RFA-IP-22-004, Component A _ Credible Effectiveness Measures of Seasonal Influenza, COVID-19 and Other Respiratory Virus Vaccines against Ambulatory Care for Acute Illness in Texas (and Component D).

RFA-IP-22-004，组件 A _ 德克萨斯州季节性流感、COVID-19 和其他呼吸道病毒疫苗针对急性疾病门诊护理的可信有效性措施（和组件 D）。

• 批准号: 10698200
• 负责人: Manjusha Gaglani
• 金额: $ 140万
• 依托单位: BAYLOR RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2027-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10698200
• 关键词: RFA; IP; 22; 004; Component

COMPONENT A - PROJECT SUMMARY/ABSTRACT: Influenza (Flu) viruses are constantly evolving, requiring vaccines to be reformulated every season. New SARS- CoV-2 (SC2) variants have caused recurrent Coronavirus Infectious Disease – 2019 (COVID) surges in different regions of the United States through the winter of 2021-22. Estimating ongoing real-world Flu and COVID vaccine effectiveness (VE) against ambulatory care for acute illness (ACAI) are essential in evaluating the protection provided by nationwide vaccination programs and for monitoring the duration of protection afforded by respective vaccines each of which are high priorities for fulfilling the CDC’s mission of serving as the nation’s health protection agency. Our long-term research goal is to advance the understanding of the epidemiology and prevention of respiratory virus (RV) infections (i.e., seasonal and pandemic influenza, SC2 and Other Respiratory Viruses (ORVs) such as Respiratory Syncytial Virus [RSV]) while reducing the burden of disease and improving the health of the population. We plan to systematically evaluate the VE against ACAI associated with lab-confirmed influenza, COVID and vaccine-preventable ORVs with respective CDC recommended vaccinations in the Baylor Scott & White Health, Central Texas (BSWCTX) enrollment eligible population. The objective is to obtain reliable vaccination information and to provide accurate interim and annual estimates of VE to prevent ACAI in respective RV vaccine age-eligible population. Our central hypothesis is that timely and accurate measurement of VE and burden of illness due to vaccine preventable RVs is sustainable. The rationale is that by assessing the interim and annual VE against vaccine preventable RVs, the CDC ACIP can modify recommendations for receiving the vaccines and booster doses as well as use of appropriate antiviral agents. The specific aims are to: 1) Measure effectiveness of seasonal and pandemic Flu, COVID and vaccine-preventable ORV vaccines against ACAI for respective lab-confirmed mild to moderate infection in at least 1,000 children and adults from the 2022-23 to 2026-27 seasons. 2) Monitor ongoing Flu and SC2 viral evolution by genomic sequencing among at least 1,000 enrolled children and adults from the 2022-23 to 2026-27 seasons. 3) Perform potentially year-round SC2 surveillance during periods when Flu viruses are not circulating to measure current COVID VE against ACAI for lab-confirmed mild to moderate SC2 infection in children and adults from the 2022-23 to 2026-27 seasons. To accomplish these aims, we will estimate real-time VE in the ambulatory setting using a test-negative design, estimate burden of illness of vaccine preventable RVs in the BSWCTX burden subset, and examine factors affecting VE. The proposed research is innovative as we have adapted methods to include verified vaccinations and accurate lab diagnosis of RV infections with one or both influenza and SC2 in participants who are systematically screened for eligibility and enrolled using a well-defined ACAI case-definition in our approach, enabling us to aptly measure VE and burden of illness of influenza, COVID, and ORVs in the West South Central United States.

A 部分 - 项目概要/摘要： 流感 (Flu) 病毒不断进化，每个季节都需要重新配制疫苗。 CoV-2 (SC2) 变种已导致不同地区的 2019 年冠状病毒传染病 (COVID) 复发激增 估计 2021-22 年冬季美国各地区正在发生的流感和新冠疫情。 疫苗对急性疾病门诊护理 (ACAI) 的有效性 (VE) 对于评估 全国疫苗接种计划提供的保护以及监测保护持续时间 由各自的疫苗提供，每种疫苗都是履行 CDC 使命的高度优先事项 我们的长期研究目标是增进对国家健康保护机构的了解。 呼吸道病毒 (RV) 感染（即季节性和大流行性流感、SC2）的流行病学和预防 和其他呼吸道病毒 (ORV)，例如呼吸道合胞病毒 [RSV]），同时减轻 我们计划系统地评估 VE 与 ACAI 的关系。 与各自 CDC 实验室确认的流感、COVID 和疫苗可预防的 ORV 相关 德克萨斯州中部 Baylor Scott & White Health (BSWCTX) 注册资格中推荐的疫苗接种 目标是获得可靠的疫苗接种信息并提供准确的临时和准确信息。 我们对 RV 疫苗适龄人群中用于预防 ACAI 的年度估计值进行了评估。 假设是，及时准确地测量 VE 和疫苗引起的疾病负担是可以预防的 RV 是可持续的，其理由是通过评估针对疫苗的临时和年度 VE 可预防。 RV、CDC ACIP 可以修改有关接受疫苗和加强剂量以及使用的建议 适当的抗病毒药物的具体目标是： 1) 测量季节性和大流行性流感的有效性， 针对实验室确诊的轻度至中度 ACAI 的 COVID 和疫苗可预防的 ORV 疫苗 2022-23 至 2026-27 季节至少有 1,000 名儿童和成人感染 2) 监测持续的流感。 SC2 病毒进化，通过基因组测序对至少 1,000 名登记的儿童和成人进行研究 2022-23 至 2026-27 季节 3) 在流感期间进行可能的全年 SC2 监测。 病毒未循环以测量当前的 COVID VE 与 ACAI 的实验室确认的轻度至中度 SC2 2022-23 至 2026-27 赛季儿童和成人感染情况 为了实现这些目标，我们将。 使用测试阴性设计估计动态环境中的实时 VE，估计疾病负担 预防 BSWCTX 子集中的疫苗 RV 负担，并检查影响 VE 的因素。 研究具有创新性，因为我们采用了经过验证的疫苗接种和准确的实验室诊断的方法 在接受系统筛查的人中，感染流感和 SC2 中的一种或两种的 RV 感染率 在我们的方法中使用明确定义的 ACAI 案例定义来确定资格和注册，使我们能够适当地衡量 美国中西部地区的 VE 和流感、COVID 和 ORV 的疾病负担。