Richard G White, Gavin J Churchyard, Katherine C Horton, Andrew Fiore-Gartland, Marcel A Behr, Rebecca A Clark, Frank Cobelens, Joel D Ernst, Hanif Esmail, Alberto L Garcia-Basteiro, Sri Rezeki Hadinegoro, Willem A Hanekom, Mark Hatherill, Philip C Hill, Rudzani Muloiwa, Puck T Pelzer, Lele Rangaka, Helen Rees, Lewis Schrager, Margaret Stanley, Rein M G J Houben
{"title":"评估将细菌学证实的无症状结核病作为预防结核病疫苗许可试验的主要终点所需的证据","authors":"Richard G White, Gavin J Churchyard, Katherine C Horton, Andrew Fiore-Gartland, Marcel A Behr, Rebecca A Clark, Frank Cobelens, Joel D Ernst, Hanif Esmail, Alberto L Garcia-Basteiro, Sri Rezeki Hadinegoro, Willem A Hanekom, Mark Hatherill, Philip C Hill, Rudzani Muloiwa, Puck T Pelzer, Lele Rangaka, Helen Rees, Lewis Schrager, Margaret Stanley, Rein M G J Houben","doi":"10.1016/s2213-2600(25)00164-x","DOIUrl":null,"url":null,"abstract":"Current licensure trials of new vaccines to prevent tuberculosis disease use bacteriologically confirmed symptomatic tuberculosis disease as the primary endpoint. Globally, the incidence of symptomatic tuberculosis disease is low, making licensure trials large, long, and expensive. New data suggest that bacteriologically confirmed asymptomatic tuberculosis disease might occur more frequently than symptomatic tuberculosis disease. Therefore, if vaccines have efficacy against asymptomatic disease, tuberculosis vaccine licensure trials could include it in the primary endpoint, potentially leading to smaller or shorter trials. We describe the potential benefits and risks of this inclusion in the primary endpoint of tuberculosis vaccine licensure trials. We also simulate licensure trial endpoint accrual and summarise feedback from anonymous regulators and policy makers on the knowledge needed to consider this proposal and research studies needed to fill these evidence gaps. If bacteriologically confirmed asymptomatic tuberculosis disease could be included in the primary endpoint of tuberculosis disease licensure trials, it could lead to cheaper and more rapid tuberculosis vaccine development.","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"1 1","pages":""},"PeriodicalIF":38.7000,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evidence required to evaluate the use of bacteriologically confirmed asymptomatic tuberculosis disease as a primary endpoint in prevention of tuberculosis disease vaccine licensure trials\",\"authors\":\"Richard G White, Gavin J Churchyard, Katherine C Horton, Andrew Fiore-Gartland, Marcel A Behr, Rebecca A Clark, Frank Cobelens, Joel D Ernst, Hanif Esmail, Alberto L Garcia-Basteiro, Sri Rezeki Hadinegoro, Willem A Hanekom, Mark Hatherill, Philip C Hill, Rudzani Muloiwa, Puck T Pelzer, Lele Rangaka, Helen Rees, Lewis Schrager, Margaret Stanley, Rein M G J Houben\",\"doi\":\"10.1016/s2213-2600(25)00164-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Current licensure trials of new vaccines to prevent tuberculosis disease use bacteriologically confirmed symptomatic tuberculosis disease as the primary endpoint. 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If bacteriologically confirmed asymptomatic tuberculosis disease could be included in the primary endpoint of tuberculosis disease licensure trials, it could lead to cheaper and more rapid tuberculosis vaccine development.\",\"PeriodicalId\":51307,\"journal\":{\"name\":\"Lancet Respiratory Medicine\",\"volume\":\"1 1\",\"pages\":\"\"},\"PeriodicalIF\":38.7000,\"publicationDate\":\"2025-07-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Lancet Respiratory Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/s2213-2600(25)00164-x\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lancet Respiratory Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/s2213-2600(25)00164-x","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
Evidence required to evaluate the use of bacteriologically confirmed asymptomatic tuberculosis disease as a primary endpoint in prevention of tuberculosis disease vaccine licensure trials
Current licensure trials of new vaccines to prevent tuberculosis disease use bacteriologically confirmed symptomatic tuberculosis disease as the primary endpoint. Globally, the incidence of symptomatic tuberculosis disease is low, making licensure trials large, long, and expensive. New data suggest that bacteriologically confirmed asymptomatic tuberculosis disease might occur more frequently than symptomatic tuberculosis disease. Therefore, if vaccines have efficacy against asymptomatic disease, tuberculosis vaccine licensure trials could include it in the primary endpoint, potentially leading to smaller or shorter trials. We describe the potential benefits and risks of this inclusion in the primary endpoint of tuberculosis vaccine licensure trials. We also simulate licensure trial endpoint accrual and summarise feedback from anonymous regulators and policy makers on the knowledge needed to consider this proposal and research studies needed to fill these evidence gaps. If bacteriologically confirmed asymptomatic tuberculosis disease could be included in the primary endpoint of tuberculosis disease licensure trials, it could lead to cheaper and more rapid tuberculosis vaccine development.
期刊介绍:
The Lancet Respiratory Medicine is a renowned journal specializing in respiratory medicine and critical care. Our publication features original research that aims to advocate for change or shed light on clinical practices in the field. Additionally, we provide informative reviews on various topics related to respiratory medicine and critical care, ensuring a comprehensive coverage of the subject.
The journal covers a wide range of topics including but not limited to asthma, acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD), tobacco control, intensive care medicine, lung cancer, cystic fibrosis, pneumonia, sarcoidosis, sepsis, mesothelioma, sleep medicine, thoracic and reconstructive surgery, tuberculosis, palliative medicine, influenza, pulmonary hypertension, pulmonary vascular disease, and respiratory infections. By encompassing such a broad spectrum of subjects, we strive to address the diverse needs and interests of our readership.