Comparative Effectiveness and Safety of Adjuvanted and Other Influenza Vaccine Technologies Among Patients Receiving Dialysis

佐剂和其他流感疫苗技术在接受透析的患者中的有效性和安全性比较

• 批准号: 10726047
• 负责人: Anne Mobley Butler
• 金额: $ 19.53万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-14 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10726047
• 关键词: Adjuvant; Adjuvant Study; Admission activity; Adult; Adverse event; Advisory Committees; Age; Antibody Response; Antigens; Baculoviruses; Benefits and Risks; Blood Chemical Analysis; Cells; Centers for Disease Control and Prevention (U.S.); Clinical effectiveness; Comparative Study; Data; Databases; Dialysis patients; Dialysis procedure; Disease; Dose; Effectiveness; Emergency department visit; End stage renal failure; General Population; Goals; Health Care Costs; Healthcare; Hemodialysis; Hospitalization; Immune response; Immunization; Immunocompetence; Inactivated Vaccines; Influenza; Influenza prevention; Influenza vaccination; Information Systems; Insecta; Intensive Care Units; Kidney; Licensing; Measures; Methodology; Methods; Morbidity - disease rate; Outcome; Outpatients; Patients; Physicians; Pneumonia; Policies; Population; Prevention approach; Procedures; Provider; Recombinant Vaccines; Recombinants; Recommendation; Relative Risks; Research; Research Design; Respiratory Disease; Risk; Safety; Scientist; Seasons; Serious Adverse Event; Severities; Severity of illness; Subgroup; System; Technology; Time; Time trend; United States; Vaccination; Vaccine Antigen; Vaccinee; Vaccines; Virus; Visit; Vulnerable Populations; adverse event risk; comparative effectiveness; comparative safety; compare effectiveness; effectiveness analysis; effectiveness study; egg; head-to-head comparison; high risk population; individual patient; influenza virus vaccine; mortality; novel vaccines; patient population; prevent; protective effect; response; safety study; seasonal influenza; uptake; vaccination outcome; vaccination strategy; vaccine adverse event; vaccine effectiveness; vaccine evaluation; vaccine formulation; vaccine safety

ABSTRACT Annual influenza vaccination is recommended for patients with ESRD undergoing dialysis by the Advisory Committee on Immunization Practices (ACIP). Non-experimental studies suggest that inactivated, seasonal, standard-dose vaccines are not effective or minimally effective at reducing influenza-related hospitalizations or mortality in the dialysis population, and the high-dose vaccine provides little to no additional protection beyond the standard-dose vaccine for these outcomes. Two vaccine formulations using advanced technologies have been licensed in recent years. The adjuvanted influenza vaccine, licensed in 2015, enhances the magnitude of the immune response to vaccine antigens and broadens the response to include similar mismatched viruses through heterotypic protection. The recombinant influenza vaccine, licensed in 2013 (trivalent) and 2017 (quadrivalent), uses the baculovirus-insect cell system to produce recombinant influenza antigens. Evidence suggests that both the adjuvanted and recombinant influenza vaccines have higher vaccine effectiveness compared to standard-dose vaccines in the general population. Despite increasing uptake of the adjuvanted and recombinant influenza vaccines among the dialysis population in recent years, no large-scale studies have been conducted to evaluate the utilization, effectiveness, or safety of these newly licensed vaccines in the vulnerable population of patients on dialysis. A large study is needed to compare the newly licensed adjuvanted and recombinant vaccines versus other vaccines and to inform influenza prevention approaches in the dialysis population. We propose a large, non-experimental study using existing data from the United States Renal Data System (USRDS) to examine the use, effectiveness, and safety of various influenza vaccines among adult patients with ESRD undergoing dialysis. The large size of our study will allow us to characterize small differences in vaccine effectiveness and safety between adjuvanted or recombinant vaccines vs. standard or high-dose vaccines during the same influenza seasons. Vaccine effectiveness analyses will incorporate a broad range of influenza-related outcomes, including markers of severity of illness. Safety analyses will focus on a priori identified adverse events after influenza immunization. Study design and analyses will use robust methods to measure and account for confounding bias. Our findings will inform dialysis patients and their providers about the risks and benefits of different vaccines and influence vaccine policy, with the ultimate goal of reducing the burden of respiratory disease in this vulnerable population.

抽象的 建议通过咨询的ESRD患者进行年度流感疫苗接种 免疫实践委员会（ACIP）。非实验研究表明，被灭活，季节性， 标准剂量疫苗无效或无效，可以减少与流感相关的住院或 透析人群的死亡率和高剂量疫苗几乎没有任何额外的保护 这些结果的标准剂量疫苗。使用先进技术的两种疫苗制剂具有 近年来获得许可。辅助流感疫苗于2015年获得许可，可提高 对疫苗抗原的免疫反应，并扩大了对包括类似不匹配病毒的反应 通过异型保护。重组流感疫苗，于2013年获得许可（三价）和2017年 （四价），使用杆状病毒诱导细胞系统产生重组流感抗原。证据 表明佐剂和重组流感疫苗都具有较高的疫苗有效性 与普通人群中的标准剂量疫苗相比。尽管增加了佐剂的吸收 近年来透析人群中的重组流感疫苗，没有大规模研究 进行了评估这些新许可疫苗的利用，有效性或安全性 透析患者的脆弱人群。需要进行大量研究来比较新许可的 佐剂和重组疫苗与其他疫苗，并告知预防流感的方法 透析人群。我们使用联合的现有数据提出了一项大型非实验性研究 国家肾脏数据系统（USRDS）检查各种流感的使用，有效性和安全性 ESRD患者的疫苗接受透析。我们的研究的范围将使我们能够 表征辅助或重组之间的疫苗有效性和安全性的微小差异 在同一流感季节，疫苗与标准或高剂量疫苗。疫苗有效性 分析将结合各种与流感相关的结果，包括疾病严重程度的标志。 安全分析将集中于流感免疫后先验确定的不良事件。研究设计和 分析将使用强大的方法来测量和解释混杂的偏见。我们的发现将告知 透析患者及其提供者关于不同疫苗的风险和益处并影响疫苗 政策，最终的目标是减轻这种脆弱人群中呼吸道疾病的负担。