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 建议接受透析的 ESRD 患者每年接种流感疫苗 免疫实践委员会 (ACIP)。非实验研究表明，灭活的、季节性的、 标准剂量疫苗在减少流感相关住院治疗方面无效或效果甚微，或 透析人群的死亡率，高剂量疫苗几乎没有提供额外的保护 针对这些结果的标准剂量疫苗。两种采用先进技术的疫苗配方 近年来获得许可。佐剂流感疫苗于 2015 年获得许可，增强了流感疫苗的预防效果 对疫苗抗原的免疫反应，并将反应范围扩大到包括类似的错配病毒 通过异型保护。重组流感疫苗，于 2013 年（三价）和 2017 年获得许可 （四价），使用杆状病毒-昆虫细胞系统生产重组流感抗原。证据 表明佐剂流感疫苗和重组流感疫苗均具有更高的疫苗效力 与一般人群中的标准剂量疫苗相比。尽管佐剂的摄入量不断增加 近年来，在透析人群中使用重组流感疫苗，尚未开展大规模研究 已进行评估这些新许可疫苗的利用、有效性或安全性 接受透析的患者的弱势群体。需要进行一项大型研究来比较新许可的 佐剂和重组疫苗与其他疫苗的比较，并为流感预防方法提供信息 透析人群。我们建议使用来自美国的现有数据进行一项大型非实验研究 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 接受透析的 ESRD 成年患者接种疫苗。我们的大规模研究将使我们能够 表征佐剂或重组疫苗之间在有效性和安全性方面的微小差异 同一流感季节期间接种的疫苗与标准或高剂量疫苗的比较。疫苗有效性 分析将纳入广泛的流感相关结果，包括疾病严重程度的标志。 安全性分析将重点关注流感免疫后先验确定的不良事件。研究设计和 分析将使用稳健的方法来衡量和解释混杂偏差。我们的研究结果将告知 透析患者及其提供者了解不同疫苗的风险和益处以及对疫苗的影响 政策的最终目标是减轻这一弱势群体的呼吸道疾病负担。