Pub Date : 2024-11-01Epub Date: 2024-07-03DOI: 10.1016/S1473-3099(24)00339-6
Else M Bijker, Lyn Horn, Sylvia LaCourse, Emily L MacLean, Ben J Marais, Mark P Nicol, Laura Olbrich, James A Seddon, Jayne S Sutherland, Rinn Song, Heather J Zar, Devan Jaganath
The diagnosis of paediatric tuberculosis remains a challenge due to the non-specificity of symptoms and the paucibacillary nature of tuberculosis in children. However, in the development of new tuberculosis diagnostics, the unique needs of children and adolescents are rarely considered in the design process, with delays in evaluation and approval. No clear guidance is available on when and how to include children and adolescents in tuberculosis diagnostic development and evaluation. To address this gap, we conducted a Delphi consensus process with 42 stakeholders, including one qualitative and two quantitative rounds. Consensus was achieved on 20 statements, with agreement that the needs and perspectives of children, adolescents, and their caregivers should be incorporated throughout diagnostic design and evaluation. Opportunities exist for the early use of well characterised samples and prospective enrolment of children and adolescents in tuberculosis diagnostic evaluation, with consideration of the type of test, expected benefit, and potential risks. Pathogen-based tests might be initially optimised and assessed in adults and adolescents, but parallel evaluation in children is needed for host-based tests. Late-stage evaluation and implementation studies should examine combination testing and integration into clinical algorithms. The statements support collaboration between developers, researchers, regulators, and users to widen and accelerate the diagnostic pipeline for paediatric tuberculosis.
{"title":"The inclusion of children and adolescents in tuberculosis diagnostic development and evaluation-a consensus statement.","authors":"Else M Bijker, Lyn Horn, Sylvia LaCourse, Emily L MacLean, Ben J Marais, Mark P Nicol, Laura Olbrich, James A Seddon, Jayne S Sutherland, Rinn Song, Heather J Zar, Devan Jaganath","doi":"10.1016/S1473-3099(24)00339-6","DOIUrl":"10.1016/S1473-3099(24)00339-6","url":null,"abstract":"<p><p>The diagnosis of paediatric tuberculosis remains a challenge due to the non-specificity of symptoms and the paucibacillary nature of tuberculosis in children. However, in the development of new tuberculosis diagnostics, the unique needs of children and adolescents are rarely considered in the design process, with delays in evaluation and approval. No clear guidance is available on when and how to include children and adolescents in tuberculosis diagnostic development and evaluation. To address this gap, we conducted a Delphi consensus process with 42 stakeholders, including one qualitative and two quantitative rounds. Consensus was achieved on 20 statements, with agreement that the needs and perspectives of children, adolescents, and their caregivers should be incorporated throughout diagnostic design and evaluation. Opportunities exist for the early use of well characterised samples and prospective enrolment of children and adolescents in tuberculosis diagnostic evaluation, with consideration of the type of test, expected benefit, and potential risks. Pathogen-based tests might be initially optimised and assessed in adults and adolescents, but parallel evaluation in children is needed for host-based tests. Late-stage evaluation and implementation studies should examine combination testing and integration into clinical algorithms. The statements support collaboration between developers, researchers, regulators, and users to widen and accelerate the diagnostic pipeline for paediatric tuberculosis.</p>","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"e688-e695"},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141545453","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 : 2024-11-01Epub 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
<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
{"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":"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":" ","pages":"1234-1244"},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","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 : 2024-11-01Epub Date: 2024-08-16DOI: 10.1016/S1473-3099(24)00413-4
Eulambius M Mlugu, Arjen M Dondorp, Karen I Barnes
{"title":"Resistant malaria parasites gaining momentum in Africa.","authors":"Eulambius M Mlugu, Arjen M Dondorp, Karen I Barnes","doi":"10.1016/S1473-3099(24)00413-4","DOIUrl":"10.1016/S1473-3099(24)00413-4","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"1181-1182"},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142005632","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 : 2024-11-01Epub Date: 2024-09-10DOI: 10.1016/S1473-3099(24)00585-1
Mairead G Whelan, Harriet Ware, Himanshu Ranka, Sean Kenny, Sabah Shaikh, Yannik Roell, Shaila Akter, Anabel Selemon, Emilie Toews, May Chu, Niklas Bobrovitz, Rahul K Arora, Thomas Jaenisch
{"title":"ArboTracker: a multipathogen dashboard and data platform for arbovirus seroprevalence studies.","authors":"Mairead G Whelan, Harriet Ware, Himanshu Ranka, Sean Kenny, Sabah Shaikh, Yannik Roell, Shaila Akter, Anabel Selemon, Emilie Toews, May Chu, Niklas Bobrovitz, Rahul K Arora, Thomas Jaenisch","doi":"10.1016/S1473-3099(24)00585-1","DOIUrl":"10.1016/S1473-3099(24)00585-1","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"e670-e671"},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142299639","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 : 2024-11-01Epub Date: 2024-09-09DOI: 10.1016/S1473-3099(24)00571-1
Athina Samara, Conrado Milani Coutinho, Philip Veal, Jane Osborne, Geraldo Duarte, Shamez Ladhani, Asma Khalil
{"title":"Potential vertical transmission of Oropouche virus during the current outbreak.","authors":"Athina Samara, Conrado Milani Coutinho, Philip Veal, Jane Osborne, Geraldo Duarte, Shamez Ladhani, Asma Khalil","doi":"10.1016/S1473-3099(24)00571-1","DOIUrl":"10.1016/S1473-3099(24)00571-1","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"e668-e669"},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142299649","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 : 2024-11-01Epub Date: 2024-09-20DOI: 10.1016/S1473-3099(24)00607-8
Joseph D Tucker
{"title":"Financing infectious disease services in hospitals: a common public good.","authors":"Joseph D Tucker","doi":"10.1016/S1473-3099(24)00607-8","DOIUrl":"10.1016/S1473-3099(24)00607-8","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"e677"},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308942","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 : 2024-11-01Epub Date: 2024-07-25DOI: 10.1016/S1473-3099(24)00428-6
Saskia Bronder, Martina Sester
{"title":"A promising boost for the Rift Valley fever vaccine pipeline.","authors":"Saskia Bronder, Martina Sester","doi":"10.1016/S1473-3099(24)00428-6","DOIUrl":"10.1016/S1473-3099(24)00428-6","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"1184-1185"},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141789571","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 : 2024-11-01Epub Date: 2024-08-01DOI: 10.1016/S1473-3099(24)00451-1
Rosanne Sprute, Oliver A Cornely
{"title":"Lessons learnt from conducting a randomised clinical trial in eumycetoma.","authors":"Rosanne Sprute, Oliver A Cornely","doi":"10.1016/S1473-3099(24)00451-1","DOIUrl":"10.1016/S1473-3099(24)00451-1","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"1186-1187"},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890721","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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