratory illness, past medical history, and current medications. Component D studies enable us to gain a better understanding of how vaccines work in vulnerable populations such as children and the elderly as well as in subjects receiving a variety of different vaccination products and schedules. The aims of Component E are to characterize and understand individual and population differences in immune response to natural influenza infections using standard humoral and cell-mediated assessment and systems biology methods, to characterize and understand the heterogeneity in immunogenicity to seasonal influenza vaccines in the CDC/consortium-selected population groups of interest using standard and systems biology methods, and to use standard humoral and cell-mediated assessment to characterize the immunogenicity of the CDC/consortium-selected alternative influenza vaccine types and strategies, and to report and mechanistically dissect these results via a systems biology approach.