Lancet Global Health最新文献

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Top ten research priorities in global burns care: findings from the James Lind Alliance Global Burns Research Priority Setting Partnership. 全球烧伤护理的十大研究重点:来自詹姆斯·林德联盟全球烧伤研究重点设定伙伴关系的研究结果。
IF 34.3 1区 医学
Lancet Global Health Pub Date : 2025-04-23 DOI: 10.1016/s2214-109x(25)00059-2
Hollie Sarah Richards,Robert M T Staruch,Suzannah Kinsella,Jelena Savovic,Riaz Qureshi,Daisy Elliott,Leila Rooshenas,Anni King,Amy Acton,Jonathan Bayuo,Simon Booth,Shobha Chamania,Le Quoc Chieu,Charlotte Coates,Declan Collins,Lise Deguire,Baljit Dheansa,Roy Dudley-Southern,Ian Easton,Dale Edgar,Janine Evans,Sian Falder,Emilio Gonzalez,Alex Holley,Catrina Holley,Ivette L Icaza,Claire Jowett,Jane Leaver,Alice Lee,Niall Martin,Jill Meirte,Nguyen Nh Lam,Catrin Pugh,Mamta Shah,Krissie Stiles,Marielle Vehmeijer,Tanveer Ahmed,Nikki Allorto,Murat Ali Cinar,Lewis Allen Dingle,Orlando Flores,Vincent Gabriel,Dhruv Ghosh,Jotham Gondwe,Teruichi Harada,Jagnoor Jagnoor,Vikash Ranjan Keshri,Goaxing Luo,Andrea Mc Kittrick,Natalie Meyers,Pinki Pargal,Carisa Parrish,Marie-Claude Pelchat,Mohsen Rezaeian,Edrisa Sanyang,Atul Suroy,Khaled Taibi,Leila Ait Abderrahim,Luiz Philipe Molina Vana,Katie Wang,Nukhba Zia,Jane M Blazeby,Amber Young
{"title":"Top ten research priorities in global burns care: findings from the James Lind Alliance Global Burns Research Priority Setting Partnership.","authors":"Hollie Sarah Richards,Robert M T Staruch,Suzannah Kinsella,Jelena Savovic,Riaz Qureshi,Daisy Elliott,Leila Rooshenas,Anni King,Amy Acton,Jonathan Bayuo,Simon Booth,Shobha Chamania,Le Quoc Chieu,Charlotte Coates,Declan Collins,Lise Deguire,Baljit Dheansa,Roy Dudley-Southern,Ian Easton,Dale Edgar,Janine Evans,Sian Falder,Emilio Gonzalez,Alex Holley,Catrina Holley,Ivette L Icaza,Claire Jowett,Jane Leaver,Alice Lee,Niall Martin,Jill Meirte,Nguyen Nh Lam,Catrin Pugh,Mamta Shah,Krissie Stiles,Marielle Vehmeijer,Tanveer Ahmed,Nikki Allorto,Murat Ali Cinar,Lewis Allen Dingle,Orlando Flores,Vincent Gabriel,Dhruv Ghosh,Jotham Gondwe,Teruichi Harada,Jagnoor Jagnoor,Vikash Ranjan Keshri,Goaxing Luo,Andrea Mc Kittrick,Natalie Meyers,Pinki Pargal,Carisa Parrish,Marie-Claude Pelchat,Mohsen Rezaeian,Edrisa Sanyang,Atul Suroy,Khaled Taibi,Leila Ait Abderrahim,Luiz Philipe Molina Vana,Katie Wang,Nukhba Zia,Jane M Blazeby,Amber Young","doi":"10.1016/s2214-109x(25)00059-2","DOIUrl":"https://doi.org/10.1016/s2214-109x(25)00059-2","url":null,"abstract":"Burns are a global issue that can result in lifelong multimorbidities and disproportionately affect people in low-resource settings. Prioritising research of importance to patients and health-care professionals improves evidence-based care. This prioritisation setting partnership was undertaken in global burn care (focusing on thermal non-electrical burns) by establishing a James Lind Alliance research priority setting partnership. Over 2 years, two online multilingual surveys with patients, carers, and clinicians, 16 interviews, and a virtual priority setting workshop were conducted to identify and prioritise questions for research. Survey responses were received from participants in 88 countries (1617 survey one respondents; 630 survey two respondents). A short-list of 19 research priorities were ranked at an online workshop attended by 28 participants (14 health-care professionals, ten burn survivors, and four carers or advocates) from 15 countries to produce the final top ten research priorities. These priorities provide opportunities for researchers, funders, and clinicians to shape the future of burns research and improve burns care globally.","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"47 1","pages":""},"PeriodicalIF":34.3,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143885463","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
Correction to Lancet Glob Health 2025; published online April 22. https://doi.org/10.1016/S2214-109X(25)00054-3. 《柳叶刀全球健康2025》更正;4月22日在网上发表。https://doi.org/10.1016/s2214 - 109 x(25) 00054 - 3。
IF 19.9 1区 医学
Lancet Global Health Pub Date : 2025-04-23 DOI: 10.1016/S2214-109X(25)00177-9
{"title":"Correction to Lancet Glob Health 2025; published online April 22. https://doi.org/10.1016/S2214-109X(25)00054-3.","authors":"","doi":"10.1016/S2214-109X(25)00177-9","DOIUrl":"10.1016/S2214-109X(25)00177-9","url":null,"abstract":"","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":" ","pages":""},"PeriodicalIF":19.9,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144052908","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
Correction to Lancet Glob Health 2025; published online April 22. https://doi.org/10.1016/S2214-109X(25)00055-5. 《柳叶刀全球健康2025》更正;4月22日在网上发表。https://doi.org/10.1016/s2214 - 109 x(25) 00055 - 5。
IF 19.9 1区 医学
Lancet Global Health Pub Date : 2025-04-23 DOI: 10.1016/S2214-109X(25)00176-7
{"title":"Correction to Lancet Glob Health 2025; published online April 22. https://doi.org/10.1016/S2214-109X(25)00055-5.","authors":"","doi":"10.1016/S2214-109X(25)00176-7","DOIUrl":"10.1016/S2214-109X(25)00176-7","url":null,"abstract":"","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":" ","pages":""},"PeriodicalIF":19.9,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144002340","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
Characterisation of febrile non-traumatic coma in sub-Saharan Africa. 撒哈拉以南非洲地区发热性非创伤性昏迷的特征。
IF 34.3 1区 医学
Lancet Global Health Pub Date : 2025-04-22 DOI: 10.1016/s2214-109x(25)00122-6
Symon M Kariuki,Charles R Newton
{"title":"Characterisation of febrile non-traumatic coma in sub-Saharan Africa.","authors":"Symon M Kariuki,Charles R Newton","doi":"10.1016/s2214-109x(25)00122-6","DOIUrl":"https://doi.org/10.1016/s2214-109x(25)00122-6","url":null,"abstract":"","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"18 1","pages":""},"PeriodicalIF":34.3,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143884991","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
Aetiologies, neuroradiological features, and risk factors for mortality and long-term neurosequelae of febrile coma in Malawian children: a prospective cohort study 马拉维儿童发热性昏迷的病因学、神经放射学特征和死亡率及长期神经后遗症的危险因素:一项前瞻性队列研究
IF 34.3 1区 医学
Lancet Global Health Pub Date : 2025-04-22 DOI: 10.1016/s2214-109x(25)00054-3
Stephen T J Ray PhD, Charlotte E Fuller MRCPCH, Ajisa Ahmadu BSc, Edith Kafoteka BSc, Alice Muiruri-Liomba MPH, Albert Malenga BScPH, Andrew Tebulo DCM, Paul Pensulo BScPCH, Monfort B Gushu BScPH, Cowles Chilingulo BSc, Reena Dwivedi MSc, Karen Chetcuti MSc, Charalampos Attipa PhD, Rachel Byrne PhD, Maryke Nielsen MSc, Jon Rigby PhD, Elisabeth Stockdale MRCPCH, Alex Boubour MSc, Marc Y R Henrion PhD, Josephine Langton MBChB, Catherine Anscombe PhD, Janet Flatley PhD, Tessa Prince PhD, Shivram Avula PhD, Prof Gretchen L Birbeck MD, Douglas G Postels MD, Nicole O'Brien MD, Jennifer Cornick PhD, Prof Benedict D Michael PhD, Prof Tom Solomon FMedSci, Prof Melissa Gladstone PhD, Prof Stephen B Gordon MD, Yamikani Chimalizeni FCPaed, Prof Terrie Taylor DO, Christopher A Moxon PhD, Prof David G Lalloo PhD, Prof Karl Seydel MD PhD, Prof Michael J Griffiths DPhil
{"title":"Aetiologies, neuroradiological features, and risk factors for mortality and long-term neurosequelae of febrile coma in Malawian children: a prospective cohort study","authors":"Stephen T J Ray PhD, Charlotte E Fuller MRCPCH, Ajisa Ahmadu BSc, Edith Kafoteka BSc, Alice Muiruri-Liomba MPH, Albert Malenga BScPH, Andrew Tebulo DCM, Paul Pensulo BScPCH, Monfort B Gushu BScPH, Cowles Chilingulo BSc, Reena Dwivedi MSc, Karen Chetcuti MSc, Charalampos Attipa PhD, Rachel Byrne PhD, Maryke Nielsen MSc, Jon Rigby PhD, Elisabeth Stockdale MRCPCH, Alex Boubour MSc, Marc Y R Henrion PhD, Josephine Langton MBChB, Catherine Anscombe PhD, Janet Flatley PhD, Tessa Prince PhD, Shivram Avula PhD, Prof Gretchen L Birbeck MD, Douglas G Postels MD, Nicole O'Brien MD, Jennifer Cornick PhD, Prof Benedict D Michael PhD, Prof Tom Solomon FMedSci, Prof Melissa Gladstone PhD, Prof Stephen B Gordon MD, Yamikani Chimalizeni FCPaed, Prof Terrie Taylor DO, Christopher A Moxon PhD, Prof David G Lalloo PhD, Prof Karl Seydel MD PhD, Prof Michael J Griffiths DPhil","doi":"10.1016/s2214-109x(25)00054-3","DOIUrl":"https://doi.org/10.1016/s2214-109x(25)00054-3","url":null,"abstract":"Children in febrile coma in Africa are frequently hospitalised, with poorer outcomes than those in high-income settings. Cerebral malaria is historically the most common cause of febrile coma. Due to limited diagnostic and radiological resources and a decrease in malaria prevalence, there might be under-recognition of non-malarial coma. However, prospective data are scarce. We aimed to determine causes, neuroradiological features, risk factors for mortality, and neurosequelae of children in febrile coma in Malawi.","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"80 1","pages":""},"PeriodicalIF":34.3,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143880535","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
The aetiologies, mortality, and disability of non-traumatic coma in African children: a systematic review and meta-analysis 非洲儿童非创伤性昏迷的病因、死亡率和致残性:一项系统回顾和荟萃分析
IF 34.3 1区 医学
Lancet Global Health Pub Date : 2025-04-22 DOI: 10.1016/s2214-109x(25)00055-5
Stephen T J Ray PhD, Charlotte E Fuller MRCPCH, Alex Boubour MSc, Taty Tshimangani MD, Edith Kafoteka BSc, Alice Muiruri-Liomba MPH, Albert Malenga BScPH, Andrew Tebulo DCM, Paul Pensulo BScPCH, Monfort B Gushu PScPH, Maryke Nielsen MSc, Madiha Raees MD, Elisabeth Stockdale MRCPCH, Josephine Langton MBChB, Prof Gretchen L Birbeck MD, Naomi Waithira MSc, Laura J Bonnett PhD, Marc YR Henrion PhD, Ericka L Fink MD, Douglas G Postels MD, Nicole O'Brien MD, Anne-Laure Page PhD, Emmanuel Baron MD, Prof Stephen B Gordon MD, Prof Elizabeth Molyneux FRCPCH, Prof Arjen Dondorp PhD, Elizabeth C George PhD, Prof Kathryn Maitland FMedSci, Prof Benedict D Michael PhD, Prof Tom Solomon FMedSci, Yamikani Chimalizeni FCPaed, Prof David G Lalloo PhD, Christopher A Moxon PhD, Prof Terrie Taylor DO, Macpherson Mallewa PhD, Richard Idro PhD, Prof Karl Seydel MD PhD, Prof Michael J Griffiths DPhil
{"title":"The aetiologies, mortality, and disability of non-traumatic coma in African children: a systematic review and meta-analysis","authors":"Stephen T J Ray PhD, Charlotte E Fuller MRCPCH, Alex Boubour MSc, Taty Tshimangani MD, Edith Kafoteka BSc, Alice Muiruri-Liomba MPH, Albert Malenga BScPH, Andrew Tebulo DCM, Paul Pensulo BScPCH, Monfort B Gushu PScPH, Maryke Nielsen MSc, Madiha Raees MD, Elisabeth Stockdale MRCPCH, Josephine Langton MBChB, Prof Gretchen L Birbeck MD, Naomi Waithira MSc, Laura J Bonnett PhD, Marc YR Henrion PhD, Ericka L Fink MD, Douglas G Postels MD, Nicole O'Brien MD, Anne-Laure Page PhD, Emmanuel Baron MD, Prof Stephen B Gordon MD, Prof Elizabeth Molyneux FRCPCH, Prof Arjen Dondorp PhD, Elizabeth C George PhD, Prof Kathryn Maitland FMedSci, Prof Benedict D Michael PhD, Prof Tom Solomon FMedSci, Yamikani Chimalizeni FCPaed, Prof David G Lalloo PhD, Christopher A Moxon PhD, Prof Terrie Taylor DO, Macpherson Mallewa PhD, Richard Idro PhD, Prof Karl Seydel MD PhD, Prof Michael J Griffiths DPhil","doi":"10.1016/s2214-109x(25)00055-5","DOIUrl":"https://doi.org/10.1016/s2214-109x(25)00055-5","url":null,"abstract":"Non-traumatic coma in African children is a common life-threatening presentation often leading to hospital attendance. We aimed to estimate the distribution of non-traumatic coma causes and outcomes, including disease-specific outcomes, for which evidence is scarce.","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"7 1","pages":""},"PeriodicalIF":34.3,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143880534","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
The validity of test-negative design for assessment of typhoid conjugate vaccine protection: comparison of estimates by different study designs using data from a cluster-randomised controlled trial. 评估伤寒结合疫苗保护的阴性试验设计的有效性:使用聚类随机对照试验数据的不同研究设计估计值的比较
IF 34.3 1区 医学
Lancet Global Health Pub Date : 2025-04-16 DOI: 10.1016/s2214-109x(25)00056-7
Shuo Feng,Yiyuan Zhang,Farhana Khanam,Merryn Voysey,Virginia E Pitzer,Firdausi Qadri,John D Clemens,Andrew J Pollard,Xinxue Liu
{"title":"The validity of test-negative design for assessment of typhoid conjugate vaccine protection: comparison of estimates by different study designs using data from a cluster-randomised controlled trial.","authors":"Shuo Feng,Yiyuan Zhang,Farhana Khanam,Merryn Voysey,Virginia E Pitzer,Firdausi Qadri,John D Clemens,Andrew J Pollard,Xinxue Liu","doi":"10.1016/s2214-109x(25)00056-7","DOIUrl":"https://doi.org/10.1016/s2214-109x(25)00056-7","url":null,"abstract":"BACKGROUNDTyphoid fever remains a substantial public health challenge in low-income and middle-income countries. By 2023, typhoid conjugate vaccines (TCVs) had been introduced in six countries globally, with more than 50 million doses distributed. Now that TCVs are being deployed, there is a need for observational studies to assess vaccine effectiveness in the field. We aimed to evaluate the validity of different observational study designs in estimating vaccine protection.METHODSWe compared different observational and experimental study designs for assessing vaccine effectiveness by re-analysing data from the TyVAC Bangladesh trial, a participant-blinded and observer-blinded cluster-randomised controlled trial done in Mirpur, Dhaka, Bangladesh. 150 geographical clusters were randomly assigned (1:1) to receive either TCV or Japanese encephalitis vaccine. Eligible children aged 9 months to 15 years were offered a single dose of the vaccine randomly assigned to their cluster of residence, and baseline vaccination was done between April 15 and May 15, 2018. We compared estimates of vaccine effectiveness from the cluster-randomised controlled trial analysis-which assessed the risk of blood-culture-confirmed typhoid fever among recipients of TCV versus recipients of Japanese encephalitis vaccine-with estimates from cohort study and test-negative case-control study design (TND) analyses, which compared recipients of TCV with non-vaccinees in the 75 geographical clusters where TCV was administered. We further conducted negative-control exposure (NCE) and negative-control outcome (NCO) analyses as bias indicators.FINDINGS41 344 (67%) of 62 025 age-eligible children in the study area received the TCV or Japanese encephalitis vaccine during the baseline vaccination campaign. Among the 62 025 age-eligible children, 5582 blood-culture specimens were collected by passive surveillance, including 2546 (46%) specimens from the 75 TCV clusters. The estimated vaccine efficacy was 89% (95% CI 81-93) in the cluster-randomised controlled trial analysis, 79% (70-86) by the cohort design, 88% (79-93) by the TND when pan-negatives were used as test-negative controls, and 90% (75-96) by the TND when specimens positive for pathogens other than Salmonella enterica serotype Typhi were used as test-negative controls. Using NCE analysis, Japanese encephalitis vaccination was associated with an increased risk of typhoid fever compared with non-vaccinees in the 75 Japanese encephalitis clusters in the cohort design (incidence rate ratio 1·98 [95% CI 1·56-2·52]), but no significant association between Japanese encephalitis vaccination and typhoid fever was found with the TND. Similarly, an increased risk of non-typhoid infections was observed in the cohort NCO analyses when comparing vaccinees with non-vaccinees in both Japanese encephalitis vaccine clusters and TCV clusters, but not in the TND NCO analyses.INTERPRETATIONOur findings suggests that the TND provides reliable estim","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"1 1","pages":""},"PeriodicalIF":34.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143853074","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
Diagnostic dilemmas and strain diversity in the MTBVAC phase 1b-2a trial in adults. 成人MTBVAC 1b-2a期试验的诊断困境和菌株多样性。
IF 34.3 1区 医学
Lancet Global Health Pub Date : 2025-04-15 DOI: 10.1016/s2214-109x(25)00066-x
Yanhua Liu,Wenping Gong
{"title":"Diagnostic dilemmas and strain diversity in the MTBVAC phase 1b-2a trial in adults.","authors":"Yanhua Liu,Wenping Gong","doi":"10.1016/s2214-109x(25)00066-x","DOIUrl":"https://doi.org/10.1016/s2214-109x(25)00066-x","url":null,"abstract":"","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"10 1","pages":""},"PeriodicalIF":34.3,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143851076","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
Addressing violence against women with disabilities: shift to action. 解决暴力侵害残疾妇女问题:转向行动。
IF 34.3 1区 医学
Lancet Global Health Pub Date : 2025-04-15 DOI: 10.1016/s2214-109x(25)00118-4
Jane Ndungu
{"title":"Addressing violence against women with disabilities: shift to action.","authors":"Jane Ndungu","doi":"10.1016/s2214-109x(25)00118-4","DOIUrl":"https://doi.org/10.1016/s2214-109x(25)00118-4","url":null,"abstract":"","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"28 1","pages":""},"PeriodicalIF":34.3,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143851037","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
Live-attenuated Mycobacterium tuberculosis vaccine, MTBVAC, in adults with or without M tuberculosis sensitisation: a single-centre, phase 1b-2a, double-blind, dose-escalation, randomised controlled trial. 有或没有结核分枝杆菌致敏的成人减毒结核分枝杆菌活疫苗(MTBVAC):一项单中心、1b-2a期、双盲、剂量递增、随机对照试验
IF 34.3 1区 医学
Lancet Global Health Pub Date : 2025-04-15 DOI: 10.1016/s2214-109x(25)00046-4
Angelique Kany Kany Luabeya,Virginie Rozot,Claire Imbratta,Frances Ratangee,Justin Shenje,Michele Tameris,Simon C Mendelsohn,Hennie Geldenhuys,Michelle Fisher,Munyaradzi Musvosvi,Carly Young,Humphrey Mulenga,Nicole Bilek,Simbarashe Mabwe,Ingrid Murillo Jelsbak,Esteban Rodríguez,Eugenia Puentes,Juana Doce,Nacho Aguilo,Carlos Martin,Cadwill Pillay,Dereck Tait,Marisa Russell,Arrie Van Der Merve,Kathryn Rutkowski,Devin Hunt,Ann Ginsberg,Thomas J Scriba,Mark Hatherill,
{"title":"Live-attenuated Mycobacterium tuberculosis vaccine, MTBVAC, in adults with or without M tuberculosis sensitisation: a single-centre, phase 1b-2a, double-blind, dose-escalation, randomised controlled trial.","authors":"Angelique Kany Kany Luabeya,Virginie Rozot,Claire Imbratta,Frances Ratangee,Justin Shenje,Michele Tameris,Simon C Mendelsohn,Hennie Geldenhuys,Michelle Fisher,Munyaradzi Musvosvi,Carly Young,Humphrey Mulenga,Nicole Bilek,Simbarashe Mabwe,Ingrid Murillo Jelsbak,Esteban Rodríguez,Eugenia Puentes,Juana Doce,Nacho Aguilo,Carlos Martin,Cadwill Pillay,Dereck Tait,Marisa Russell,Arrie Van Der Merve,Kathryn Rutkowski,Devin Hunt,Ann Ginsberg,Thomas J Scriba,Mark Hatherill,","doi":"10.1016/s2214-109x(25)00046-4","DOIUrl":"https://doi.org/10.1016/s2214-109x(25)00046-4","url":null,"abstract":"BACKGROUNDAn effective adult vaccine is needed to control tuberculosis. We evaluated the safety and immunogenicity of a live-attenuated Mycobacterium tuberculosis vaccine (MTBVAC).METHODSThis single-centre, phase 1b-2a, double-blind, dose-escalation, randomised controlled trial (NCT02933281) enrolled South African adults previously vaccinated with BCG, who were HIV negative and aged 18-50 years, with or without M tuberculosis sensitisation assessed by QuantiFERON-tuberculosis Gold-Plus assay (QFT). Participants were recruited from the local community and randomly allocated (2:1) to receive MTBVAC (5 × 103, 5 × 104, 5 × 105, or 5 × 106 colony-forming unit [CFU] doses) or BCG revaccination (5 × 105 CFU dose). The primary outcomes were the occurrence of systemic solicited adverse events within 7 days and unsolicited adverse events within 28 days after vaccination, the occurrence of solicited and unsolicited injection-site reactions within 84 days after vaccination, and the occurrence of serious adverse events (SAEs) until the end of study, 365 days after vaccination. Data were analysed per modified intention to treat. The trial is now complete and closed.FINDINGSBetween Jan 15, 2019, and Sept 7, 2020, 485 participants provided consent and were screened. 144 participants were enrolled and 143 (99%) were vaccinated. BCG was administrated to 47 (33%) of 143 and MTBVAC to 96 (67%) of 143. 12 participants with QFT-negative results and 12 with QFT-positive results were randomly allocated to receive each dose of MTBVAC and 24 participants with QFT-negative results and 24 with QFT-positive results were randomly allocated to receive BCG revaccination. Injection-site pain, discharge, erythema, and swelling increased with MTBVAC dose level. MTBVAC 5 × 105 CFU recipients reported a similar proportion of related adverse events (23 [96%] of 24) as BCG recipients (45 [96%] of 47). MTBVAC recipients who were QFT positive reported more injection-site reactions (46 [96%] of 48; 95% CI 85·7-99·5) than MTBVAC recipients who were QFT negative (32 [67%] of 48; 51·6-79·6). No vaccine-related SAEs were reported. All doses of MTBVAC were immunogenic; vaccine-induced antigen-specific CD4 T-cell responses peaked 28 days after vaccination. The MTBVAC 5 × 105 and 5 × 106 CFU doses induced T-helper-cell-1 cytokine-expressing CD4 T-cell responses that exceeded BCG-induced responses in participants who were QFT negative and QFT positive.INTERPRETATIONMTBVAC at the 5 × 105 dose showed similar safety and reactogenicity and greater immunogenicity when compared to BCG. These results suggest that the 5 × 105 dose of MTBVAC could be selected for a subsequent efficacy evaluation.FUNDINGCongressionally Directed Medical Research Programmes and US National Institutes of Health.","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"108 1","pages":""},"PeriodicalIF":34.3,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143851075","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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