不同技术平台上5种COVID-19疫苗的不良反应特征:9项临床试验的汇总分析

IF 5.5 3区 医学 Q1 IMMUNOLOGY
Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-05-07 DOI:10.1080/14760584.2025.2502031
Yue Liu, Qian Liu, Lai-Run Jin, Wei-Wei Han, Ming-Wei Wei, Si-Yue Jia, Feng-Cai Zhu, Jing-Xin Li
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引用次数: 0

摘要

背景:关于不同COVID-19疫苗相对安全性的证据仍然有限。本研究旨在描述和比较五种COVID-19疫苗免疫后不良反应的安全性。研究设计和方法:我们对9项临床试验中18-59岁成人报告的不良反应进行了回顾性分析。分析的疫苗包括灭活疫苗、重组蛋白疫苗、鼻内流感载体疫苗、雾化疫苗和肌内Ad5载体疫苗。采用因子分析和关联规则分析表征不良反应模式,采用多因素logistic回归评估疫苗类型和人口统计学因素的影响。结果:从“一般疾病和给药部位情况”的SOC来看,灭活疫苗、重组疫苗和肌肉注射Ad5载体疫苗通常会引起注射部位疼痛、疲劳、头痛和发热。鼻内流感载体疫苗主要引起呼吸道症状,如鼻漏和鼻塞,而由“胃肠道疾病”引起的口干和口咽疼痛主要见于雾化的Ad5载体疫苗。结论:通过不同技术方法开发的COVID-19疫苗具有不同的不良反应概况。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adverse reaction characteristics of five COVID-19 vaccines across different technology platforms: a pooled analysis of nine clinical trials.

Background: Evidence regarding the comparative safety of different COVID-19 vaccines remains limited. This study aims to characterize and compare the safety profiles of five COVID-19 vaccines in terms of adverse reactions after immunization.

Research design and methods: We conducted a retrospective analysis of adverse reactions reported among adults aged 18-59 years from nine clinical trials. The analyzed vaccines included inactivated, recombinant protein, intranasal influenza-vectored, aerosolized and intramuscular Ad5 vectored COVID-19 vaccines. Factor analysis and association rule analysis were used to characterize adverse reaction patterns, while multivariate logistic regression was employed to assess the influence of vaccine type and demographic factors.

Results: Inactivated, recombinant, and intramuscular Ad5 vectored vaccines commonly caused injection site pain, fatigue, headache, and pyrexia from the SOC of 'General disorders and administration site conditions.' Intranasal influenza-vectored vaccines mainly cause respiratory symptoms such as rhinorrhea and nasal congestion, while dry mouth and oropharyngeal pain from 'Gastrointestinal disorders' were primarily observed in aerosolized Ad5 vectored vaccines. Younger age (p < 0.001), female sex (p = 0.001), comorbidities (p < 0.001), and intramuscular Ad5 vectored vaccines (p < 0.001) were significantly associated with higher adverse reaction risks.

Conclusions: COVID-19 vaccines developed through different technological approaches have distinct adverse reaction profiles.

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来源期刊
Expert Review of Vaccines
Expert Review of Vaccines 医学-免疫学
CiteScore
9.10
自引率
3.20%
发文量
136
审稿时长
4-8 weeks
期刊介绍: Expert Review of Vaccines (ISSN 1476-0584) provides expert commentary on the development, application, and clinical effectiveness of new vaccines. Coverage includes vaccine technology, vaccine adjuvants, prophylactic vaccines, therapeutic vaccines, AIDS vaccines and vaccines for defence against bioterrorism. All articles are subject to rigorous peer-review. The vaccine field has been transformed by recent technological advances, but there remain many challenges in the delivery of cost-effective, safe vaccines. Expert Review of Vaccines facilitates decision making to drive forward this exciting field.
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