Annual Estimates of Influenza Vaccine Effectiveness for Preventing Laboratory-Con

流感疫苗预防实验室骗局有效性的年度估计

• 批准号: 7669361
• 负责人: ARNOLD S MONTO
• 金额: $ 149.29万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7669361
• 关键词: Annual; Estimates; Influenza; Vaccine; Effectiveness

DESCRIPTION (provided by investigator): Because of absolute recommendation for annual vaccination for the most vulnerable populations (the elderly), only observational studies of vaccine effectiveness can be carried out among them for ethical reasons. Results from observational studies may be inaccurate due to unrecognized selection biases. Study design strategies to identify and adjust for these biases are necessary. The proposed observational study includes such strategies including laboratory- confirmation of medically attended influenza-like illnesses (ILI) as influenza, planned effectiveness estimates within and outside of surveillance defined periods of influenza circulation and new strategies to adjust for missing information that results in misclassification of outcome measures. Our primary objective is to assess annual effectiveness of licensed influenza vaccines in preventing laboratory-confirmed medically-attended influenza, including influenza-related complications. This assessment requires (1) identification of patient cohorts that are followed for outpatient health care contacts for acute respiratory illness (ICD-9-CM 460- 466) or pneumonia and influenza (ICD-9-CM 480-487), and hospitalization for pneumonia and influenza (ICD-9-CM codes 480-487); (2) collection of specimens from ill patients and laboratory processing of specimens using viral culture and real time PCR methods to confirm respiratory illnesses as influenza; (3) determination and validation of influenza vaccination status of cohort members; and (4) implementing a mechanism such that preliminary data for interim effectiveness estimates are available during the influenza season, with complete data available for summary analyses and publication by September following annual influenza seasons. Our secondary objective (5) is to recruit, vaccinate and collect paired pre- and post-vaccination blood specimens from 300-450 participants, 65 years and older, for assessment of the serologic (up to 450 participants) and cell-mediated (up to 150 participants) immune responses to influenza vaccination. All participants will receive a single dose of a licensed inactivated vaccine (timed appropriately for seasonal protection); paired blood specimens will be collected at pre- and 30-day post-vaccination visits, required immediate specimen processing performed and specimens stored in appropriate repositories until shipped to reference labs for testing.

描述（由研究者提供）：由于绝对建议最脆弱人群（老年人）每年接种疫苗，出于伦理原因只能对他们进行疫苗有效性的观察性研究。由于未认识到选择偏差，观察性研究的结果可能不准确。研究设计策略来识别和调整这些偏差是必要的。拟议的观察性研究包括这样的策略，包括实验室确认医疗处理的流感样疾病（ILI）为流感、在规定的流感传播监测期间内和之外进行计划的有效性估计，以及调整导致结果测量错误分类的缺失信息的新策略。我们的主要目标是评估获得许可的流感疫苗在预防实验室确诊的就医流感（包括流感相关并发症）方面的年度有效性。该评估要求 (1) 确定因急性呼吸道疾病 (ICD-9-CM 460-466) 或肺炎和流感 (ICD-9-CM 480-487) 以及因肺炎和流感住院 (ICD-9-CM 代码 480-487) 住院的门诊医疗接触者的患者队列； (2) 采集患者标本，并利用病毒培养和实时PCR方法对标本进行实验室处理，以确认呼吸道疾病为流感； (3) 队列成员流感疫苗接种状况的确定和验证； (4) 实施一种机制，以便在流感季节期间提供中期有效性估计的初步数据，并在每年流感季节之后的 9 月份之前提供用于总结分析和发布的完整数据。我们的次要目标 (5) 是从 300-450 名 65 岁及以上参与者中招募、接种疫苗并收集配对的疫苗接种前和疫苗后血液样本，以评估流感疫苗接种的血清学（最多 450 名参与者）和细胞介导（最多 150 名参与者）免疫反应。所有参与者将接受一剂经许可的灭活疫苗（针对季节性保护适时安排）；配对的血液样本将在疫苗接种前和疫苗接种后 30 天的访视时采集，需要立即进行样本处理，并将样本储存在适当的储存库中，直到运送到参考实验室进行测试。