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: 8231926
• 负责人: Manjusha Gaglani
• 金额: $ 69.51万
• 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/8231926
• 关键词: Core_RT; PCR; based; Case; Control

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：流感病毒不断变化，疫苗每年都会重新配制。准确评估流感疫苗预防流感感染的有效性对于评估年度全国性疫苗接种计划提供的保护至关重要。发现更先进的策略来衡量疫苗的有效性将有可能减少流感的总体负担，同时改善人口的健康。我们计划在Scott和白色医疗保健-坦普尔人口研究区（SWH-TPRA）来源人群中，系统地评价流感疫苗与ACIP推荐的6个月或以上人群的普遍免疫策略的有效性。我们的目标是利用我们独特的研究经验，探索目前的方法来衡量疫苗对实验室确认的流感（VE-LCI）的有效性，并确定，实施和评估创新的，可行的和可持续的战略，以衡量VE-LCI在所有人年龄6个月或以上的门诊急性护理环境。我们的中心假设是，及时有效地测量VE-LCI在美国是可行的和可持续的。这一假设将通过追求三个具体目标进行测试：1）确定创新、可行和可持续的策略，以及时有效的方式测量6个月或以上在门诊急性护理环境中寻求急性呼吸道疾病（ARI）护理的患者的VE-LCI，2）实施创新、可行和可持续的策略，以及时有效地测量6个月或以上在门诊急诊护理环境中寻求ARI护理的患者的VE-LCI，以及3）评价创新、可行和可持续的策略，以及时有效地测量6个月或以上在门诊急诊护理环境中寻求ARI护理的患者的VE-LCI。为了实现这些目标，将在6个月至18岁的儿童、19-49岁的成人和50岁或以上的患者中确定VE-LCI，这些患者在SWH-TPRA门诊急性护理环境中具有明确的ARI簇，并且通过RT-PCR检测甲型或B型流感病毒呈阳性，在调整混杂因素后，通过比较他们接种流感疫苗的几率与年龄匹配的流感RT-PCR检测阴性的对照组。在2011-2012年至2015-2016年期间，来自SWH-TPRA来源人群的在SWH患有PCP并在流感流行期间在SWH-TPRA门诊、急诊或急诊科出现ARI聚集的人员将有资格参加本CDC VE-LCI研究，采用滚动4小时区组招募策略，最大限度地减少选择偏倚。使用RT-PCR证实的病例对照设计，我们将在所有6个月或以上的人中测量VE-LCI。将计算RT-PCR确认病例和RT-PCR阴性对照的流感疫苗接种率，调整VE-LCI的混杂因素。拟议的研究是创新的，因为它将极大地帮助理解VE-LCI的及时和有效措施，也将确定扩大和增加流感免疫对疾病负担的公共卫生影响的有效措施。