Evidence required to evaluate the use of bacteriologically confirmed asymptomatic tuberculosis disease as a primary endpoint in prevention of tuberculosis disease vaccine licensure trials

IF 38.7 1区医学 Q1 CRITICAL CARE MEDICINE

Lancet Respiratory Medicine Pub Date : 2025-07-03 DOI:10.1016/s2213-2600(25)00164-x

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

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引用次数: 0

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.

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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

目前预防结核病的新疫苗的许可试验使用细菌学证实的症状性结核病作为主要终点。在全球范围内，有症状结核病的发病率很低，这使得许可试验规模大、时间长、费用高。新的数据表明，细菌学证实的无症状结核病可能比有症状的结核病更频繁发生。因此，如果疫苗对无症状疾病有效，结核病疫苗许可试验可将其纳入主要终点，可能导致更小或更短的试验。我们描述了将此纳入结核病疫苗许可试验主要终点的潜在益处和风险。我们还模拟了许可试验终点的累积，并总结了匿名监管机构和政策制定者对考虑该提案所需知识的反馈，以及填补这些证据空白所需的研究。如果细菌学证实的无症状结核病可以纳入结核病许可试验的主要终点，它可能导致更便宜和更快速的结核病疫苗开发。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Lancet Respiratory Medicine RESPIRATORY SYSTEM-RESPIRATORY SYSTEM

CiteScore

87.10

自引率

0.70%

发文量

572

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.