Core_RT-PCR based Case-Control: Apt Measure of Influenza Vaccine Effectiveness

基于 Core_RT-PCR 的病例对照：流感疫苗有效性的恰当测量

• 批准号: 8705908
• 负责人: Manjusha Gaglani
• 金额: $ 94.5万
• 依托单位: SCOTT AND WHITE MEMORIAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8705908
• 关键词: Core_RT; PCR; based; Case; Control

Influenza viruses are constantly changing and vaccines are reformulated every year. Accurately estimating influenza vaccine effectiveness to prevent influenza infection is critical in order to evaluate the protection provided by annual, nationwide vaccination programs. The discovery of more advanced strategies to measure vaccine effectiveness will potentially reduce the overall burden of influenza while improving the health of the population. We plan to systematically evaluate the effectiveness of influenza vaccines with the ACIP recommended universal immunization strategy for persons ages 6 months or older in the Scott and White Healthcare-Temple Population Research Area (SWH-TPRA) source population. Our objective is to use our singular research experience to explore current methodologies to measure vaccine effectiveness against lab- confirmed influenza (VE-LCI), and identify, implement and evaluate innovative, feasible, and sustainable strategies for measuring VE-LCI in all persons ages 6 months or older in outpatient acute care settings. Our central hypothesis is that timely and efficient measurement of VE-LCI is feasible and sustainable in the U.S. This hypothesis will be tested by pursuing three specific aims: 1) Identify innovative, feasible, and sustainable strategies to measure VE-LCI in a timely and efficient manner for persons of ages 6 months or older seeking care for an acute respiratory illness (ARI) in outpatient acute care settings, 2) Implement innovative, feasible and sustainable strategies to measure VE-LCI in a timely and efficient manner for persons 6 months or older seeking care for an ARI in outpatient acute care settings, and 3) Evaluate innovative, feasible and sustainable strategies to measure VE-LCI in a timely and efficient manner for persons 6 months or older seeking care for an ARI in outpatient acute care settings. To accomplish these goals, VE-LCI will be determined in children ages 6 months - 18 years, adults ages 19-49 years and those 50 years or older who present at SWH-TPRA outpatient acute care setting with a well-defined ARI cluster and test positive for influenza A or B by RT-PCR assay, by comparing their odds of being vaccinated against influenza with age-matched controls who had a negative influenza RT-PCR assay, after adjusting for confounders. During 2011-2012 through 2015-2016, persons from the SWH-TPRA source population, who have a PCP at SWH, and present with an ARI cluster during the influenza epidemic period at a SWH-TPRA outpatient clinic, urgent care or emergency department, will be eligible to participate in this CDC VE-LCI study, using a rolling 4 hour block recruitment strategy minimizing selection bias. Using RT-PCR confirmed case-control design, we will measure VE-LCI in all persons ages 6 months or older. Influenza immunization rates will be calculated for the RT-PCR confirmed cases and RT-PCR negative controls, adjusting VE-LCI for confounders. The proposed research is innovative, because it will greatly help understand timely and efficient measures of VE-LCI and will also define effective measures of the public health impact of expanded and increasing influenza immunization on burden of illness.

流感病毒不断变化，疫苗每年都会重新配制。准确估计 流感疫苗预防流感感染的有效性对于评估保护作用至关重要 由年度全国疫苗接种计划提供。发现更先进的测量策略 疫苗的有效性将有可能减轻流感的总体负担，同时改善人们的健康 人口。我们计划通过 ACIP 系统评估流感疫苗的有效性 Scott 和 White 地区推荐的针对 6 个月或以上人群的普遍免疫策略 医疗保健-寺庙人口研究区 (SWH-TPRA) 来源人口。我们的目标是利用我们的 独特的研究经验探索当前的方法来衡量疫苗对实验室的有效性 确认流感（VE-LCI），并确定、实施和评估创新、可行和可持续的 在门诊急症护理机构中测量 6 个月或以上所有人群 VE-LCI 的策略。我们的 中心假设是，及时有效地测量 VE-LCI 在美国是可行且可持续的。 该假设将通过追求三个具体目标来检验：1）确定创新、可行和可持续的目标 为 6 个月或以上年龄的人及时有效地测量 VE-LCI 的策略 在门诊急性护理环境中护理急性呼吸系统疾病 (ARI)，2) 实施创新、可行的措施 以及及时有效地测量 6 个月或以上人群 VE-LCI 的可持续策略 在门诊急性护理环境中寻求 ARI 护理，以及 3) 评估创新、可行和可持续 为 6 个月或以上寻求护理的人及时有效地测量 VE-LCI 的策略 门诊急症护理环境中的 ARI。为了实现这些目标，将确定儿童的 VE-LCI 年龄 6 个月至 18 岁、年龄 19-49 岁的成人以及 50 岁或以上出席 SWH-TPRA 的人士 具有明确 ARI 簇且通过 RT-PCR 检测出甲型或乙型流感阳性的门诊急症护理环境 分析，通过比较他们接种流感疫苗的几率与年龄匹配的对照组 调整混杂因素后，流感 RT-PCR 检测结果呈阴性。 2011-2012 年至 2015-2016 年期间， 来自 SWH-TPRA 源人群、在 SWH 拥有 PCP 并出现 ARI 集群的人 在流感流行期间，在 SWH-TPRA 门诊、紧急护理或急诊室， 将有资格参加这项 CDC VE-LCI 研究，采用滚动 4 小时批量招募策略 最大限度地减少选择偏差。使用 RT-PCR 确认的病例对照设计，我们将测量所有患者的 VE-LCI 年龄 6 个月或以上的人。将根据 RT-PCR 确认的结果计算流感免疫率 病例和 RT-PCR 阴性对照，调整 VE-LCI 的混杂因素。所提出的研究具有创新性， 因为它将极大地帮助了解及时有效的 VE-LCI 措施，并且还将定义有效的措施 衡量扩大和增加流感免疫接种对疾病负担的公共卫生影响。