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Immunogenicity and safety of MVA-BN vaccine administered 5 years after a two-dose primary series in DR Congo: a prospective cohort study 刚果民主共和国首次接种两剂MVA-BN疫苗5年后的免疫原性和安全性:一项前瞻性队列研究
IF 56.3 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2026-03-09 DOI: 10.1016/s1473-3099(26)00001-0
Lalita Priyamvada PhD, Faisal S Minhaj PharmD, Toutou Likafi MScN, Elisabeth Pukuta MSc, Elisabeth Muyamuna BSc, William C Carson BSc, Margaret Moriarty BSc, Sergio Rodriguez PhD, Taina Joseph MPH, Joelle Kabamba MD, Gaston Kokola BSc, Robert Shongo Lushima MD, Jean-Jacques Muyembe-Tamfum MD, Christine M Hughes MPH, Brett W Petersen MD, Yon Yu PharmD, Agam Rao MD, Andrea M McCollum PhD, Prof Didine K Kaba MD, Beatrice U Nguete MD, Panayampalli S Satheshkumar PhD, Michael B Townsend PhD
The expanding mpox outbreak in Africa and travel-associated cases in other continents have increased efforts to vaccinate populations at high risk. This study aimed to assess serological immune responses 5 years after individuals received a primary vaccination (two-dose series) with the smallpox and mpox vaccine modified vaccinia Ankara-Bavarian Nordic (MVA-BN), as well as to evaluate the safety and immunogenicity of a third dose (booster). To date, there are no data for immunological memory or third-dose-induced immunity for MVA-BN at these long-term timescales.
非洲不断扩大的麻疹疫情以及其他大陆与旅行有关的病例加大了为高危人群接种疫苗的努力。本研究旨在评估个体接受安卡拉-巴伐利亚北欧(MVA-BN)天花和m痘改良牛痘(MVA-BN)初次接种(两剂系列)5年后的血清学免疫应答,以及评估第三剂(加强剂)的安全性和免疫原性。迄今为止,还没有MVA-BN在这些长期时间尺度上的免疫记忆或第三剂量诱导免疫的数据。
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引用次数: 0
Case presentation of patients hospitalised with mpox (subclade Ib/2023sh) including children, adolescents, and adults in South Kivu, Democratic Republic of the Congo: an observational cohort study 刚果民主共和国南基伍省因m痘(亚型Ib/2023sh)住院患者的病例介绍:一项观察性队列研究
IF 56.3 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2026-03-09 DOI: 10.1016/s1473-3099(26)00051-4
Luis Flores Girón MSc, Gustavo Sganzerla Martinez PhD, Baganda Ntahuma Daniel MD, Alfred Kesheni Bisimwa MD, Nkonzi Pacific MD, Georges Assumani Martin BVSc, Jean Christian Amini Kabwana BSc, Anuj Kumar PhD, Ali Toloue Ostadgavahi MSc, Mansi Dutt MSc, Kawaya Lusante Bénite BSc, Mangura Hamuli Damien BSc, Prof Christian Gortázar PhD, Bahaa Abu-Raya PhD, Alyson A Kelvin PhD, Kaleme Kiswele Prince PhD, Prof David J Kelvin PhD
Mpox is a public health concern in eastern DR Congo. It continues to cause substantial numbers of hospital admissions, with changing demographics including children and adolescents, requiring comprehensive clinical and epidemiological investigation. In this study, we aim to describe the clinical characteristics of hospitalised participants infected with monkeypox virus (MPXV) subclade Ib/2023sh in the Kabare Territory in South Kivu, DR Congo.
麻疹是刚果民主共和国东部的一个公共卫生问题。随着包括儿童和青少年在内的人口结构的变化,它继续造成大量住院人数,需要进行全面的临床和流行病学调查。在这项研究中,我们的目的是描述刚果民主共和国南基伍卡巴雷地区感染猴痘病毒(MPXV)亚支Ib/2023sh的住院参与者的临床特征。
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引用次数: 0
A combined ELISA for infection-induced and vaccine-induced mpox antibodies during the clade Ib outbreak in Rwanda: an observational, cross-sectional, clinical validation study 在卢旺达b支枝暴发期间,用于检测感染诱导和疫苗诱导m痘抗体的联合ELISA:一项观察性、横断面、临床验证研究
IF 56.3 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2026-03-09 DOI: 10.1016/s1473-3099(26)00006-x
Jenny Clarke, Herve Semukunzi, Sian E Faustini, Jennifer L J Heaney, Hin Fai Kwok, Jean Marie Vianney Uwimana, Karishma Gokani, Gilbert Rukundo, Jean Pierre Musabyimana, Prosper Ingabire, Leopold Bitunguhari, Jean de Dieu Harelimana, Alex G Richter, Claude M Muvunyi, Christopher A Green
<h3>Background</h3>Validated serological assays for mpox are scarce, particularly in outbreak regions where they are most urgently needed. We aimed to conduct an in-country validation of a serum-based mpox IgG ELISA during an outbreak of clade Ib mpox in Rwanda, and report immunological observations after infection and vaccination and on background seropositivity.<h3>Methods</h3>This observational, cross-sectional, clinical validation study of an mpox-specific IgG ELISA was conducted at the Rwanda National Reference Laboratory, within the Rwanda Biomedical Centre, Kigali, Rwanda. Adults (aged ≥18 years) were recruited into one of three groups of equal size: those who had previously had a microbiologically confirmed mpox infection (the infection cohort), those who had previously received an mpox vaccination (the vaccination cohort), and individuals with no history of mpox infection or vaccination (the unexposed cohort). Venous blood and dried blood spot (DBS) samples were collected from the participants. The IgG assay, containing four immunodominant mpox antigens, was developed into plate-based ELISA kits and used to analyse the serum and DBS samples, and an IgG ratio was obtained from the optical density readout. The performance of the assay was assessed by analysis of the receiver operating characteristic curve, intra-assay and interassay precision, and linearity, and the agreement between serum and DBS concentrations was tested with Spearman's correlation and Bland–Altman analysis.<h3>Findings</h3>Between Aug 1 and Aug 12, 2025, 194 individuals were invited to participate in the study, of whom 150 were enrolled, 50 in each of the three cohorts. Median IgG ratios were 3·24 (IQR 1·33–8·01) in the infection cohort, 1·77 (0·90–2·86) in the vaccination cohort, and 0·68 (0·39–1·16) in the unexposed cohort. IgG ratios in the infection and vaccination cohorts overlapped, but were both significantly higher than in the unexposed cohort (p<0·0001 for the infection cohort; p=0·0002 for the vaccination cohort). Intra-assay (coefficient of variation ≤13%) and interassay (≤10%) precision was high, and ratios were linear across dilutions. DBS and serum measurements were strongly correlated (<em>R</em><sup>2</sup>=0·84), but DBS measurements showed a small underestimation. In the vaccination cohort, IgG ratios were higher in female participants (median 2·70 [IQR 0·83–3·77], n=21) than in male participants (1·35 [0·90–2·42], n=29; p=0·0030).<h3>Interpretation</h3>We show that an mpox ELISA can be implemented within a national reference laboratory in a resource-limited setting as part of outbreak-response measures. The assay is suitable for population-level surveys and can analyse both DBS and serum samples. These findings provide a platform for larger population studies and further work to explore immune correlates of protection in mpox.<h3>Funding</h3>United Nations Environment Programme and the UK Department for Environment, Food and Rural Affairs; East Afr
经过验证的m痘血清学检测方法很少,特别是在最迫切需要这些检测方法的暴发地区。我们的目的是在卢旺达发生b支mpox暴发期间对基于血清的mpox IgG ELISA进行国内验证,并报告感染和疫苗接种后的免疫学观察结果以及背景血清阳性。方法在卢旺达基加利卢旺达生物医学中心的卢旺达国家参考实验室进行了一项观察性、横断性、临床验证的免疫吸附试验。成年人(年龄≥18岁)被招募到三个大小相等的组中:先前有微生物学证实的m痘感染(感染组),以前接受过m痘疫苗接种(疫苗接种组),以及没有m痘感染或疫苗接种史的个体(未暴露组)。采集受试者静脉血和干血斑(DBS)标本。IgG检测包含四种免疫优势m痘抗原,开发成基于板的ELISA试剂盒,用于分析血清和DBS样品,并从光密度读数获得IgG比例。通过分析受试者工作特征曲线、测定内、测定间精密度和线性度来评价该方法的性能,并采用Spearman相关分析和Bland-Altman分析检验血清和DBS浓度之间的一致性。研究结果:在2025年8月1日至8月12日期间,194人被邀请参加了这项研究,其中150人入选,三个组各50人。感染组IgG比值中位数为3.24 (IQR为1.33 - 8.01),接种组为1.77 (IQR为0.90 - 2.86),未暴露组为0.68 (IQR为0.39 - 1.16)。感染组和接种组的IgG比值重叠,但均显著高于未暴露组(p = 0.0001,感染组p= 0.0002)。测定内(变异系数≤13%)和测定间(≤10%)精密度高,各稀释度的比值呈线性。DBS与血清测量值呈强相关(R2= 0.84),但DBS测量值有轻微低估。在疫苗接种队列中,女性受试者的IgG比值(中位数2.70 [IQR 0.83 - 3.77], n=21)高于男性受试者(中位数1.35 [0.90 - 2.42],n=29; p= 0.0030)。我们表明,作为疫情应对措施的一部分,m痘ELISA可以在资源有限的国家参考实验室中实施。该检测方法适用于人群水平的调查,可以分析脑起搏器和血清样本。这些发现为更大规模的人群研究和进一步探索m痘保护的免疫相关因素提供了平台。为联合国环境规划署和英国环境、食品和农村事务部提供资金;东非共同体疫苗、免疫和保健供应链管理区域卓越中心;医学研究理事会;和英国研究中心。有关摘要的卢旺达语翻译,请参阅补充资料部分。
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引用次数: 0
From emergency to integration: research as the bridge in mpox control 从紧急到综合:研究作为麻疹控制的桥梁
IF 56.3 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2026-03-09 DOI: 10.1016/s1473-3099(26)00121-0
Yap Boum, Mosoka Fallah, Michel Muteba, Henry Kyobe Bosa, Kyeng Mercy, John Misaki Wayengera, Bruce Kirenga, John Otshudiema, Placide Mbala, Marie-Roseline Belizaire, Ngashi Ngongo, Jean Kaseya
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引用次数: 0
Safety of MVA-BN vaccine in health-care personnel in DR Congo: a prospective cohort study MVA-BN疫苗在刚果民主共和国卫生保健人员中的安全性:一项前瞻性队列研究
IF 56.3 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2026-03-09 DOI: 10.1016/s1473-3099(25)00779-0
Faisal S Minhaj, Anna Mandra, Béatrice U Nguete, Toutou Likafi, Gaston Kokola, Stephanie Tran, Jordan L Kennedy, Benjamin Monroe, Christine M Hughes, Taina Joseph, Marissa K Person, Michael B Townsend, Panayampalli S Satheshkumar, Joelle Kabamba, Mary G Reynolds, Agam K Rao, Dorah Kasongo, Patricia A Yu, Yon Yu, Robert Shongo Lushima, Andrea M McCollum
<h3>Background</h3>Modified vaccinia Ankara-Bavarian Nordic (MVA-BN) is a third-generation, replication-deficient, smallpox and mpox vaccine that is prepared in liquid and lyophilised formulations. DR Congo reports the highest number of mpox cases annually. Safety data on MVA-BN are available from high-income countries, but comprehensive safety evaluations of MVA-BN are limited in the African continent.<h3>Methods</h3>From Feb 23 to Aug 29, 2017, and from Aug 15 to Sept 17, 2019, 1600 adult (aged 18 years and older) health-care personnel (eg, physicians, nurses, and technicians) at risk for mpox in the Tshuapa province and in Kinshasa were enrolled in an investigational prospective cohort study to evaluate safety of the two-dose MVA-BN vaccine series. Participants were excluded if they were pregnant, acutely ill, involved in another research study or had vaccine administration in the past 28 days, or had conditions that could have put the participant at an unacceptable risk. 1000 (62·5%) participants were administered the liquid formulation and 600 (37·5%) participants were administered the reconstituted lyophilised formulation. Vaccine doses were given on study days 0 and 28 and participants followed up at specified timepoints for up to 2 years for serological monitoring (14, 28, 42, 180, 365, 545, and 730 days). Participants were evaluated for immediate vaccine reactions, given adverse event diaries to document specific adverse events for 7 days following vaccine administration, and asked about potential adverse events at later timepoints up to the 2-year mark. The primary outcome was to assess the safety of MVA-BN for up to 2 years across formulations in a population at increased risk of mpox. This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> (<span><span>NCT02977715</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>).<h3>Findings</h3>There was no significant difference in the risk of an adverse event between the liquid formulation (488 [49·0%] of 995 participants) and lyophilised formulation (315 [53·7%] of 586 participants; adjusted risk ratio [aRR] 1·08 [95% CI 0·98–1·19]) within 7 days after vaccination. Within 7 days of vaccine administration, participants had similar proportions of local injection-site reactions between the liquid (356 [35·7%] of 995 participants) and lyophilised (213 [36·3%] of 586 participants) formulations, but those who received the lyophilised formulation had a higher risk for systemic symptoms than those who received the liquid formulation (aRR 1·20 [95% CI 1·05–1·37]). 18 serious adverse events, including 17 deaths and one stillbirth, oc
安卡拉-巴伐利亚北欧改良痘苗(MVA-BN)是第三代复制缺陷型天花和m痘疫苗,采用液体和冻干制剂制备。刚果民主共和国每年报告的麻疹病例数量最多。高收入国家可获得MVA-BN的安全性数据,但非洲大陆对MVA-BN的全面安全性评估有限。方法2017年2月23日至8月29日和2019年8月15日至9月17日,在Tshuapa省和金沙萨有m痘风险的1600名成人(18岁及以上)卫生保健人员(如医生、护士和技术人员)参加了一项前瞻性队列研究,以评估两剂MVA-BN系列疫苗的安全性。如果参与者怀孕、患有急性疾病、参与另一项研究或在过去28天内接种过疫苗,或有可能使参与者处于不可接受风险的情况,则排除在外。1000名(62.5%)参与者服用液体制剂,600名(37.5%)参与者服用重组冻干制剂。在研究第0天和第28天给予疫苗剂量,参与者在指定时间点随访长达2年,进行血清学监测(14、28、42、180、365、545和730天)。评估参与者的即时疫苗反应,给予不良事件日记以记录疫苗接种后7天的特定不良事件,并询问在2年后的时间点潜在的不良事件。主要结果是评估MVA-BN在m痘风险增加人群中长达2年的安全性。该研究已在ClinicalTrials.gov注册(NCT02977715)。结果:液体制剂(995名参与者中的488名[49.0%])和冻干制剂(586名参与者中的315名[53.7%])在接种后7天内发生不良事件的风险无显著差异;调整风险比[aRR] 1.08 [95% CI 0.98 - 1.19])。在接种疫苗的7天内,参与者在液体制剂(995名参与者中有356名[35.7%])和冻干制剂(586名参与者中有213名[36.3%])之间的局部注射部位反应比例相似,但接受冻干制剂的患者出现全身症状的风险高于接受液体制剂的患者(aRR为1.20 [95% CI为1.05 - 1.37])。在2年的研究期间发生了18起严重不良事件,包括17例死亡和1例死产;安全监察员(两名委员会认证的医生:一名在美国,一名在刚果民主共和国)认为这些事件与疫苗接种没有因果关系。14人在接种疫苗后1个月内怀孕,13人生下健康婴儿。本研究增加了越来越多关于MVA-BN在不同人群中的安全性的文献。尽管受到特定不良事件分级不完整、孕妇人数少以及医疗保健可及性和基础设施差异的限制,来自刚果民主共和国这一队列的数据确实显示了液体和冻干疫苗制剂长达2年的良好安全性结果。由于MVA-BN疫苗接种运动对I和II支支m痘暴发反应至关重要,因此本研究支持MVA-BN在该人群中的安全性的数据是建立疫苗信心的关键。美国疾病控制与预防中心和美国生物医学高级研究与发展管理局。摘要的法文译本见补充资料部分。
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引用次数: 0
Correction to Lancet Infect Dis 2026; published online Jan 28. https://doi.org/10.1016/S1473-3099(25)00747-9 《柳叶刀传染病2026》修订版;1月28日在线发布。https://doi.org/10.1016/s1473 - 3099 (25) 00747 - 9
IF 56.3 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2026-03-02 DOI: 10.1016/s1473-3099(26)00120-9
{"title":"Correction to Lancet Infect Dis 2026; published online Jan 28. https://doi.org/10.1016/S1473-3099(25)00747-9","authors":"","doi":"10.1016/s1473-3099(26)00120-9","DOIUrl":"https://doi.org/10.1016/s1473-3099(26)00120-9","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"31 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2026-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147360569","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
Methodological considerations in the attribution of long COVID to first or second infection - Authors' reply. 将长冠状病毒归为首次或第二次感染的方法学考虑——作者回复。
IF 31 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2026-03-01 Epub Date: 2026-01-08 DOI: 10.1016/S1473-3099(25)00776-5
Bingyu Zhang, Qiong Wu, Ravi Jhaveri, Christopher B Forrest, Yong Chen
{"title":"Methodological considerations in the attribution of long COVID to first or second infection - Authors' reply.","authors":"Bingyu Zhang, Qiong Wu, Ravi Jhaveri, Christopher B Forrest, Yong Chen","doi":"10.1016/S1473-3099(25)00776-5","DOIUrl":"10.1016/S1473-3099(25)00776-5","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"e141"},"PeriodicalIF":31.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145953259","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
Precision diagnostics for MBLs: the true game changer in treating antimicrobial resistance - Authors' reply. MBLs的精确诊断:治疗抗菌素耐药性的真正游戏规则改变者——作者的答复。
IF 31 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2026-03-01 DOI: 10.1016/S1473-3099(26)00009-5
David L Paterson, Abdullah T Aslan, Patrick N A Harris
{"title":"Precision diagnostics for MBLs: the true game changer in treating antimicrobial resistance - Authors' reply.","authors":"David L Paterson, Abdullah T Aslan, Patrick N A Harris","doi":"10.1016/S1473-3099(26)00009-5","DOIUrl":"https://doi.org/10.1016/S1473-3099(26)00009-5","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"26 3","pages":"e145"},"PeriodicalIF":31.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147318915","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
Precision diagnostics for MBLs: the true game changer in treating antimicrobial resistance. MBLs的精确诊断:治疗抗菌素耐药性的真正改变者。
IF 31 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2026-03-01 DOI: 10.1016/S1473-3099(26)00008-3
Brenda A Warecki, María F Mojica, Alejandro J Vila, Robert A Bonomo
{"title":"Precision diagnostics for MBLs: the true game changer in treating antimicrobial resistance.","authors":"Brenda A Warecki, María F Mojica, Alejandro J Vila, Robert A Bonomo","doi":"10.1016/S1473-3099(26)00008-3","DOIUrl":"https://doi.org/10.1016/S1473-3099(26)00008-3","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"26 3","pages":"e144"},"PeriodicalIF":31.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147318841","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
Peer review at The Lancet Infectious Diseases in 2025. 2025年《柳叶刀传染病》的同行评议。
IF 31 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2026-03-01 DOI: 10.1016/S1473-3099(26)00079-4
Ursula Hofer
{"title":"Peer review at The Lancet Infectious Diseases in 2025.","authors":"Ursula Hofer","doi":"10.1016/S1473-3099(26)00079-4","DOIUrl":"https://doi.org/10.1016/S1473-3099(26)00079-4","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"26 3","pages":"223"},"PeriodicalIF":31.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147318843","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
期刊
Lancet Infectious Diseases
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