Pub Date : 2024-11-08DOI: 10.1016/s1473-3099(24)00578-4
Elizabeth D Hermsen, James Amos, Andy Townsend, Thomas Becker, Sally Hargreaves
Refugees and asylum seekers might have an increased risk of antimicrobial resistance (AMR) carriage or infection due to several factors, with conflict and war known to accelerate the spread of AMR. However, data are scarce on prevalence and risk factors for AMR among refugees and asylum seekers and how they are affected globally; in addition, how their risk compares to that of the host-country population is unclear. We aimed to explore and assess global AMR data among refugees and asylum seekers. Ovid (MEDLINE and Embase) and PubMed were searched for peer-reviewed primary research articles from Jan 1, 2015, to Oct 23, 2023, and articles were included if they reported carriage or infection with laboratory-confirmed drug-resistant organisms in refugees or asylum seekers from any country. Of 884 articles identified, 41 reported prevalence of AMR among 16 970 refugees and asylum seekers and were included in the study. The most common phenotypes reported were multidrug-resistant Gram-negative bacteria (n=26; prevalence ranged from 4·2% to 60·8%), methicillin-resistant Staphylococcus aureus (n=24; 0·92% to 73%), and extended-spectrum β-lactamase-producing Gram-negative bacteria (n=20; 1·6% to 61·1%). Refugees and asylum seekers had a higher likelihood of carriage or infection with any AMR than the host-country population (n=7849 vs n=81 283, respectively; odds ratio 2·88, 95% CI 2·61–3·18; I2=94%). Refugees and asylum seekers are at an increased risk of AMR carriage and infection, with our data suggesting that refugees and asylum seekers might be exposed to conditions that support the emergence of drug resistance (including living in overcrowded camps and facing barriers to health and vaccine systems). Hence, more global and regional data on AMR are needed through strengthened surveillance programmes and health-care facilities, especially in low-income and middle-income countries. Increased efforts are needed to drive improvements in infection prevention and control (including vaccination), antimicrobial stewardship, treatment strategies tailored to groups at high risk, accessiblity to quality health care in these populations at risk globally, and address risk factors such as poor living and transit conditions.
由于多种因素，难民和寻求庇护者携带或感染抗菌素耐药性（AMR）的风险可能会增加，众所周知，冲突和战争会加速 AMR 的传播。然而，有关难民和寻求庇护者中AMR的流行情况和风险因素以及他们在全球范围内受到何种影响的数据却很少；此外，他们的风险与东道国人口的风险相比如何也不清楚。我们旨在探索和评估全球难民和寻求庇护者中的AMR数据。我们检索了Ovid（MEDLINE和Embase）和PubMed上从2015年1月1日至2023年10月23日经同行评议的主要研究文章，如果这些文章报道了来自任何国家的难民或寻求庇护者携带或感染实验室确认的耐药菌，则将其纳入研究范围。在确定的884篇文章中，有41篇报道了16 970名难民和寻求庇护者中AMR的流行情况，并被纳入研究。报告中最常见的表型是耐多药革兰氏阴性菌（26人；流行率从4-2%到60-8%不等）、耐甲氧西林金黄色葡萄球菌（24人；0-92%到73%）和产扩展谱β-内酰胺酶革兰氏阴性菌（20人；1-6%到61-1%）。与东道国人口相比，难民和寻求庇护者携带或感染任何AMR的可能性更高（分别为7849人和81 283人；几率比2-88，95% CI 2-61-3-18；I2=94%）。难民和寻求庇护者携带和感染AMR的风险增加，我们的数据表明，难民和寻求庇护者可能会暴露在支持耐药性出现的条件下（包括生活在过度拥挤的难民营，面临卫生和疫苗系统的障碍）。因此，需要通过加强监测计划和医疗保健设施，特别是在低收入和中等收入国家，获得更多有关 AMR 的全球和区域数据。需要加大力度，推动改善感染预防和控制（包括疫苗接种）、抗菌药物管理、针对高危人群的治疗策略、这些全球高危人群获得优质医疗服务的机会，并解决生活和过境条件恶劣等风险因素。
{"title":"Antimicrobial resistance among refugees and asylum seekers: a global systematic review and meta-analysis","authors":"Elizabeth D Hermsen, James Amos, Andy Townsend, Thomas Becker, Sally Hargreaves","doi":"10.1016/s1473-3099(24)00578-4","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00578-4","url":null,"abstract":"Refugees and asylum seekers might have an increased risk of antimicrobial resistance (AMR) carriage or infection due to several factors, with conflict and war known to accelerate the spread of AMR. However, data are scarce on prevalence and risk factors for AMR among refugees and asylum seekers and how they are affected globally; in addition, how their risk compares to that of the host-country population is unclear. We aimed to explore and assess global AMR data among refugees and asylum seekers. Ovid (MEDLINE and Embase) and PubMed were searched for peer-reviewed primary research articles from Jan 1, 2015, to Oct 23, 2023, and articles were included if they reported carriage or infection with laboratory-confirmed drug-resistant organisms in refugees or asylum seekers from any country. Of 884 articles identified, 41 reported prevalence of AMR among 16 970 refugees and asylum seekers and were included in the study. The most common phenotypes reported were multidrug-resistant Gram-negative bacteria (n=26; prevalence ranged from 4·2% to 60·8%), methicillin-resistant <em>Staphylococcus aureus</em> (n=24; 0·92% to 73%), and extended-spectrum β-lactamase-producing Gram-negative bacteria (n=20; 1·6% to 61·1%). Refugees and asylum seekers had a higher likelihood of carriage or infection with any AMR than the host-country population (n=7849 <em>vs</em> n=81 283, respectively; odds ratio 2·88, 95% CI 2·61–3·18; <em>I</em><sup>2</sup>=94%). Refugees and asylum seekers are at an increased risk of AMR carriage and infection, with our data suggesting that refugees and asylum seekers might be exposed to conditions that support the emergence of drug resistance (including living in overcrowded camps and facing barriers to health and vaccine systems). Hence, more global and regional data on AMR are needed through strengthened surveillance programmes and health-care facilities, especially in low-income and middle-income countries. Increased efforts are needed to drive improvements in infection prevention and control (including vaccination), antimicrobial stewardship, treatment strategies tailored to groups at high risk, accessiblity to quality health care in these populations at risk globally, and address risk factors such as poor living and transit conditions.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"1 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142596485","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}
Pub Date : 2024-11-07DOI: 10.1016/s1473-3099(24)00616-9
Ming-Zhu Zhang, Cai Bian, Run-Ze Ye, Xiao-Ming Cui, Nan-Nan Yao, Ji-Hu Yang, Yan-Li Chu, Xiao-Ling Su, Ya-Fei Wu, Jin-Ling Ye, Shun-Shuai Liu, Xiao-Yu Shi, Wenqiang Shi, Na Jia, Yu-Guo Chen, Lin Zhao, Yuan-Chun Zheng, Xiao-Min Zheng, Jia-Fu Jiang, Wu-Chun Cao
Background
Yezo virus (YEZV) is an emerging tick-borne pathogen, which was initially reported in Japan in 2021. Only one patient had been reported in China so far. We aimed to describe the epidemiological, clinical, and laboratory findings of a series of patients, and to characterise the viral genomes of YEZV.
Methods
In this active surveillance and genomic analysis, we conducted active surveillance at Mudanjiang Forestry Central Hospital, Heilongjiang Province of northeast China. Participants were eligible for inclusion if they sought medical care for a recent tick bite between May 1 and July 31, in 2022 and 2023, and between May 1 and July 10, in 2024. We collected sera from participants to detect YEZV infection by meta-transcriptomic sequencing, real-time RT-PCR, and indirect immunofluorescence assay. We isolated YEZV by cell culture and characterised the pathogen by morphological and phylogenetic analyses.
Findings
A series of 18 patients with YEZV infection (12 male and six female; median age 53 years, IQR 45–60) were identified among 988 participants. The patients presented with fever (18 patients, 100%), headache (ten patients, 56%), dizziness (nine patients, 50%), malaise (three patients, 17%), lumbago (three patients, 17%), and cough (three patients, 17%). Nine (50%) patients had rash around the tick bite site and four (22%) had lymphadenopathy. Nine (50%) patients had gastrointestinal symptoms, and five (28%) had neurological symptoms. We observed leukopenia in ten (63%) and thrombocytopenia in five (31%) of 16 assessed patients. Elevated hepatic transaminase concentrations were identified in 13 (72%) of all 18 patients, lactate dehydrogenase or α-hydroxybutyric dehydrogenase in nine (50%), serum amyloid protein A in 13 (72%), and hypersensitive C-reactive protein in ten (56%). Eight (7%) of 119 Ixodes persulcatus ticks removed from participants were positive for YEZV. Three YEZV strains were isolated from the sera of patients. Ten viral genomes were obtained from five patients, a blood-sucking I persulcatus removed from a participant, and four host-questing tick samples collected in the areas where patients were identified or in the adjacent region. Phylogenetic analyses revealed that YEZVs in either patients or ticks were divided into two clades, each with distinct mutations.
Interpretation
Awareness of YEZV infection is important and clinicians should consider the virus when diagnosing patients with suitable symptoms.
Funding
National Key Research and Development Program of China.
Translation
For the Chinese translation of the abstract see Supplementary Materials section.
{"title":"A series of patients infected with the emerging tick-borne Yezo virus in China: an active surveillance and genomic analysis","authors":"Ming-Zhu Zhang, Cai Bian, Run-Ze Ye, Xiao-Ming Cui, Nan-Nan Yao, Ji-Hu Yang, Yan-Li Chu, Xiao-Ling Su, Ya-Fei Wu, Jin-Ling Ye, Shun-Shuai Liu, Xiao-Yu Shi, Wenqiang Shi, Na Jia, Yu-Guo Chen, Lin Zhao, Yuan-Chun Zheng, Xiao-Min Zheng, Jia-Fu Jiang, Wu-Chun Cao","doi":"10.1016/s1473-3099(24)00616-9","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00616-9","url":null,"abstract":"<h3>Background</h3>Yezo virus (YEZV) is an emerging tick-borne pathogen, which was initially reported in Japan in 2021. Only one patient had been reported in China so far. We aimed to describe the epidemiological, clinical, and laboratory findings of a series of patients, and to characterise the viral genomes of YEZV.<h3>Methods</h3>In this active surveillance and genomic analysis, we conducted active surveillance at Mudanjiang Forestry Central Hospital, Heilongjiang Province of northeast China. Participants were eligible for inclusion if they sought medical care for a recent tick bite between May 1 and July 31, in 2022 and 2023, and between May 1 and July 10, in 2024. We collected sera from participants to detect YEZV infection by meta-transcriptomic sequencing, real-time RT-PCR, and indirect immunofluorescence assay. We isolated YEZV by cell culture and characterised the pathogen by morphological and phylogenetic analyses.<h3>Findings</h3>A series of 18 patients with YEZV infection (12 male and six female; median age 53 years, IQR 45–60) were identified among 988 participants. The patients presented with fever (18 patients, 100%), headache (ten patients, 56%), dizziness (nine patients, 50%), malaise (three patients, 17%), lumbago (three patients, 17%), and cough (three patients, 17%). Nine (50%) patients had rash around the tick bite site and four (22%) had lymphadenopathy. Nine (50%) patients had gastrointestinal symptoms, and five (28%) had neurological symptoms. We observed leukopenia in ten (63%) and thrombocytopenia in five (31%) of 16 assessed patients. Elevated hepatic transaminase concentrations were identified in 13 (72%) of all 18 patients, lactate dehydrogenase or α-hydroxybutyric dehydrogenase in nine (50%), serum amyloid protein A in 13 (72%), and hypersensitive C-reactive protein in ten (56%). Eight (7%) of 119 <em>Ixodes persulcatus</em> ticks removed from participants were positive for YEZV. Three YEZV strains were isolated from the sera of patients. Ten viral genomes were obtained from five patients, a blood-sucking <em>I persulcatus</em> removed from a participant, and four host-questing tick samples collected in the areas where patients were identified or in the adjacent region. Phylogenetic analyses revealed that YEZVs in either patients or ticks were divided into two clades, each with distinct mutations.<h3>Interpretation</h3>Awareness of YEZV infection is important and clinicians should consider the virus when diagnosing patients with suitable symptoms.<h3>Funding</h3>National Key Research and Development Program of China.<h3>Translation</h3>For the Chinese translation of the abstract see Supplementary Materials section.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"18 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142596549","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}
Pub Date : 2024-11-07DOI: 10.1016/s1473-3099(24)00656-x
Amanda E Semper, Janie Olver, Jenny Warner, Ana Cehovin, Petra C Fay, Peter J Hart, Josephine P Golding, Virginia Benassi, Marie-Pierre Preziosi, Khdair Hazbar Razzaq Al-Asadi, Lucille H Blumberg, José de la Fuente, Nazif Elaldi, Tom Fletcher, Pierre B H Formenty, Mohammad Mehdi Gouya, Stephan Günther, Roger Hewson, Bushra Jamil, Gary Kobinger, Timothy J G Brooks
Crimean–Congo haemorrhagic fever (CCHF) is a widely distributed and potentially fatal tick-borne viral disease with no licensed specific treatments or vaccines. In 2019, WHO published an advanced draft of a research and development roadmap for CCHF that prioritised the development and deployment of the medical countermeasures most needed by CCHF-affected countries. This Personal View presents updated CCHF research and development priorities and is the product of broad consultation with a working group of 20 leading experts in 2023–24. The strategic goals, milestones, and timelines have been revised and expanded to reflect scientific advances since 2019, including the identification of antibodies with therapeutic potential and the progression of four vaccine candidates through phase 1 clinical trials. This update emphasises the need for a One Health approach to manage CCHF, from integrated cross-sectoral surveillance to novel interventions that target ticks and their vertebrate hosts to reduce CCHF virus transmission to humans. The overarching vision for rapid diagnostics and specific therapeutics by 2028, followed by options to limit CCHF virus transmission and control disease by 2030, is deliberately ambitious and will only be achieved through coordinated international action from affected countries, funders, scientists, product developers, manufacturers, regulators, national authorities, and policy makers.
{"title":"Research and product development for Crimean–Congo haemorrhagic fever: priorities for 2024–30","authors":"Amanda E Semper, Janie Olver, Jenny Warner, Ana Cehovin, Petra C Fay, Peter J Hart, Josephine P Golding, Virginia Benassi, Marie-Pierre Preziosi, Khdair Hazbar Razzaq Al-Asadi, Lucille H Blumberg, José de la Fuente, Nazif Elaldi, Tom Fletcher, Pierre B H Formenty, Mohammad Mehdi Gouya, Stephan Günther, Roger Hewson, Bushra Jamil, Gary Kobinger, Timothy J G Brooks","doi":"10.1016/s1473-3099(24)00656-x","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00656-x","url":null,"abstract":"Crimean–Congo haemorrhagic fever (CCHF) is a widely distributed and potentially fatal tick-borne viral disease with no licensed specific treatments or vaccines. In 2019, WHO published an advanced draft of a research and development roadmap for CCHF that prioritised the development and deployment of the medical countermeasures most needed by CCHF-affected countries. This Personal View presents updated CCHF research and development priorities and is the product of broad consultation with a working group of 20 leading experts in 2023–24. The strategic goals, milestones, and timelines have been revised and expanded to reflect scientific advances since 2019, including the identification of antibodies with therapeutic potential and the progression of four vaccine candidates through phase 1 clinical trials. This update emphasises the need for a One Health approach to manage CCHF, from integrated cross-sectoral surveillance to novel interventions that target ticks and their vertebrate hosts to reduce CCHF virus transmission to humans. The overarching vision for rapid diagnostics and specific therapeutics by 2028, followed by options to limit CCHF virus transmission and control disease by 2030, is deliberately ambitious and will only be achieved through coordinated international action from affected countries, funders, scientists, product developers, manufacturers, regulators, national authorities, and policy makers.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"33 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142596486","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}
Pub Date : 2024-11-07DOI: 10.1016/s1473-3099(24)00688-1
Prerna Arora, Christine Happle, Amy Kempf, Inga Nehlmeier, Metodi V Stankov, Alexandra Dopfer-Jablonka, Georg M N Behrens, Stefan Pöhlmann, Markus Hoffmann
No Abstract
无摘要
{"title":"Impact of JN.1 booster vaccination on neutralisation of SARS-CoV-2 variants KP.3.1.1 and XEC","authors":"Prerna Arora, Christine Happle, Amy Kempf, Inga Nehlmeier, Metodi V Stankov, Alexandra Dopfer-Jablonka, Georg M N Behrens, Stefan Pöhlmann, Markus Hoffmann","doi":"10.1016/s1473-3099(24)00688-1","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00688-1","url":null,"abstract":"No Abstract","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"13 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142596488","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}
Pub Date : 2024-11-06DOI: 10.1016/s1473-3099(24)00576-0
Prasad S Kulkarni, Anand Kawade, Sunil Kohli, Renuka Munshi, Chetna Maliye, Nithya J Gogtay, Ravish H S, Kiranjit Singh, K Vengadakrishnan, Sandeep Kumar Panigrahi, Jyotiranjan Sahoo, Ashish Bavdekar, B S Garg, Abhishek Raut, Jeffrey P Raj, Unnati Saxena, Vijaya L Chaudhari, Rakesh Patil, Epari Venkatarao, Nitu Kumari, Dhananjay Kapse
<h3>Background</h3>Meningococcal disease remains an important public health problem globally. We assessed the non-inferiority and the lot-to-lot consistency of a pentavalent meningococcal ACYWX conjugate vaccine (NmCV-5; Serum Institute of India, Pune, India) versus a quadrivalent meningococcal ACWY conjugate vaccine (MenACWY-D) in healthy adults.<h3>Methods</h3>In this observer-blind, randomised, active-controlled, phase 2/3 study, healthy adults aged 18–85 years were recruited from nine hospitals across seven cities in India. Participants were grouped by age (age 18–29, 30–60, and 61–85 years), and within each age group they were randomly assigned (3:1) to receive either NmCV-5 or MenACWY-D (Sanofi Pasteur). In the age 18–29 years group, participants were additionally randomly assigned (1:1:1:1) to either lot A, lot B, or lot C of NmCV-5 or MenACWY-D. Block randomisation was used (block sizes of 4, 8, and 12). Study participants and study personnel were masked to treatment assignment. Participants received either a 0·5 mL dose of NmCV-5, containing 5 μg each of conjugated A, C, W, Y, and X polysaccharides, or 0·5 mL MenACWY-D, containing 4 μg of each of conjugated A, C, W, and Y polysaccharides. Vaccinations were administered intramuscularly in the deltoid muscle. The primary outcomes were seroresponse (non-inferiority margin of –10%) and geometric mean titres (GMTs; non-inferiority margin of 0·5) in all participants, and lot-to-lot consistency of NmCV-5 (in participants aged 18–29 years; consistency was shown if the geometric mean ratio [GMR] 95% CIs were within the limit interval of 0·5 to 2). For non-inferiority, serogroup X immune response in the NmCV-5 group was compared with the lowest immune response among serogroups A, C, W, and Y in the MenACWY-D group. Immunogenicity was assessed with a serum bactericidal activity assay that used baby rabbit serum as the complement (rSBA) on days 1 and 29 in the modified per-protocol population (including all participants who were randomly assigned, received vaccine, had a post-vaccination rSBA measurement up to 121 days after vaccination, and no major protocol violations). Solicited events were collected for 7 days and serious adverse events were collected for 180 days, and assessed in the safety population (all participants who received vaccination). 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>NCT04358731</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>, and CTRI, CTRI/2019/12/022436, and is now complete.<h3>Findings</h3>Between Dec 27, 2019, and Sept 19, 2020, 1712 individuals were screened, of whom 1
背景脑膜炎球菌疾病仍然是全球重要的公共卫生问题。我们评估了五价脑膜炎球菌 ACYWX 结合疫苗（NmCV-5；印度普纳血清研究所）与四价脑膜炎球菌 ACWY 结合疫苗（MenACWY-D）在健康成人中的非劣效性和批间一致性。方法在这项观察盲、随机、主动对照的 2/3 期研究中，我们从印度 7 个城市的 9 家医院招募了 18-85 岁的健康成人。参与者按年龄分组（18-29 岁、30-60 岁和 61-85 岁），并在每个年龄组内按 3:1 随机分配接受 NmCV-5 或 MenACWY-D （赛诺菲巴斯德）治疗。在 18-29 岁组中，参与者还被随机分配（1:1:1:1:1）到 NmCV-5 或 MenACWY-D 的 A 批、B 批或 C 批。采用区组随机分配法（区组大小为 4、8 和 12）。研究参与者和研究人员对治疗分配进行了蒙蔽。参与者接种 0-5 mL NmCV-5（含 A、C、W、Y 和 X 共轭多糖各 5 μg）或 0-5 mL MenACWY-D（含 A、C、W 和 Y 共轭多糖各 4 μg）。接种方法为三角肌肌肉注射。主要结果是所有参与者的血清反应（非劣效差为-10%）和几何平均滴度（GMT；非劣效差为0-5），以及NmCV-5的批次间一致性（18-29岁的参与者；如果几何平均比值[GMR] 95% CI在0-5至2的极限区间内，则表示一致性）。对于非劣效性，NmCV-5 组的 X 血清群免疫反应与 MenACWY-D 组的 A、C、W 和 Y 血清群中最低的免疫反应进行了比较。在修改后的按协议接种人群（包括所有随机分配、接种疫苗、接种后 rSBA 测定达 121 天且无重大违反协议行为的参与者）中，使用兔宝宝血清作为补体（rSBA），在第 1 天和第 29 天进行血清杀菌活性测定，评估免疫原性。在安全人群（所有接种疫苗的参与者）中收集 7 天的诱发事件和 180 天的严重不良事件。本研究已在ClinicalTrials.gov（NCT04358731）和CTRI（CTRI/2019/12/022436）注册，现已完成。研究结果在2019年12月27日至2020年9月19日期间，共筛选出1712人，其中1640人被随机分配并接受NmCV-5（n=1233）或MenACWY-D（n=407；平均年龄26-4岁[SD 12-2]，1640人中551人[33-6%]为女性，1089人[66-4%]为男性）。1441名参与者年龄在18-29岁之间（362人接受了A批、360人接受了B批和361人接受了C批NmCV-5，357人接受了MenACWY-D，其中一名参与者因年龄组随机错误而被排除在批间一致性分析之外）。就所有五个血清群的血清反应率和 GMT 比值而言，NmCV-5 与 MenACWY-D 相比无劣效性。NmCV-5组的血清反应率为84-3%（97-5% CI为81-7至86-7；血清群A）或更高，而MenACWY-D组的血清反应率为54-5%（48-5至60-3；血清群A）或更高，疫苗组间的血清反应率差异从血清群W的0-2（97-5% CI为-2-2至2-6）到血清群A的29-8（24-4至35-2）不等。第 29 天，NmCV-5 组的 GMT 为 7016-9 (97-5% CI 6475-7 to 7603-4; Y 血清群) 或更高，MenACWY-D 组的 GMT 为 3646-8 (3188-2 to 4171-5; Y 血清群) 或更高，疫苗组间血清群 A、C、Y 和 W 的 GMT 比值从血清群 W 的 1-9 (97-5% CI 1-5-2-3) 到血清群 A 的 2-5 (2-2-2-8)不等。NmCV-5 可诱导针对血清 X 群的强大免疫反应。在所有五个血清群中，NmCV-5 的批次间一致性被发现，每对批次的 GMT 比值的 95% CI 在 0-5 和 2 之间：在五个血清群中，NmCV-5 的批次 A 和批次 B 之间 GMR 的最低下限和最高上限分别为 0-6 和 1-4，批次 A 和批次 C 之间分别为 0-7 和 1-6，批次 B 和批次 C 之间分别为 0-8 和 1-6。在 NmCV-5 组的 1233 名参与者中，有 527 人（42-7%）报告了至少一种征集到的不良事件；在 MenACWY-D 组的 407 名参与者中，有 142 人（34-9%）报告了至少一种征集到的不良事件。在血清反应和GMT方面，NmCV-5并不劣于MenACWY-D，而且安全，并表现出批次间的一致性。NmCV-5已通过世卫组织的预认证，并于2024年4月在非洲脑膜炎带推出。
{"title":"Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study","authors":"Prasad S Kulkarni, Anand Kawade, Sunil Kohli, Renuka Munshi, Chetna Maliye, Nithya J Gogtay, Ravish H S, Kiranjit Singh, K Vengadakrishnan, Sandeep Kumar Panigrahi, Jyotiranjan Sahoo, Ashish Bavdekar, B S Garg, Abhishek Raut, Jeffrey P Raj, Unnati Saxena, Vijaya L Chaudhari, Rakesh Patil, Epari Venkatarao, Nitu Kumari, Dhananjay Kapse","doi":"10.1016/s1473-3099(24)00576-0","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00576-0","url":null,"abstract":"<h3>Background</h3>Meningococcal disease remains an important public health problem globally. We assessed the non-inferiority and the lot-to-lot consistency of a pentavalent meningococcal ACYWX conjugate vaccine (NmCV-5; Serum Institute of India, Pune, India) versus a quadrivalent meningococcal ACWY conjugate vaccine (MenACWY-D) in healthy adults.<h3>Methods</h3>In this observer-blind, randomised, active-controlled, phase 2/3 study, healthy adults aged 18–85 years were recruited from nine hospitals across seven cities in India. Participants were grouped by age (age 18–29, 30–60, and 61–85 years), and within each age group they were randomly assigned (3:1) to receive either NmCV-5 or MenACWY-D (Sanofi Pasteur). In the age 18–29 years group, participants were additionally randomly assigned (1:1:1:1) to either lot A, lot B, or lot C of NmCV-5 or MenACWY-D. Block randomisation was used (block sizes of 4, 8, and 12). Study participants and study personnel were masked to treatment assignment. Participants received either a 0·5 mL dose of NmCV-5, containing 5 μg each of conjugated A, C, W, Y, and X polysaccharides, or 0·5 mL MenACWY-D, containing 4 μg of each of conjugated A, C, W, and Y polysaccharides. Vaccinations were administered intramuscularly in the deltoid muscle. The primary outcomes were seroresponse (non-inferiority margin of –10%) and geometric mean titres (GMTs; non-inferiority margin of 0·5) in all participants, and lot-to-lot consistency of NmCV-5 (in participants aged 18–29 years; consistency was shown if the geometric mean ratio [GMR] 95% CIs were within the limit interval of 0·5 to 2). For non-inferiority, serogroup X immune response in the NmCV-5 group was compared with the lowest immune response among serogroups A, C, W, and Y in the MenACWY-D group. Immunogenicity was assessed with a serum bactericidal activity assay that used baby rabbit serum as the complement (rSBA) on days 1 and 29 in the modified per-protocol population (including all participants who were randomly assigned, received vaccine, had a post-vaccination rSBA measurement up to 121 days after vaccination, and no major protocol violations). Solicited events were collected for 7 days and serious adverse events were collected for 180 days, and assessed in the safety population (all participants who received vaccination). 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>NCT04358731</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>, and CTRI, CTRI/2019/12/022436, and is now complete.<h3>Findings</h3>Between Dec 27, 2019, and Sept 19, 2020, 1712 individuals were screened, of whom 1","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"140 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594327","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}
Pub Date : 2024-11-06DOI: 10.1016/s1473-3099(24)00743-6
Heil EL, McCreary EK. REVISITing treatment of metallo-β-lactamases. Lancet Infect Dis 2024; published online Oct 7. https://doi.org/10.1016/S1473-3099(24)00561-9—In this Comment, two corrections have been made. The correct treatment difference for clinical cure rate at the test-of-cure visit is 2·7% (95% CI –6·6 to 12·4). The loading dose for aztreonam–avibactam was clarified to state it was how the drug was administered in the REVISIT trial. These corrections have been made to the online version as of Nov 6, 2024, and the printed version will be correct..
Heil EL, McCreary EK.重新审视金属-β-内酰胺酶的治疗。https://doi.org/10.1016/S1473-3099(24)00561-9 在本评论中，有两处更正。治愈试验时临床治愈率的正确治疗差异为 2-7%（95% CI -6-6~12-4）。澄清了阿兹曲南-阿维巴坦的负荷剂量，以说明REVISIT试验中的给药方式。截至 2024 年 11 月 6 日，在线版本已进行了这些更正，印刷版本也将进行更正。
{"title":"Correction to Lancet Infect Dis 2024; published online October 7. https://doi.org/10.1016/S1473-3099(24)00561-9","authors":"","doi":"10.1016/s1473-3099(24)00743-6","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00743-6","url":null,"abstract":"<em>Heil EL, McCreary EK. REVISITing treatment of metallo-</em>β-lactamases. Lancet Infect Dis <em>2024; published online Oct 7. https://doi.org/10.1016/S1473-3099(24)00561-9</em>—In this Comment, two corrections have been made. The correct treatment difference for clinical cure rate at the test-of-cure visit is 2·7% (95% CI –6·6 to 12·4). The loading dose for aztreonam–avibactam was clarified to state it was how the drug was administered in the REVISIT trial. These corrections have been made to the online version as of Nov 6, 2024, and the printed version will be correct..","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"18 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594292","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}
Pub Date : 2024-11-06DOI: 10.1016/s1473-3099(24)00622-4
Michelle Clarke, Helen S Marshall
No Abstract
无摘要
{"title":"A step closer to elimination of meningococcal disease","authors":"Michelle Clarke, Helen S Marshall","doi":"10.1016/s1473-3099(24)00622-4","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00622-4","url":null,"abstract":"No Abstract","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"32 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594293","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}
Pub Date : 2024-11-05DOI: 10.1016/s1473-3099(24)00579-6
Samuel W Mackrill, David C Schramm, Ali Amini, Riina Rautemaa-Richardson, Nicola Jones, Matthew O Brook, Katie Jeffery, Alexander J Mentzer
Disease associated with Cladophialophora bantiana infection is uncommon but can be characterised by severe and life-threatening CNS involvement. Diagnosis is challenging due to both the infection's rarity and non-specific clinical presentation, which can mimic malignancy and infection caused by more common organisms. Transmission can occur via inhalation or inoculation through compromised skin, followed by haematogenous dissemination to the brain and other organs. We report a case of a 42-year-old renal transplant recipient with no travel history presenting with neurological symptoms and skin and lung lesions due to C bantiana infection. An aggressive treatment approach comprising combination antifungal therapy, surgical debridement, and withdrawal of immunosuppression resulted in disease control, although this treatment was complicated by voriconazole-induced skeletal fluorosis. This organism, more commonly encountered in tropical regions, has traditionally been considered imported into the UK by returning travellers, therefore this case of autochthonous infection could reflect an expanding range alongside global climactic shifts.
Cladophialophora bantiana 感染引起的疾病并不常见，但其特征是严重的中枢神经系统受累并危及生命。由于这种感染的罕见性和非特异性临床表现，诊断具有挑战性，因为它可能会模仿恶性肿瘤和由更常见的病原体引起的感染。传播途径可能是吸入或通过受损皮肤接种，然后经血源性传播到大脑和其他器官。我们报告了一例 42 岁的肾移植受者，该患者无旅行史，因感染 C bantiana 而出现神经系统症状以及皮肤和肺部病变。我们采取了积极的治疗方法，包括联合抗真菌治疗、手术清创和停用免疫抑制剂，最终控制了病情，但治疗过程因伏立康唑引起的骨骼氟中毒而变得复杂。这种病菌更常见于热带地区，传统上被认为是由回国旅行者传入英国的，因此这例自体感染病例可能反映出随着全球气候的变化，这种病菌的传播范围也在不断扩大。
{"title":"A case of disseminated autochthonous Cladophialophora bantiana infection in a renal transplant recipient in the UK","authors":"Samuel W Mackrill, David C Schramm, Ali Amini, Riina Rautemaa-Richardson, Nicola Jones, Matthew O Brook, Katie Jeffery, Alexander J Mentzer","doi":"10.1016/s1473-3099(24)00579-6","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00579-6","url":null,"abstract":"Disease associated with <em>Cladophialophora bantiana</em> infection is uncommon but can be characterised by severe and life-threatening CNS involvement. Diagnosis is challenging due to both the infection's rarity and non-specific clinical presentation, which can mimic malignancy and infection caused by more common organisms. Transmission can occur via inhalation or inoculation through compromised skin, followed by haematogenous dissemination to the brain and other organs. We report a case of a 42-year-old renal transplant recipient with no travel history presenting with neurological symptoms and skin and lung lesions due to <em>C bantiana</em> infection. An aggressive treatment approach comprising combination antifungal therapy, surgical debridement, and withdrawal of immunosuppression resulted in disease control, although this treatment was complicated by voriconazole-induced skeletal fluorosis. This organism, more commonly encountered in tropical regions, has traditionally been considered imported into the UK by returning travellers, therefore this case of autochthonous infection could reflect an expanding range alongside global climactic shifts.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"87 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142588331","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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