MF59佐剂季节性流感疫苗在非老年成年人中的免疫原性和安全性：一项系统评价与荟萃分析。
Immunogenicity and safety of the MF59-adjuvanted seasonal influenza vaccine in non-elderly adults: A systematic review and meta-analysis.
作者信息
Domnich Alexander, Trombetta Carlo-Simone, Fallani Elettra, Salvatore Marco
机构信息
Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, Genoa, Italy.
Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
出版信息
PLoS One. 2024 Dec 30;19(12):e0310677. doi: 10.1371/journal.pone.0310677. eCollection 2024.
OBJECTIVE
In Europe, the age indication for the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) has recently been extended from ≥65 to ≥50 years. Considering that the earliest approval of its trivalent formulation (aTIV) in Italy was for people aged ≥12 years, we aimed to systematically appraise data on the immunogenicity, efficacy, and safety of aTIV/aQIV in non-elderly adults.
METHODS
A systematic literature review was conducted according to the available guidelines and studies were searched in MEDLINE, Biological Abstracts, Web of Science, Cochrane Library and clinical trial registries. Studies on absolute and relative immunogenicity, efficacy, effectiveness, and safety of aTIV/aQIV in non-elderly adults (<65 years) were potentially eligible. These endpoints were analyzed by virus (sub)types and characteristics of vaccinees. Fixed- and random-effects meta-analyses were performed for data synthesis. Protocol registration: CRD42024512472.
RESULTS
Twenty-four publications were analyzed. aTIV/aQIV was more immunogenic than non-adjuvanted vaccines towards vaccine-like strains: the absolute differences in seroconversion rates were 8.8% (95% CI: 3.7%, 14.0%), 13.1% (95% CI: 6.7%, 19.6%) and 11.7% (95% CI: 7.2%, 16.2%) for A(H1N1), A(H3N2), and B strains, respectively. This immunogenicity advantage was more pronounced in immunosuppressed adults. Additionally, aTIV/aQIV was more immunogenic than non-adjuvanted counterparts towards heterologous A(H3N2) strains with a 10.7% (95% CI: 3.2%, 18.2%) difference in seroconversion rates. Data on antibody persistence and efficacy were limited and inconclusive. Overall, aTIV/aQIV was judged safe and well tolerated, although reactogenic events were more frequent in aTIV/aQIV recipients versus comparators. Serious adverse events were uncommon and no difference (risk ratio 1.02; 95% CI: 0.64, 1.63) between aTIV/aQIV and non-adjuvanted formulations was found.
CONCLUSIONS
In non-elderly adults, aTIV/aQIV is safe and generally more immunogenic than non-adjuvanted standard-dose vaccines.
目的
在欧洲，含MF59佐剂的四价流感疫苗（aQIV）的适用年龄最近已从≥65岁扩大至≥50岁。鉴于其在意大利最早获批的三价配方（aTIV）适用于≥12岁的人群，我们旨在系统评估aTIV/aQIV在非老年成年人中的免疫原性、有效性和安全性数据。
方法
根据现有指南进行系统的文献综述，并在MEDLINE、生物学文摘数据库、科学网、考克兰图书馆和临床试验注册库中检索研究。对aTIV/aQIV在非老年成年人（<65岁）中的绝对和相对免疫原性、有效性、效果及安全性的研究可能符合要求。这些终点指标按病毒（亚）型和接种者特征进行分析。采用固定效应和随机效应荟萃分析进行数据合成。方案注册号：CRD42024512472。
结果
分析了24篇出版物。aTIV/aQIV对疫苗类似毒株的免疫原性高于无佐剂疫苗：对于A(H1N1)、A(H3N2)和B毒株，血清转化率的绝对差异分别为8.8%（95%置信区间：3.7%，14.0%）、13.1%（95%置信区间：6.7%，19.6%）和11.7%（95%置信区间：7.2%，16.2%）。这种免疫原性优势在免疫抑制的成年人中更为明显。此外，aTIV/aQIV对异源A(H3N2)毒株的免疫原性高于无佐剂疫苗，血清转化率差异为10.7%（95%置信区间：3.2%，18.2%）。关于抗体持久性和有效性的数据有限且无定论。总体而言，aTIV/aQIV被判定为安全且耐受性良好，尽管与对照相比，aTIV/aQIV接种者的反应原性事件更为频繁。严重不良事件并不常见，且未发现aTIV/aQIV与无佐剂配方之间存在差异（风险比1.02；95%置信区间：0.64，1.63）。
结论
在非老年成年人中，aTIV/aQIV安全，且总体免疫原性高于无佐剂标准剂量疫苗。
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