Implications of subclinical tuberculosis for vaccine trial design and global effect

IF 20.9 1区 生物学 Q1 INFECTIOUS DISEASES Lancet Microbe Pub Date : 2024-10-01 DOI:10.1016/S2666-5247(24)00127-7
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Abstract

Tuberculosis is a leading cause of death from an infectious agent globally. Infectious subclinical tuberculosis accounts for almost half of all tuberculosis cases in national tuberculosis prevalence surveys, and possibly contributes to transmission and might be associated with morbidity. Modelling studies suggest that new tuberculosis vaccines could have substantial health and economic effects, partly based on the assumptions made regarding subclinical tuberculosis. Evaluating the efficacy of prevention of disease tuberculosis vaccines intended for preventing both clinical and subclinical tuberculosis is a priority. Incorporation of subclinical tuberculosis as a composite endpoint in tuberculosis vaccine trials can help to reduce the sample size and duration of follow-up and to evaluate the efficacy of tuberculosis vaccines in preventing clinical and subclinical tuberculosis. Several design options with various benefits, limitations, and ethical considerations are possible in this regard, which would allow for the generation of the evidence needed to estimate the positive global effects of tuberculosis vaccine trials, in addition to informing policy and vaccination strategies.
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亚临床结核病对疫苗试验设计和全球效应的影响。
结核病是全球因传染性病原体致死的主要原因。在国家结核病发病率调查中,传染性亚临床结核病几乎占所有结核病病例的一半,可能会造成传播,也可能与发病率有关。模型研究表明,新的结核病疫苗可能会对健康和经济产生重大影响,这部分是基于对亚临床结核病的假设。评估旨在预防临床和亚临床结核病的结核病预防疫苗的功效是当务之急。将亚临床肺结核作为综合终点纳入结核病疫苗试验,有助于减少样本量和缩短随访时间,并评估结核病疫苗在预防临床和亚临床肺结核方面的疗效。在这方面,有几种设计方案具有不同的益处、局限性和伦理考虑因素,除了为政策和疫苗接种战略提供信息外,还能产生必要的证据来估计结核病疫苗试验的积极全球效应。
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来源期刊
Lancet Microbe
Lancet Microbe Multiple-
CiteScore
27.20
自引率
0.80%
发文量
278
审稿时长
6 weeks
期刊介绍: The Lancet Microbe is a gold open access journal committed to publishing content relevant to clinical microbiologists worldwide, with a focus on studies that advance clinical understanding, challenge the status quo, and advocate change in health policy.
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