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.

组件A -项目总结/摘要： 流感病毒不断进化，需要每个季节重新配制疫苗。新SARS- CoV-2（SC2）变体在不同地区引起了2019年冠状病毒感染性疾病（COVID）的复发激增 2021年至2022年冬季，美国各地区。估计正在进行的真实世界流感和COVID 针对急性病门诊护理（ACAI）的疫苗有效性（VE）在评估 全国疫苗接种计划提供的保护，以及监测保护期的持续时间 每种疫苗都是履行疾病预防控制中心使命的高度优先事项， 国家健康保护局我们的长期研究目标是促进对 呼吸道病毒（RV）感染的流行病学和预防（即，季节性和大流行性流感，SC2 和其他呼吸道病毒（ORV），如呼吸道合胞病毒[RSV]），同时减少 疾病和改善人民的健康。我们计划系统地评估VE对ACAI 与实验室确认的流感、COVID和疫苗可预防的ORV相关， Baylor Scott &白色健康，德克萨斯州中部（BSWCTX） 人口目的是获得可靠的疫苗接种信息，并提供准确的中期和 在各RV疫苗年龄合格人群中预防ACAI的VE年度估计值。我们的中央 假设是及时和准确地测量VE和由于疫苗可预防疾病负担 房车是可持续的。其原理是，通过评估中期和年度VE对疫苗可预防的 对于RV，CDC ACIP可以修改接受疫苗和加强剂量以及使用 适当的抗病毒药物。具体目标是：1）衡量季节性和大流行性流感的有效性， COVID和针对ACAI的疫苗可预防的ORV疫苗，分别用于实验室确认的轻度至中度 从2022-23年到2026-27年，至少有1,000名儿童和成人感染。2)监测正在进行的流感 和SC2病毒进化通过基因组测序在至少1,000名登记的儿童和成人中进行， 2022-23至2026-27赛季。3)在流感期间进行可能的全年SC2监测 病毒不流通，以测量当前COVID VE对实验室确认的轻度至中度SC2的ACAI 从2022-23到2026-27赛季的儿童和成人感染。为了实现这些目标，我们将 使用测试阴性设计估计门诊环境中的实时VE， BSWCTX负担亚组中疫苗可预防的RV，并检查影响VE的因素。拟议 研究是创新的，因为我们已经调整了方法，包括验证疫苗接种和准确的实验室诊断 在接受系统性筛查的受试者中，RV感染一种或两种流感和SC2 在我们的方法中，使用定义明确的ACAI病例定义， VE和美国中西部流感、COVID和ORV的疾病负担。