Pub Date : 2024-08-09DOI: 10.1016/S1473-3099(24)00438-9
Marion P G Koopmans, Casey Barton Behravesh, Andrew A Cunningham, Wiku B Adisasmito, Salama Almuhairi, Pépé Bilivogui, Salome A Bukachi, Natalia Casas, Natalia Cediel Becerra, Dominique F Charron, Abhishek Chaudhary, Janice R Ciacci Zanella, Osman Dar, Nitish Debnath, Baptiste Dungu, Elmoubasher Farag, George F Gao, Margaret Khaitsa, Catherine Machalaba, John S Mackenzie, Wanda Markotter, Thomas C Mettenleiter, Serge Morand, Vyacheslav Smolenskiy, Lei Zhou, David T S Hayman
Changes in the epidemiology and ecology of H5N1 highly pathogenic avian influenza are devastating wild bird and poultry populations, farms and communities, and wild mammals worldwide. Having originated in farmed poultry, H5N1 viruses are now spread globally by wild birds, with transmission to many mammal and avian species, resulting in 2024 in transmission among dairy cattle with associated human cases. These ecological changes pose challenges to mitigating the impacts of H5N1 highly pathogenic avian influenza on wildlife, ecosystems, domestic animals, food security, and humans. H5N1 highly pathogenic avian influenza highlights the need for One Health approaches to pandemic prevention and preparedness, emphasising multisectoral collaborations among animal, environmental, and public health sectors. Action is needed to reduce future pandemic risks by preventing transmission of highly pathogenic avian influenza among domestic and wild animals and people, focusing on upstream drivers of outbreaks, and ensuring rapid responses and risk assessments for zoonotic outbreaks. Political commitment and sustainable funding are crucial to implementing and maintaining prevention programmes, surveillance, and outbreak responses.
{"title":"The panzootic spread of highly pathogenic avian influenza H5N1 sublineage 2.3.4.4b: a critical appraisal of One Health preparedness and prevention.","authors":"Marion P G Koopmans, Casey Barton Behravesh, Andrew A Cunningham, Wiku B Adisasmito, Salama Almuhairi, Pépé Bilivogui, Salome A Bukachi, Natalia Casas, Natalia Cediel Becerra, Dominique F Charron, Abhishek Chaudhary, Janice R Ciacci Zanella, Osman Dar, Nitish Debnath, Baptiste Dungu, Elmoubasher Farag, George F Gao, Margaret Khaitsa, Catherine Machalaba, John S Mackenzie, Wanda Markotter, Thomas C Mettenleiter, Serge Morand, Vyacheslav Smolenskiy, Lei Zhou, David T S Hayman","doi":"10.1016/S1473-3099(24)00438-9","DOIUrl":"https://doi.org/10.1016/S1473-3099(24)00438-9","url":null,"abstract":"<p><p>Changes in the epidemiology and ecology of H5N1 highly pathogenic avian influenza are devastating wild bird and poultry populations, farms and communities, and wild mammals worldwide. Having originated in farmed poultry, H5N1 viruses are now spread globally by wild birds, with transmission to many mammal and avian species, resulting in 2024 in transmission among dairy cattle with associated human cases. These ecological changes pose challenges to mitigating the impacts of H5N1 highly pathogenic avian influenza on wildlife, ecosystems, domestic animals, food security, and humans. H5N1 highly pathogenic avian influenza highlights the need for One Health approaches to pandemic prevention and preparedness, emphasising multisectoral collaborations among animal, environmental, and public health sectors. Action is needed to reduce future pandemic risks by preventing transmission of highly pathogenic avian influenza among domestic and wild animals and people, focusing on upstream drivers of outbreaks, and ensuring rapid responses and risk assessments for zoonotic outbreaks. Political commitment and sustainable funding are crucial to implementing and maintaining prevention programmes, surveillance, and outbreak responses.</p>","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141972154","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 : 2024-08-09DOI: 10.1016/S1473-3099(24)00488-2
Christine Petersen
{"title":"A model of vector-targeted interventions for visceral leishmaniasis.","authors":"Christine Petersen","doi":"10.1016/S1473-3099(24)00488-2","DOIUrl":"https://doi.org/10.1016/S1473-3099(24)00488-2","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141972151","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 : 2024-08-09DOI: 10.1016/S1473-3099(24)00420-1
Luc E Coffeng, Sake J de Vlas, Rudra Pratap Singh, Ananthu James, Joy Bindroo, Niteen K Sharma, Asgar Ali, Chandramani Singh, Sadhana Sharma, Michael Coleman
Background: Efforts to eliminate visceral leishmaniasis in India mainly consist of early detection and treatment of cases and indoor residual spraying with insecticides to kill the phlebotomine sandfly Phlebotomus argentipes that transmits the causative Leishmania protozoa. In this modelling study, we aimed to estimate the effect of indoor residual spraying (IRS) on vector abundance and transmission of visceral leishmaniasis in India.
Methods: In this time-series analysis and modelling study, we assessed the effect of IRS on vector abundance by using indoor vector-abundance data (from 2016 to 2022) and IRS quality-assurance data (from 2017-20) from 50 villages in eight endemic blocks in India where IRS was implemented programmatically. To assess a potential dose-response relation between insecticide concentrations and changes in sandfly abundance, we examined the correlation between site-level insecticide concentrations and the site-level data for monthly sandfly abundances. We used mathematical modelling to link vector data to visceral leishmaniasis case numbers from the national Kala-Azar Management Information System registry (2013-21), and to predict the effect of IRS on numbers of averted cases and deaths.
Findings: IRS was estimated to reduce indoor sandfly abundance by 27% (95% CI 20-34). Concentrations of insecticides on walls were significantly-but weakly-associated with the degree of reduction in vector abundance, with a reduction of -0·0023 (95% CI -0·0040 to -0·0007) sandflies per mg/m2 insecticide (p=0·0057). Reported case numbers of visceral leishmaniasis were well explained by trends in vector abundance. Village-wide IRS in response to a newly detected case of visceral leishmaniasis was predicted to reduce disease incidence by 6-40% depending on the presumed reduction in vector abundance modelled.
Interpretation: Indoor residual spraying has substantially reduced sandfly abundance in India, which has contributed to reductions in visceral leishmaniasis and related deaths. To prevent the re-emergence of visceral leishmaniasis as a public health problem, surveillance of transmission and sandfly abundance is warranted.
Funding: Bill & Melinda Gates Foundation.
Translation: For the Hindi translation of the abstract see Supplementary Materials section.
{"title":"Effect of indoor residual spraying on sandfly abundance and incidence of visceral leishmaniasis in India, 2016-22: an interrupted time-series analysis and modelling study.","authors":"Luc E Coffeng, Sake J de Vlas, Rudra Pratap Singh, Ananthu James, Joy Bindroo, Niteen K Sharma, Asgar Ali, Chandramani Singh, Sadhana Sharma, Michael Coleman","doi":"10.1016/S1473-3099(24)00420-1","DOIUrl":"https://doi.org/10.1016/S1473-3099(24)00420-1","url":null,"abstract":"<p><strong>Background: </strong>Efforts to eliminate visceral leishmaniasis in India mainly consist of early detection and treatment of cases and indoor residual spraying with insecticides to kill the phlebotomine sandfly Phlebotomus argentipes that transmits the causative Leishmania protozoa. In this modelling study, we aimed to estimate the effect of indoor residual spraying (IRS) on vector abundance and transmission of visceral leishmaniasis in India.</p><p><strong>Methods: </strong>In this time-series analysis and modelling study, we assessed the effect of IRS on vector abundance by using indoor vector-abundance data (from 2016 to 2022) and IRS quality-assurance data (from 2017-20) from 50 villages in eight endemic blocks in India where IRS was implemented programmatically. To assess a potential dose-response relation between insecticide concentrations and changes in sandfly abundance, we examined the correlation between site-level insecticide concentrations and the site-level data for monthly sandfly abundances. We used mathematical modelling to link vector data to visceral leishmaniasis case numbers from the national Kala-Azar Management Information System registry (2013-21), and to predict the effect of IRS on numbers of averted cases and deaths.</p><p><strong>Findings: </strong>IRS was estimated to reduce indoor sandfly abundance by 27% (95% CI 20-34). Concentrations of insecticides on walls were significantly-but weakly-associated with the degree of reduction in vector abundance, with a reduction of -0·0023 (95% CI -0·0040 to -0·0007) sandflies per mg/m<sup>2</sup> insecticide (p=0·0057). Reported case numbers of visceral leishmaniasis were well explained by trends in vector abundance. Village-wide IRS in response to a newly detected case of visceral leishmaniasis was predicted to reduce disease incidence by 6-40% depending on the presumed reduction in vector abundance modelled.</p><p><strong>Interpretation: </strong>Indoor residual spraying has substantially reduced sandfly abundance in India, which has contributed to reductions in visceral leishmaniasis and related deaths. To prevent the re-emergence of visceral leishmaniasis as a public health problem, surveillance of transmission and sandfly abundance is warranted.</p><p><strong>Funding: </strong>Bill & Melinda Gates Foundation.</p><p><strong>Translation: </strong>For the Hindi translation of the abstract see Supplementary Materials section.</p>","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141972152","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 : 2024-08-09DOI: 10.1016/S1473-3099(24)00424-9
Paul Kim, Ana M Sanchez, Taylor J R Penke, Hannah H Tuson, James C Kime, Robert W McKee, William L Slone, Nicholas R Conley, Lana J McMillan, Cameron J Prybol, Paul M Garofolo
Background: The rate of antibiotic resistance continues to grow, outpacing small-molecule-drug development efforts. Novel therapies are needed to combat this growing threat, particularly for the treatment of urinary tract infections (UTIs), which are one of the largest contributors to antibiotic use and associated antibiotic resistance. LBP-EC01 is a novel, genetically enhanced, six-bacteriophage cocktail developed by Locus Biosciences (Morrisville, NC, USA) to address UTIs caused by Escherichia coli, regardless of antibiotic resistance status. In this first part of the two-part phase 2 ELIMINATE trial, we aimed to define a dosing regimen of LBP-EC01 for the treatment of uncomplicated UTIs that could advance to the second, randomised, controlled, double-blinded portion of the study.
Methods: This first part of ELIMINATE is a randomised, uncontrolled, open-label, phase 2 trial that took place in six private clinical sites in the USA. Eligible participants were female by self-identification, aged between 18 years and 70 years, and had an uncomplicated UTI at the time of enrolment, as well as a history of at least one drug-resistant UTI caused by E coli within the 12 months before enrolment. Participants were initially randomised in a 1:1:1 ratio into three treatment groups, but this part of the trial was terminated on the recommendation of the safety review committee after a non-serious tolerability signal was observed based on systemic drug exposure. A protocol update was then implemented, comprised of three new treatment groups. Groups A to C were dosed with intraurethral 2 × 1012 plaque-forming units (PFU) of LBP-EC01 on days 1 and 2 by catheter, plus one of three intravenous doses daily on days 1-3 of LBP-EC01 (1 mL of 1 × 1010 PFU intravenous bolus in group A, 1 mL of 1 × 109 PFU intravenous bolus in group B, and a 2 h 1 × 1011 PFU intravenous infusion in 100 mL of sodium lactate solution in group C). In all groups, oral trimethoprim-sulfamethoxazole (TMP-SMX; 160 mg and 800 mg) was given twice daily on days 1-3. The primary outcome was the level of LBP-EC01 in urine and blood across the treatment period and over 48 h after the last dose and was assessed in patients in the intention-to-treat (ITT) population who received at least one dose of LBP-EC01 and had concentration-time data available throughout the days 1-3 dosing period (pharmacokinetic population). Safety, a secondary endpoint, was assessed in enrolled patients who received at least one dose of study drug (safety population). As exploratory pharmacodynamic endpoints, we assessed E coli levels in urine and clinical symptoms of UTI in patients with at least 1·0 × 105 colony-forming units per mL E coli in urine at baseline who took at least one dose of study drug and completed their day 10 test-of-cure assessment (pharmacodynamic-evaluable population). This trial is registered with Clinical
{"title":"Safety, pharmacokinetics, and pharmacodynamics of LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage cocktail, in uncomplicated urinary tract infections due to Escherichia coli (ELIMINATE): the randomised, open-label, first part of a two-part phase 2 trial.","authors":"Paul Kim, Ana M Sanchez, Taylor J R Penke, Hannah H Tuson, James C Kime, Robert W McKee, William L Slone, Nicholas R Conley, Lana J McMillan, Cameron J Prybol, Paul M Garofolo","doi":"10.1016/S1473-3099(24)00424-9","DOIUrl":"https://doi.org/10.1016/S1473-3099(24)00424-9","url":null,"abstract":"<p><strong>Background: </strong>The rate of antibiotic resistance continues to grow, outpacing small-molecule-drug development efforts. Novel therapies are needed to combat this growing threat, particularly for the treatment of urinary tract infections (UTIs), which are one of the largest contributors to antibiotic use and associated antibiotic resistance. LBP-EC01 is a novel, genetically enhanced, six-bacteriophage cocktail developed by Locus Biosciences (Morrisville, NC, USA) to address UTIs caused by Escherichia coli, regardless of antibiotic resistance status. In this first part of the two-part phase 2 ELIMINATE trial, we aimed to define a dosing regimen of LBP-EC01 for the treatment of uncomplicated UTIs that could advance to the second, randomised, controlled, double-blinded portion of the study.</p><p><strong>Methods: </strong>This first part of ELIMINATE is a randomised, uncontrolled, open-label, phase 2 trial that took place in six private clinical sites in the USA. Eligible participants were female by self-identification, aged between 18 years and 70 years, and had an uncomplicated UTI at the time of enrolment, as well as a history of at least one drug-resistant UTI caused by E coli within the 12 months before enrolment. Participants were initially randomised in a 1:1:1 ratio into three treatment groups, but this part of the trial was terminated on the recommendation of the safety review committee after a non-serious tolerability signal was observed based on systemic drug exposure. A protocol update was then implemented, comprised of three new treatment groups. Groups A to C were dosed with intraurethral 2 × 10<sup>12</sup> plaque-forming units (PFU) of LBP-EC01 on days 1 and 2 by catheter, plus one of three intravenous doses daily on days 1-3 of LBP-EC01 (1 mL of 1 × 10<sup>10</sup> PFU intravenous bolus in group A, 1 mL of 1 × 10<sup>9</sup> PFU intravenous bolus in group B, and a 2 h 1 × 10<sup>11</sup> PFU intravenous infusion in 100 mL of sodium lactate solution in group C). In all groups, oral trimethoprim-sulfamethoxazole (TMP-SMX; 160 mg and 800 mg) was given twice daily on days 1-3. The primary outcome was the level of LBP-EC01 in urine and blood across the treatment period and over 48 h after the last dose and was assessed in patients in the intention-to-treat (ITT) population who received at least one dose of LBP-EC01 and had concentration-time data available throughout the days 1-3 dosing period (pharmacokinetic population). Safety, a secondary endpoint, was assessed in enrolled patients who received at least one dose of study drug (safety population). As exploratory pharmacodynamic endpoints, we assessed E coli levels in urine and clinical symptoms of UTI in patients with at least 1·0 × 10<sup>5</sup> colony-forming units per mL E coli in urine at baseline who took at least one dose of study drug and completed their day 10 test-of-cure assessment (pharmacodynamic-evaluable population). This trial is registered with Clinical","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141972153","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 : 2024-08-07DOI: 10.1016/S1473-3099(24)00496-1
Concetta Castilletti, Antonio Mori, Elena Pomari, Andrea Matucci, Giulia Martelli, Salvatore Curiale, Andrea Angheben, Federico Giovanni Gobbi
{"title":"First diagnoses of Oropouche virus in Europe: how can we strengthen communication and preparedness globally?","authors":"Concetta Castilletti, Antonio Mori, Elena Pomari, Andrea Matucci, Giulia Martelli, Salvatore Curiale, Andrea Angheben, Federico Giovanni Gobbi","doi":"10.1016/S1473-3099(24)00496-1","DOIUrl":"https://doi.org/10.1016/S1473-3099(24)00496-1","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141914383","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 : 2024-08-07DOI: 10.1016/S1473-3099(24)00374-8
Rebecca K Nash, Sangeeta Bhatia, Christian Morgenstern, Patrick Doohan, David Jorgensen, Kelly McCain, Ruth McCabe, Dariya Nikitin, Alpha Forna, Gina Cuomo-Dannenburg, Joseph T Hicks, Richard J Sheppard, Tristan Naidoo, Sabine van Elsland, Cyril Geismar, Thomas Rawson, Sequoia Iris Leuba, Jack Wardle, Isobel Routledge, Keith Fraser, Natsuko Imai-Eaton, Anne Cori, H Juliette T Unwin
Ebola virus disease poses a recurring risk to human health. We conducted a systematic review (PROSPERO CRD42023393345) of Ebola virus disease transmission models and parameters published from database inception to July 7, 2023, from PubMed and Web of Science. Two people screened each abstract and full text. Papers were extracted with a bespoke Access database, 10% were double extracted. We extracted 1280 parameters and 295 models from 522 papers. Basic reproduction number estimates were highly variable, as were effective reproduction numbers, likely reflecting spatiotemporal variability in interventions. Random-effect estimates were 15·4 days (95% CI 13·2-17·5) for the serial interval, 8·5 days (7·7-9·2) for the incubation period, 9·3 days (8·5-10·1) for the symptom-onset-to-death delay, and 13·0 days (10·4-15·7) for symptom-onset-to-recovery. Common effect estimates were similar, albeit with narrower CIs. Case-fatality ratio estimates were generally high but highly variable, which could reflect heterogeneity in underlying risk factors. Although a substantial body of literature exists on Ebola virus disease models and epidemiological parameter estimates, many of these studies focus on the west African Ebola epidemic and are primarily associated with Zaire Ebola virus, which leaves a key gap in our knowledge regarding other Ebola virus species and outbreak contexts.
埃博拉病毒疾病对人类健康构成经常性风险。我们从 PubMed 和 Web of Science 上对从数据库建立到 2023 年 7 月 7 日发表的埃博拉病毒疾病传播模型和参数进行了系统综述(PROSPERO CRD42023393345)。每篇论文的摘要和全文均由两人筛选。使用定制的 Access 数据库提取论文,10% 的论文进行了双重提取。我们从 522 篇论文中提取了 1280 个参数和 295 个模型。基本繁殖数量估计值和有效繁殖数量估计值差异很大,这可能反映了干预措施的时空差异性。随机效应估计值为:序列间隔 15-4 天(95% CI 13-2-17-5),潜伏期 8-5 天(7-7-9-2),症状发作到死亡延迟 9-3 天(8-5-10-1),症状发作到恢复 13-0 天(10-4-15-7)。共同效应估计值相似,但 CI 值较小。病死率估计值普遍较高,但变化很大,这可能反映了潜在风险因素的异质性。尽管已有大量关于埃博拉病毒疾病模型和流行病学参数估计的文献,但其中许多研究都集中在西非埃博拉疫情上,而且主要与扎伊尔埃博拉病毒有关,这使我们对其他埃博拉病毒种类和疫情背景的了解存在重大差距。
{"title":"Ebola virus disease mathematical models and epidemiological parameters: a systematic review.","authors":"Rebecca K Nash, Sangeeta Bhatia, Christian Morgenstern, Patrick Doohan, David Jorgensen, Kelly McCain, Ruth McCabe, Dariya Nikitin, Alpha Forna, Gina Cuomo-Dannenburg, Joseph T Hicks, Richard J Sheppard, Tristan Naidoo, Sabine van Elsland, Cyril Geismar, Thomas Rawson, Sequoia Iris Leuba, Jack Wardle, Isobel Routledge, Keith Fraser, Natsuko Imai-Eaton, Anne Cori, H Juliette T Unwin","doi":"10.1016/S1473-3099(24)00374-8","DOIUrl":"https://doi.org/10.1016/S1473-3099(24)00374-8","url":null,"abstract":"<p><p>Ebola virus disease poses a recurring risk to human health. We conducted a systematic review (PROSPERO CRD42023393345) of Ebola virus disease transmission models and parameters published from database inception to July 7, 2023, from PubMed and Web of Science. Two people screened each abstract and full text. Papers were extracted with a bespoke Access database, 10% were double extracted. We extracted 1280 parameters and 295 models from 522 papers. Basic reproduction number estimates were highly variable, as were effective reproduction numbers, likely reflecting spatiotemporal variability in interventions. Random-effect estimates were 15·4 days (95% CI 13·2-17·5) for the serial interval, 8·5 days (7·7-9·2) for the incubation period, 9·3 days (8·5-10·1) for the symptom-onset-to-death delay, and 13·0 days (10·4-15·7) for symptom-onset-to-recovery. Common effect estimates were similar, albeit with narrower CIs. Case-fatality ratio estimates were generally high but highly variable, which could reflect heterogeneity in underlying risk factors. Although a substantial body of literature exists on Ebola virus disease models and epidemiological parameter estimates, many of these studies focus on the west African Ebola epidemic and are primarily associated with Zaire Ebola virus, which leaves a key gap in our knowledge regarding other Ebola virus species and outbreak contexts.</p>","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141914381","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 : 2024-08-05DOI: 10.1016/S1473-3099(24)00434-1
Annika B Wilder-Smith, David O Freedman, Annelies Wilder-Smith
{"title":"Edging towards a third dengue vaccine.","authors":"Annika B Wilder-Smith, David O Freedman, Annelies Wilder-Smith","doi":"10.1016/S1473-3099(24)00434-1","DOIUrl":"https://doi.org/10.1016/S1473-3099(24)00434-1","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908184","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 : 2024-08-05DOI: 10.1016/S1473-3099(24)00376-1
Mauricio L Nogueira, Monica A T Cintra, José A Moreira, Elizabeth G Patiño, Patricia Emilia Braga, Juliana C V Tenório, Lucas Bassolli de Oliveira Alves, Vanessa Infante, Daniela Haydee Ramos Silveira, Marcus Vínicius Guimarães de Lacerda, Dhelio Batista Pereira, Allex Jardim da Fonseca, Ricardo Queiroz Gurgel, Ivo Castelo-Branco Coelho, Cor Jesus Fernandes Fontes, Ernesto T A Marques, Gustavo Adolfo Sierra Romero, Mauro Martins Teixeira, André M Siqueira, Viviane Sampaio Boaventura, Fabiano Ramos, Erivaldo Elias Júnior, José Cassio de Moraes, Stephen S Whitehead, Alejandra Esteves-Jaramillo, Tulin Shekar, Jung-Jin Lee, Julieta Macey, Sabrina Gozlan Kelner, Beth-Ann G Coller, Fernanda Castro Boulos, Esper G Kallás
Background: A single-dose dengue vaccine that protects individuals across a wide age range and regardless of dengue serostatus is an unmet need. We assessed the safety and efficacy of the live, attenuated, tetravalent Butantan-dengue vaccine (Butantan-DV) in adults, adolescents, and children. We previously reported the primary and secondary efficacy and safety endpoints in the initial 2 years of follow-up. Here we report the results through an extended follow-up period, with an average of 3·7 years of follow-up.
Methods: In this double-blind, randomised, placebo-controlled, phase 3, multicentre trial in Brazil, healthy participants (aged 2-59 years) who had not previously received a dengue vaccine were enrolled and randomly assigned 2:1 (stratified by age 18-59 years, 7-17 years, and 2-6 years) using a central electronic randomisation system to receive 0·5 mL of Butantan-DV (containing approximately 103 plaque-forming units of each of the four vaccine virus strains) or placebo, administered subcutaneously. Syringes containing vaccine or placebo were prepared by an unmasked trial pharmacist who was not involved in any subsequent participant assessments; other site staff and the participants remained unaware of the group allocations. Vaccine efficacy was calculated with the accrual of virologically confirmed dengue (VCD) cases (by RT-PCR) at least 28 days after vaccination up until the cutoff (at least 2 years of follow-up from the last participant enrolled). The primary endpoint was vaccine efficacy against VCD after day 28 by any dengue virus (DENV) serotype regardless of dengue serostatus at baseline in the per-protocol population. The primary and secondary safety endpoints up until day 21 were previously reported; secondary safety endpoints include the frequency of unsolicited vaccine-related adverse events after day 22. Safety analyses were done on all participants as treated. This trial is registered with ClinicalTrials.gov (NCT02406729) and is ongoing.
Findings: Of 16 363 participants assessed for eligibility, 16 235 were randomly assigned between Feb 22, 2016, and July 5, 2019, and received single-dose Butantan-DV (10 259 participants) or placebo (5976 participants). 16 162 participants (Butantan-DV n=10 215; placebo n=5947) were included in the per-protocol population and 16 235 (Butantan-DV n=10 259; placebo n=5976) in the safety population. At the data cutoff (July 13, 2021), participants had 2-5 years of follow-up (mean 3·7 years [SD 1·0], median 4·0 years [IQR 3·2-4·5]). 356 VCD cases were captured through the follow-up (128 in the vaccine group and 228 in the placebo group). Vaccine efficacy against VCD caused by any DENV serotype was 67·3% (95% CI 59·4-73·9); cases caused by DENV-3 or DENV-4 were not observed. The proportions of participants who had serious adverse events were similar between treatment groups (637 [6·2%] in the vaccine group and 395 [6·6%] i
{"title":"Efficacy and safety of Butantan-DV in participants aged 2-59 years through an extended follow-up: results from a double-blind, randomised, placebo-controlled, phase 3, multicentre trial in Brazil.","authors":"Mauricio L Nogueira, Monica A T Cintra, José A Moreira, Elizabeth G Patiño, Patricia Emilia Braga, Juliana C V Tenório, Lucas Bassolli de Oliveira Alves, Vanessa Infante, Daniela Haydee Ramos Silveira, Marcus Vínicius Guimarães de Lacerda, Dhelio Batista Pereira, Allex Jardim da Fonseca, Ricardo Queiroz Gurgel, Ivo Castelo-Branco Coelho, Cor Jesus Fernandes Fontes, Ernesto T A Marques, Gustavo Adolfo Sierra Romero, Mauro Martins Teixeira, André M Siqueira, Viviane Sampaio Boaventura, Fabiano Ramos, Erivaldo Elias Júnior, José Cassio de Moraes, Stephen S Whitehead, Alejandra Esteves-Jaramillo, Tulin Shekar, Jung-Jin Lee, Julieta Macey, Sabrina Gozlan Kelner, Beth-Ann G Coller, Fernanda Castro Boulos, Esper G Kallás","doi":"10.1016/S1473-3099(24)00376-1","DOIUrl":"https://doi.org/10.1016/S1473-3099(24)00376-1","url":null,"abstract":"<p><strong>Background: </strong>A single-dose dengue vaccine that protects individuals across a wide age range and regardless of dengue serostatus is an unmet need. We assessed the safety and efficacy of the live, attenuated, tetravalent Butantan-dengue vaccine (Butantan-DV) in adults, adolescents, and children. We previously reported the primary and secondary efficacy and safety endpoints in the initial 2 years of follow-up. Here we report the results through an extended follow-up period, with an average of 3·7 years of follow-up.</p><p><strong>Methods: </strong>In this double-blind, randomised, placebo-controlled, phase 3, multicentre trial in Brazil, healthy participants (aged 2-59 years) who had not previously received a dengue vaccine were enrolled and randomly assigned 2:1 (stratified by age 18-59 years, 7-17 years, and 2-6 years) using a central electronic randomisation system to receive 0·5 mL of Butantan-DV (containing approximately 10<sup>3</sup> plaque-forming units of each of the four vaccine virus strains) or placebo, administered subcutaneously. Syringes containing vaccine or placebo were prepared by an unmasked trial pharmacist who was not involved in any subsequent participant assessments; other site staff and the participants remained unaware of the group allocations. Vaccine efficacy was calculated with the accrual of virologically confirmed dengue (VCD) cases (by RT-PCR) at least 28 days after vaccination up until the cutoff (at least 2 years of follow-up from the last participant enrolled). The primary endpoint was vaccine efficacy against VCD after day 28 by any dengue virus (DENV) serotype regardless of dengue serostatus at baseline in the per-protocol population. The primary and secondary safety endpoints up until day 21 were previously reported; secondary safety endpoints include the frequency of unsolicited vaccine-related adverse events after day 22. Safety analyses were done on all participants as treated. This trial is registered with ClinicalTrials.gov (NCT02406729) and is ongoing.</p><p><strong>Findings: </strong>Of 16 363 participants assessed for eligibility, 16 235 were randomly assigned between Feb 22, 2016, and July 5, 2019, and received single-dose Butantan-DV (10 259 participants) or placebo (5976 participants). 16 162 participants (Butantan-DV n=10 215; placebo n=5947) were included in the per-protocol population and 16 235 (Butantan-DV n=10 259; placebo n=5976) in the safety population. At the data cutoff (July 13, 2021), participants had 2-5 years of follow-up (mean 3·7 years [SD 1·0], median 4·0 years [IQR 3·2-4·5]). 356 VCD cases were captured through the follow-up (128 in the vaccine group and 228 in the placebo group). Vaccine efficacy against VCD caused by any DENV serotype was 67·3% (95% CI 59·4-73·9); cases caused by DENV-3 or DENV-4 were not observed. The proportions of participants who had serious adverse events were similar between treatment groups (637 [6·2%] in the vaccine group and 395 [6·6%] i","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908185","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 : 2024-08-02DOI: 10.1016/S1473-3099(24)00498-5
Francesco Branda, Massimo Ciccozzi, Fabio Scarpa
{"title":"Tracking the spread of avian influenza A(H5N1) with alternative surveillance methods: the example of wastewater data.","authors":"Francesco Branda, Massimo Ciccozzi, Fabio Scarpa","doi":"10.1016/S1473-3099(24)00498-5","DOIUrl":"https://doi.org/10.1016/S1473-3099(24)00498-5","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141894776","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 : 2024-08-01Epub Date: 2024-07-04DOI: 10.1016/S1473-3099(24)00418-3
Maria Eugenia Toledo, Sonia Monteagudo Diaz, Tamara Montenegro Calderón, Katharina Kreppel, Eline Van Damme, Veerle Vanlerberghe
{"title":"Preparedness for emerging epidemic threats: detection of Oropouche circulation in Cuba.","authors":"Maria Eugenia Toledo, Sonia Monteagudo Diaz, Tamara Montenegro Calderón, Katharina Kreppel, Eline Van Damme, Veerle Vanlerberghe","doi":"10.1016/S1473-3099(24)00418-3","DOIUrl":"10.1016/S1473-3099(24)00418-3","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555742","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}