Journal of Infection最新文献_第7页

Performance of the BIOFIRE® Filmarray Pneumonia Plus Panel for quantifiable bacterial targets compared to semiquantitative culture methods: A systematic review and meta-analysis 与半定量培养方法相比，BIOFIRE®Filmarray Pneumonia Plus Panel在可量化细菌靶标方面的表现：一项系统综述和荟萃分析

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection

Pub Date : 2026-02-01 Epub Date: 2026-01-12 DOI: 10.1016/j.jinf.2026.106683

Estela Giménez , María Ángeles Clari , Eliseo Albert , Nieves Carbonell , David Navarro

This study aimed to assess the association between bacterial loads as quantified by the BIOFIRE® Filmarray Pneumonia Plus Panel (FA-PP) and clinically significant bacterial cultures in different clinical settings, taking into account the type of sample processed and the bacterial targets detected. A comprehensive search was conducted of the PubMed, EMBASE, and Web of Science databases up to November 2024. Pooled odds ratios (ORs) for binned values in genome copies/ml (gc/ml)(10⁴, 10⁵, 10⁶, and ≥10⁷) and their respective 95% confidence intervals (95% CI) are reported throughout the study. Heterogeneity across studies was assessed using the I² statistic. Twenty-three observational studies comprising a total of 4581 patients and 5147 respiratory samples were finally included in the meta-analysis. Overall, pooled ORs for clinically significant culture results were 4.30 (95% CI, 2.53–7.31; P < 0.001) for ≥10⁷ gc/ml, 1.33 (95% CI, 0.70–2.56; P=0.39) for 10⁶, 0.42 (95% CI, 0.20–0.90; P=0.03) for 10⁵, and 0.1⁵ (95% CI, 0.07–0.37; P < 0.001) for 10⁴ gc/ml. Subgroup analyses conducted according to the type of respiratory sample, bacterial target, and hospital admission ward yielded rather similar conclusions. The heterogeneity across studies was very high (I² >80%). Our analyses suggested that values ≥10⁷ gc/ml may be considered reliable indicators of clinically significant bacterial infection. Conversely, 10⁴ gc/ml values likely reflect colonization. Intermediate values (10⁵–10⁶ gc/ml) pose a greater interpretative challenge.

Importance

The FA-PP assay has emerged as an ancillary tool for diagnosing lower respiratory tract infections and adjusting empirical antimicrobial therapies; consequently, it is being increasingly requested by clinicians. The current study fills a critical gap in the interpretation of quantitative data returned by the FA-PP for nosocomial bacterial targets. Assessment of the clinical relevance of FA-PP binned gc/ml values seems mandatory for clinical and therapeutic decision-making processes in patients with severe community-acquired or nosocomial pneumonia. Our analyses showed that values ≥10⁷ gc/ml are consistently associated with a high probability of culture positivity, regardless of the respiratory sample type and the bacterial target considered. In contrast, values of 10⁴ gc/ml likely reflect colonization. Our study emphasizes the need for well-designed and homogeneous studies to gauge the clinical relevance of intermediate FA-PP binned values (10⁵ and 10⁶ gc/ml).

本研究旨在评估由BIOFIRE®Filmarray Pneumonia Plus Panel （FA-PP）量化的细菌负荷与不同临床环境中具有临床意义的细菌培养之间的关系，同时考虑到处理的样品类型和检测到的细菌靶点。对PubMed、EMBASE和Web of Science数据库进行了全面的检索，截止到2024年11月。在整个研究过程中，报告了基因组拷贝数/ml （gc/ml）的合并比值比（or）（104、105、106和≥107）及其各自的95%置信区间（95% CI）。采用I2统计量评估各研究的异质性。23项观察性研究共纳入4581名患者和5147份呼吸样本，最终纳入meta分析。总的来说，临床显著培养结果的合并or值为≥107 gc/ml为4.30 (95% CI, 2.53-7.31; P < 0.001)， 106为1.33 (95% CI, 0.70-2.56； P=0.39)， 105为0.42 (95% CI, 0.20-0.90； P=0.03)， 104 gc/ml为0.15 （95% CI, 0.07-0.37; P < 0.001）。根据呼吸道样本类型、细菌靶点和住院病房进行的亚组分析得出了相当相似的结论。各研究的异质性非常高（I2 >80%）。我们的分析表明，≥107 gc/ml的值可以被认为是临床显著细菌感染的可靠指标。相反，104 gc/ml值可能反映了定殖。中间值（105-106 gc/ml）带来了更大的解释挑战。FA-PP试验已成为诊断下呼吸道感染和调整经验性抗菌治疗的辅助工具；因此，越来越多的临床医生要求它。目前的研究填补了FA-PP为医院细菌靶点返回的定量数据解释的关键空白。评估FA-PP分组gc/ml值的临床相关性对于严重社区获得性或医院源性肺炎患者的临床和治疗决策过程似乎是必要的。我们的分析表明，无论呼吸道样本类型和考虑的细菌靶标如何，≥107 gc/ml的值始终与培养阳性的高概率相关。相比之下，104 gc/ml的值可能反映了定植。我们的研究强调需要精心设计和均匀的研究来衡量中间FA-PP分类值（105和106 gc/ml）的临床相关性。

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引用次数: 0

Dietary zinc ions inhibit virus-induced migrasome formation, potentially reducing viral transmission 膳食锌离子抑制病毒诱导的迁移体形成，潜在地减少病毒传播。

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection

Pub Date : 2026-02-01 Epub Date: 2026-01-08 DOI: 10.1016/j.jinf.2026.106685

Yao Hou, Ang Li, Shuhao Zhang, Mengyang Zhao, Leiliang Zhang

引用次数: 0

Immune profile of T-lymphocytes in pediatric patients recovered of COVID-19: A longitudinal report 儿童COVID-19康复患者t淋巴细胞免疫谱：一项纵向报告。

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection

Pub Date : 2026-02-01 Epub Date: 2026-01-14 DOI: 10.1016/j.jinf.2026.106691

Vera Bain, Isabela Silva-Avelar, Simone Correa-Silva, Olivia M. Matsuo, Yingying Zheng, Andreia Rangel-Santos, Guilherme Souza Gonçalves, Thais de Toledo Fink, Priscila Suguita, Juliana Caires O.A. Ferreira, Arthur Eduardo Fernandes Ferreira, Camila Sanson Yoshino de Paula, Camilla Astley, Fernanda Martins, Magda Carneiro-Sampaio, Heloisa Helena de Sousa Marques, Clovis A. Silva, Patricia Palmeira , Maria Fernanda Bádue Pereira

引用次数: 0

EV-A71 virions are identified in retractosomes, indicating a nonlytic egress for enteroviruses 在收缩体中鉴定出EV-A71病毒粒子，表明肠道病毒的非裂解出口。

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection

Pub Date : 2026-02-01 Epub Date: 2026-01-09 DOI: 10.1016/j.jinf.2026.106690

Xichi Tang , Ang Li , Leiliang Zhang

引用次数: 0

Early diagnosis and treatment of leptospirosis: Optimizing clinical outcomes 钩端螺旋体病的早期诊断和治疗：优化临床结果。

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection

Pub Date : 2026-02-01 Epub Date: 2026-01-10 DOI: 10.1016/j.jinf.2025.106675

Umaporn Limothai , Nattachai Srisawat , David A. Haake

Leptospirosis is a globally prevalent zoonotic infection causing more than one million cases and nearly 60,000 deaths annually yet is often diagnosed late after organ dysfunction and other complications have arisen. Delayed diagnosis leads to late initiation of antibiotics and other therapeutic interventions, at which point complications such as renal failure, jaundice, or pulmonary hemorrhage are more common and therapy is less effective. This review highlights the critical importance of early recognition and intervention, emphasizing the therapeutic window during the leptospiremic phase when antibiotics are most effective. We examine the limitations of current clinical and laboratory diagnostic methods, the evolving role of molecular and biomarker-based platforms, and the potential of integrated scoring systems for frontline triage. Evidence supporting early antibiotic therapy, supportive care strategies, and severity prediction tools is summarized. We propose a paradigm shift toward field-adaptable, point-of-care diagnostics and integrated care pathways to ensure earlier treatment, improved outcomes, and reduced global disease burden.

钩端螺旋体病是一种全球流行的人畜共患感染，每年造成100多万例病例和近6万人死亡，但通常在出现器官功能障碍和其他并发症后才得到诊断。延迟诊断导致抗生素和其他治疗干预措施起步较晚，此时肾衰竭、黄疸或肺出血等并发症更为常见，治疗效果较差。这篇综述强调了早期识别和干预的重要性，强调了抗生素最有效的钩端螺旋体血症期的治疗窗口期。我们研究了当前临床和实验室诊断方法的局限性，基于分子和生物标志物的平台的不断发展的作用，以及一线分诊综合评分系统的潜力。总结了支持早期抗生素治疗、支持性护理策略和严重程度预测工具的证据。我们建议将模式转变为适应现场、即时诊断和综合护理途径，以确保早期治疗、改善结果并减少全球疾病负担。

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引用次数: 0

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection

Pub Date : 2026-02-01 Epub Date: 2026-01-09 DOI: 10.1016/j.jinf.2026.106688

Manon Jaboyedoff , Pierre Alex Crisinel , Zaba Valtuille , Inès Fafi , Margherita Plebani , Yves Fougère , Karim Abawi , Romain Basmaci , Naïm Ouldali , François Angoulvant

Background

Infections remain a leading cause of childhood mortality. Non-pharmaceutical interventions (NPI) implemented during COVID-19 pandemic altered the circulation of communicable pathogens. We aimed to assess how these changes affected paediatric infection-related mortality.

Methods

We conducted a population-based interrupted time-series analysis using national data from France and Switzerland (2015 to 2023), including deaths among individuals <18 years. Monthly infection-related mortality was analysed using quasi-Poisson regression models seasonally adjusted. Mortality rate ratios (MRR) were calculated to compare infection-related mortality among birth cohorts exposed to NPI or post-NPI periods versus pre-NPI cohorts.

Results

Among 32,619 paediatric deaths during the study period, 8272 were related to an infection. During the NPI period, infection-related mortality declined by 16% (95% CI: −23% to −7%), corresponding to an estimated reduction of 221 (95% CI: 90 to 371) deaths. Compared to pre-NPI birth cohorts, 2019 and 2020 cohorts had significantly lower infection-related MRR (0·80, 95% CI 0·66 to 0·98 and 0·80, 95% CI 0·65 to 0·98).

Conclusion

The reduction in paediatric infection-related deaths during the NPI period underscores the ongoing burden of preventable paediatric mortality and suggests that targeted preventive strategies may sustainably reduce infection-related deaths beyond pandemic settings.

背景：感染仍然是儿童死亡的主要原因。在COVID-19大流行期间实施的非药物干预措施改变了传染性病原体的传播。我们的目的是评估这些变化如何影响儿科感染相关死亡率。方法：我们使用法国和瑞士的国家数据（2015年至2023年）进行了基于人群的中断时间序列分析，包括18岁以下个体的死亡。使用准泊松回归模型进行季节性调整，分析每月感染相关死亡率。计算死亡率比率（MRR）以比较暴露于新生儿感染新感染或新生儿感染后与新生儿感染前的出生队列的感染相关死亡率。结果：在研究期间的32,619例儿童死亡中，8272例与感染有关。在新方案实施期间，感染相关死亡率下降了16%(95%置信区间：-23%至-7%)，相当于估计减少221例死亡（95%置信区间：90至371）。与npi前出生队列相比，2019年和2020年队列的感染相关MRR显著降低（0.80,95% CI 0.66至0.98和0.80,95% CI 0.65至0.98）。结论：在新方案实施期间，儿童感染相关死亡的减少强调了可预防的儿童死亡率的持续负担，并表明有针对性的预防战略可以在大流行环境之外持续减少感染相关死亡。

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引用次数: 0

Hypervirulent serotype 1 pneumococci display high levels of nasal shedding and rapid onward transmission 高毒力血清型1肺炎球菌表现出高水平的鼻腔脱落和快速传播。

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection

Pub Date : 2026-01-01 Epub Date: 2025-12-09 DOI: 10.1016/j.jinf.2025.106665

Murielle Baltazar , Laura C. Jacques , Teerawit Audshasai , Marie O'Brien , Aras Kadioglu

Objectives

Streptococcus pneumoniae serotype 1 (S1) is a major cause of invasive pneumococcal disease. Despite its high attack rate, S1 exhibits a low carriage prevalence within the population, which raises questions about the relationship between nasopharyngeal carriage and transmission of hypervirulent strains between individuals. We compared the transmission dynamics of S1 to serotypes 2 (S2) and 3 (S3) using a novel model of transmission in adolescent mice.

Methods

Donor “index” mice were intranasally infected with S1, S2, S3 or isogenic pneumolysin-deficient mutants and co-housed with naïve recipient “contact” mice. Three days later, all mice were infected with influenza A virus (IAV). Pneumococcal transmission was analysed during colonisation alone and co-infection with IAV by quantification of the nasal shedding and nasopharyngeal bacterial density in both index and contact mice. The role of the polysaccharide capsule and toxin pneumolysin, as well as biofilm production in shedding and transmission, and the host nasopharyngeal immune response, were investigated.

Results

We show that S1 was shed at significantly greater levels than S2 and S3 in index mice, which led to significantly higher shedding and transmission rates in contact mice. S1 produced less biofilm and a thick capsule that promoted its increased shedding and transmission. Interestingly, pneumococcal acquisition led to pneumolysin-dependant macrophage recruitment in the nasopharynx of contact mice.

Conclusion

Our results show that rapid and high transmission rate of serotype 1 is a key factor for its success in disseminating quickly within the population and causing outbreaks.

目的：1型肺炎链球菌（S1）是侵袭性肺炎球菌疾病的主要病因。尽管S1的发病率很高，但其在人群中的携带率很低，这就提出了鼻咽携带与高毒菌株在个体之间传播之间关系的问题。我们使用一种新的青少年小鼠传播模型比较了S1与血清型2 （S2）和3 （S3）的传播动力学。方法：供体“指数”小鼠鼻内感染S1、S2、S3或等基因溶血素缺陷突变体，并与naïve受体“接触”小鼠共同饲养。3天后，所有小鼠均感染甲型流感病毒（IAV）。通过定量测定指数小鼠和接触小鼠的鼻腔脱落和鼻咽细菌密度，分析了肺炎球菌在单独定植和与IAV合并感染期间的传播情况。研究了多糖胶囊和毒素溶血素以及生物膜的产生在病毒脱落、传播和宿主鼻咽免疫应答中的作用。结果：我们发现S1在指数小鼠中的脱落量明显高于S2和S3，这导致接触小鼠的脱落和传播率明显高于S2和S3。S1产生较少的生物膜和较厚的荚膜，促进其增加脱落和传播。有趣的是，肺炎球菌获得导致接触小鼠鼻咽部溶血素依赖性巨噬细胞募集。结论：血清1型的快速、高传播率是其在人群中迅速传播并引起疫情的关键因素。

{"title":"Hypervirulent serotype 1 pneumococci display high levels of nasal shedding and rapid onward transmission","authors":"Murielle Baltazar , Laura C. Jacques , Teerawit Audshasai , Marie O'Brien , Aras Kadioglu","doi":"10.1016/j.jinf.2025.106665","DOIUrl":"10.1016/j.jinf.2025.106665","url":null,"abstract":"<div><h3>Objectives</h3><div><em>Streptococcus pneumoniae</em> serotype 1 (S1) is a major cause of invasive pneumococcal disease. Despite its high attack rate, S1 exhibits a low carriage prevalence within the population, which raises questions about the relationship between nasopharyngeal carriage and transmission of hypervirulent strains between individuals. We compared the transmission dynamics of S1 to serotypes 2 (S2) and 3 (S3) using a novel model of transmission in adolescent mice.</div></div><div><h3>Methods</h3><div>Donor “index” mice were intranasally infected with S1, S2, S3 or isogenic pneumolysin-deficient mutants and co-housed with naïve recipient “contact” mice. Three days later, all mice were infected with influenza A virus (IAV). Pneumococcal transmission was analysed during colonisation alone and co-infection with IAV by quantification of the nasal shedding and nasopharyngeal bacterial density in both index and contact mice. The role of the polysaccharide capsule and toxin pneumolysin, as well as biofilm production in shedding and transmission, and the host nasopharyngeal immune response, were investigated.</div></div><div><h3>Results</h3><div>We show that S1 was shed at significantly greater levels than S2 and S3 in index mice, which led to significantly higher shedding and transmission rates in contact mice. S1 produced less biofilm and a thick capsule that promoted its increased shedding and transmission. Interestingly, pneumococcal acquisition led to pneumolysin-dependant macrophage recruitment in the nasopharynx of contact mice.</div></div><div><h3>Conclusion</h3><div>Our results show that rapid and high transmission rate of serotype 1 is a key factor for its success in disseminating quickly within the population and causing outbreaks.</div></div>","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"92 1","pages":"Article 106665"},"PeriodicalIF":11.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145745509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Tuberculosis incidence in solid organ transplant recipients in Europe: A multicenter TBnet cohort study 欧洲实体器官移植受者肺结核发病率：一项多中心TBnet队列研究。

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection

Pub Date : 2026-01-01 Epub Date: 2025-12-20 DOI: 10.1016/j.jinf.2025.106668

Berit Lange , Thomas Theo Brehm , Sandra M. Arend , Miguel Arias-Guillén , Marleen Bakker , Cristina Berastegui , Maaz Babiker , Rawya Charif , Raquel Duarte , Holger Flick , Regina W. Hofland , Joanna Ismail , Daniela Kniepeiss , Jessica Krepel , Nithya Krishnan , Dora L. Kuijpers , Heinke Kunst , Frank van Leth , Visnja Lezaic , Ibai Los-Arcos , Martina Sester

Background

Solid organ transplant (SOT) recipients face elevated tuberculosis risk, yet optimal prevention strategies in low- to medium-incidence regions remain unclear.

Methods

We conducted a multicenter retrospective cohort study of adult SOT recipients transplanted between 2007 and 2012 at 15 European centers, with follow-up through 2018. The primary outcome was microbiologically confirmed post-transplant tuberculosis. Incidence rates were calculated per 100,000 person-years; standardized incidence ratios (SIRs) used World Health Organization country-specific background rates. Cox models assessed risk factors.

Results

Among 5805 patients (median age 51; 62.7% male; 73.9% renal transplants), 33.8% were tested for tuberculosis infection and 10.3% received tuberculosis preventive therapy (TPT). Over 33,785 person-years, 23 patients (0.4%) developed tuberculosis (68.0/100,000 person-years). Highest incidence occurred in patients with positive screening but no TPT (233.8/100,000). Incidence was higher in Southern vs. Central Europe (251.9 vs. 28.7/100,000), with pooled SIRs of 12.8 and 3.1, respectively. Tuberculosis risk was elevated among Southern European recipients (HR 22.9) and those with migration history (HR 2.7).

Conclusion

Tuberculosis risk is increased in European SOT recipients. Regionally adapted prevention strategies, including targeted screening in low-incidence areas and universal screening in higher-incidence regions, are warranted.

背景：实体器官移植（SOT）受者面临更高的结核病风险，但在中低发病率地区的最佳预防策略仍不清楚。方法：我们在欧洲15个中心进行了一项多中心回顾性队列研究，研究对象为2007-2012年间移植的成人SOT受体，随访至2018年。主要结果为微生物学证实的移植后结核。计算每10万人年的发病率；标准化发病率（SIRs）采用世界卫生组织国家特定背景率。Cox模型评估了危险因素。结果：5805例患者（中位年龄51岁，男性62.7%，肾移植73.9%）中，33.8%的患者接受了结核病感染检测，10.3%的患者接受了结核病预防治疗（TPT）。超过33,785人年，23名患者（0.4%）发展为结核病（68.0/100,000人年）。筛查阳性但未接受TPT的患者发病率最高（233.8/10万）。南欧的发病率高于中欧（251.9 vs 28.7/100,000），合并SIRs分别为12.8和3.1。南欧接受者（风险比22.9）和有移民史者（风险比2.7）的结核病风险升高。结论：欧洲SOT受者结核病风险增加。有必要采取适应区域的预防战略，包括在低发病率地区进行有针对性的筛查，在高发病率地区进行普遍筛查。

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引用次数: 0

Epidemiology and clinical characteristics of rat hepatitis E virus infection in humans 人戊型肝炎病毒大鼠感染的流行病学和临床特征

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection

Pub Date : 2026-01-01 Epub Date: 2025-12-18 DOI: 10.1016/j.jinf.2025.106667

Jianwen Situ , Tsz Chung Wong , Shusheng Wu , Zhiyu Li , Estie Hon Kiu Shun , Siu Fung Stanley Ho , Cyril Chik Yan Yip , Kelvin Hon Yin Lo , James Yiu Hung Tsoi , Weihui Ma , Andrew Tsz King Lo , Jayden Yiu , Esmond Yan Tik Ng , Ming Yeung Kwong , Christina Yuen Ling Ip , Hiu Laam Chung , Nicholas Foo Siong Chew , Yonghao Liang , Weiwei Mao , Xiaodan Ma , Siddharth Sridhar

Objectives

Rocahepevirus ratti genotype 1 (rHEV), commonly known as rat hepatitis E virus, is a recently identified cause of viral hepatitis. We compared rHEV infections with conventional hepatitis E and measured rHEV seroprevalence in a large diverse human serum cohort.

Methods

Patients with hepatitis (n=2018) were tested for rHEV RNA in the context of a real-world clinical service in Hong Kong. rHEV IgG seroprevalence in various risk groups was measured using a validated immunoassay. Commensal rats were tested for rHEV RNA and sequences were compared with human-derived strains.

Results

From 2017 to 2025, 22 human rHEV infections were identified. Of these, 14 (63·6%) were immunocompromised compared to 22/78 (28·2%) conventional HEV patients (p<0.01). Hepatitis was milder in rHEV patients, but most immunocompromised rHEV patients progressed to chronic infection. Rat-derived rHEV belonged to two subtypes, one of which infected humans. Of 8294 individuals, 57 (0·7%) tested positive for rHEV IgG compared to 551 (6·6%) for HEV IgG. Increasing age predicted rHEV seropositivity (OR:1·03; 95% CI:1·01–1·05); persons with bloodborne pathogens did not exhibit higher rHEV seroprevalence.

Conclusions

rHEV is a sporadic cause of hepatitis in humans with disproportionate clinical significance for immunocompromised hosts. Although clearly linked to rat epizootics, routes of rHEV transmission remain enigmatic.

目的鼠型罗卡hepevirus ratti基因型1 (rHEV)，俗称大鼠戊型肝炎病毒，是最近发现的病毒性肝炎病因。我们比较了rHEV感染和传统戊型肝炎，并在一个大的不同的人类血清队列中测量了rHEV的血清阳性率。方法在香港的实际临床服务中对肝炎患者（n=2018）进行rHEV RNA检测。使用有效的免疫分析法测量各种危险组的rHEV IgG血清阳性率。对共生大鼠进行rHEV RNA检测，并将序列与人源菌株进行比较。结果2017 - 2025年共发现22例人rHEV感染病例。其中14例（63.6%）出现免疫功能低下，而常规HEV患者中有22/78例（28.2%）出现免疫功能低下（p<0.01）。rHEV患者的肝炎较轻，但大多数免疫功能低下的rHEV患者进展为慢性感染。大鼠衍生的rHEV分两种亚型，其中一种感染人类。在8294人中，57人（0.7%）检测出rHEV IgG阳性，而551人（6.6%）检测出HEV IgG阳性。年龄增加预测rHEV血清阳性（OR: 1.03; 95% CI: 1.01 - 1.05）；血源性病原体的人没有表现出更高的rHEV血清阳性率。结论rhev是人类肝炎的散发病因，在免疫功能低下的宿主中具有不成比例的临床意义。尽管rHEV的传播途径与大鼠动物流行病明显相关，但仍然是一个谜。

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引用次数: 0

Reactogenicity and immunogenicity following heterologous and homologous third dose COVID-19 vaccination in UK adolescents (Com-COV3): A randomised controlled non-inferiority trial 英国青少年异源和同源第三剂COVID-19疫苗（Com-COV3）的反应原性和免疫原性：一项随机对照非劣效性试验

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection

Pub Date : 2026-01-01 Epub Date: 2025-12-01 DOI: 10.1016/j.jinf.2025.106663

E. Kelly , M. Greenland , P. de Whalley , G.C. Macaulay , P.K. Aley , E. Plested , S. Koleva , J. Cotton , J. Kinch , T. Madupuri , R.C. Read , M. Ramsay , C. Cameron , D.P.J. Turner , P. Heath , P. Connor , K. Cathie , S.N. Faust , I. Banerjee , K. Man , X. Liu

Background

The emergence of SARS-CoV2 variants combined with waning vaccine-induced immunity and breakthrough infections has highlighted the need for booster doses to maintain protection against SARS-CoV2 infection and disease.

Methods

Com-COV3 was a phase II, multicentre, randomised controlled trial, recruiting across 11 UK sites from June 2022 to June 2023, with follow-up visits to February 2024. Healthy 12–15-year-olds who had received a two-30 μg dose BNT162b2 primary regimen at least 90 days previously were randomised 1:1:1:1:1 to receive either BNT162b2 30 μg, BNT162b2 10 μg (adult vaccine formulation), BNT162b2 10 μg (paediatric formulation), NVXCoV2373, or Meningococcal B vaccine (control). The primary objective was to determine if SARS-CoV-2 anti-spike antibody following a 10 μg dose of the adult formulation of BNT162b2 was non-inferior to the paediatric formulation at 28 days post-third vaccination. The last five participants were randomised using a 1:3:3:1:1 ratio to prioritise recruitment to the study groups required for the co-primary endpoint. Although recruitment ceased early, the sample size required to fulfil the primary objective was met.

Findings

281 participants were recruited (mean age 14 years old, 57% female). Adverse reactions were mostly mild-to-moderate. Local reactogenicity was mildest following NVXCoV2373. Frequency of adverse events was similar for both full dose and fractional dose BNT162b2 groups. Four serious adverse events occurred: three in the paediatric and one in the adult 10 μg BNT162b2 group. Immunogenicity of 10 μg BNT162b2 (adult) was both non-inferior and superior to that of 10 μg BNT162b2 (paediatric); adjusted geometric mean ratio (aGMR) anti-spike IgG 1.50 (one-sided 95% CI 1.25 to ∞). Compared with 30 μg BNT162b2, anti-spike IgG at day 28 post-third dose were similar in the 10 μg BNT162b2 (adult) group [aGMR 0.93 (95% CI 0.75–1.14)] and significantly lower in the 10 μg BNT162b2 (paediatric) [aGMR 0.64 (95% CI 0.52–0.78)] and NVXCoV2373 [aGMR 0.77 (95% CI 0.63–0.95)] groups. Compared with 30 μg BNT162b2, levels of neutralising antibodies against Omicron BA.5 and XBB.15 were similar across vaccine groups.

Interpretation

All booster regimens evaluated elicited a robust immune response. 10 μg fractional adult BNT162b2 vaccine demonstrated similar immunogenicity compared with 30 μg BNT162b2 and superior immunogenicity compared with 10 μg paediatric BNT162b2 vaccine. Fractional doses of the adult BNT162b2 vaccine are an alternative to the paediatric formulation for booster campaigns in adolescents.

背景：SARS-CoV2变异的出现，加上疫苗诱导的免疫力下降和突破性感染，突出了加强剂量以维持对SARS-CoV2感染和疾病的保护的必要性。方法：Com-COV3是一项II期、多中心、随机对照试验，于2022年6月至2023年6月在英国11个地点招募，随访至2024年2月。至少90天前接受过2- 30μg剂量BNT162b2初级方案的12-15岁健康儿童按1:1:1:1:1随机分组，分别接受BNT162b2 30μg、BNT162b2 10μg（成人疫苗制剂）、BNT162b2 10μg（儿科疫苗制剂）、NVXCoV2373或脑膜炎球菌B疫苗（对照）。主要目的是确定在第三次接种后28天，接种10μg剂量的成人剂型BNT162b2后的SARS-CoV-2抗刺突抗体是否优于儿科剂型。最后5名参与者使用1:3:3:1:1的比例随机分组，优先招募到共同主要终点所需的研究组。虽然征聘工作提前停止，但达到了实现主要目标所需的样本量。结果：281名参与者被招募（平均年龄14岁，57%为女性）。不良反应大多为轻至中度。NVXCoV2373的局部反应性最轻。BNT162b2全剂量组和部分剂量组的不良事件发生率相似。发生了4例严重不良事件：3例发生在儿科，1例发生在10μg BNT162b2成人组。10μg BNT162b2（成人）的免疫原性优于10μg BNT162b2（儿童）；校正几何平均比（aGMR）抗峰值IgG 1.50（单侧95%CI 1.25至∞）。与30μg BNT162b2相比，第3次给药后第28天，10μg BNT162b2（成人）组的抗刺突IgG水平相似[aGMR 0.93 (95%CI 0.75 ~ 1.14)]，而10μg BNT162b2（儿童）组[aGMR 0.64 (95%CI 0.52 ~ 0.78)]和NVXCoV2373 [aGMR 0.77 (95%CI 0.63 ~ 0.95)]的抗刺突IgG水平则显著低于10μg BNT162b2（儿童）组[aGMR 0.64 (95%CI 0.52 ~ 0.78)]。与30μg BNT162b2相比，不同疫苗组抗Omicron BA.5和XBB.15的中和抗体水平相似。解释：所有评估的强化方案都引起了强大的免疫反应。10μg分级成人BNT162b2疫苗与30μg BNT162b2疫苗具有相似的免疫原性，与10μg儿科BNT162b2疫苗具有更强的免疫原性。部分剂量的成人BNT162b2疫苗是用于青少年加强运动的儿科配方的替代方案。资助：国家卫生研究所、疫苗工作组和流行病防范创新联盟。

{"title":"Reactogenicity and immunogenicity following heterologous and homologous third dose COVID-19 vaccination in UK adolescents (Com-COV3): A randomised controlled non-inferiority trial","authors":"E. Kelly , M. Greenland , P. de Whalley , G.C. Macaulay , P.K. Aley , E. Plested , S. Koleva , J. Cotton , J. Kinch , T. Madupuri , R.C. Read , M. Ramsay , C. Cameron , D.P.J. Turner , P. Heath , P. Connor , K. Cathie , S.N. Faust , I. Banerjee , K. Man , X. Liu","doi":"10.1016/j.jinf.2025.106663","DOIUrl":"10.1016/j.jinf.2025.106663","url":null,"abstract":"<div><h3>Background</h3><div>The emergence of SARS-CoV2 variants combined with waning vaccine-induced immunity and breakthrough infections has highlighted the need for booster doses to maintain protection against SARS-CoV2 infection and disease.</div></div><div><h3>Methods</h3><div>Com-COV3 was a phase II, multicentre, randomised controlled trial, recruiting across 11 UK sites from June 2022 to June 2023, with follow-up visits to February 2024. Healthy 12–15-year-olds who had received a two-30 μg dose BNT162b2 primary regimen at least 90 days previously were randomised 1:1:1:1:1 to receive either BNT162b2 30 μg, BNT162b2 10 μg (adult vaccine formulation), BNT162b2 10 μg (paediatric formulation), NVXCoV2373, or Meningococcal B vaccine (control). The primary objective was to determine if SARS-CoV-2 anti-spike antibody following a 10 μg dose of the adult formulation of BNT162b2 was non-inferior to the paediatric formulation at 28 days post-third vaccination. The last five participants were randomised using a 1:3:3:1:1 ratio to prioritise recruitment to the study groups required for the co-primary endpoint. Although recruitment ceased early, the sample size required to fulfil the primary objective was met.</div></div><div><h3>Findings</h3><div>281 participants were recruited (mean age 14 years old, 57% female). Adverse reactions were mostly mild-to-moderate. Local reactogenicity was mildest following NVXCoV2373. Frequency of adverse events was similar for both full dose and fractional dose BNT162b2 groups. Four serious adverse events occurred: three in the paediatric and one in the adult 10 μg BNT162b2 group. Immunogenicity of 10 μg BNT162b2 (adult) was both non-inferior and superior to that of 10 μg BNT162b2 (paediatric); adjusted geometric mean ratio (aGMR) anti-spike IgG 1.50 (one-sided 95% CI 1.25 to ∞). Compared with 30 μg BNT162b2, anti-spike IgG at day 28 post-third dose were similar in the 10 μg BNT162b2 (adult) group [aGMR 0.93 (95% CI 0.75–1.14)] and significantly lower in the 10 μg BNT162b2 (paediatric) [aGMR 0.64 (95% CI 0.52–0.78)] and NVXCoV2373 [aGMR 0.77 (95% CI 0.63–0.95)] groups. Compared with 30 μg BNT162b2, levels of neutralising antibodies against Omicron BA.5 and XBB.15 were similar across vaccine groups.</div></div><div><h3>Interpretation</h3><div>All booster regimens evaluated elicited a robust immune response. 10 μg fractional adult BNT162b2 vaccine demonstrated similar immunogenicity compared with 30 μg BNT162b2 and superior immunogenicity compared with 10 μg paediatric BNT162b2 vaccine. Fractional doses of the adult BNT162b2 vaccine are an alternative to the paediatric formulation for booster campaigns in adolescents.</div></div>","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"92 1","pages":"Article 106663"},"PeriodicalIF":11.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145670432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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