Aurum Institute NPC, Houghton, Parktown, South Africa; Department of Medicine, Vanderbilt University, Nashville, TN, USA; School of Public Health, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK; TB Modelling Group, TB Centre, London School of Hygiene & Tropical Medicine, London, UK.
Lancet Microbe. 2024 Oct;5(10):100895. doi: 10.1016/S2666-5247(24)00127-7. Epub 2024 Jul 1.
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.
结核病是全球由感染性病原体导致的主要死亡原因。在全国结核病流行调查中，传染性亚临床结核病几乎占所有结核病病例的一半，可能会导致传播，并可能与发病有关。模型研究表明，新的结核病疫苗可能会产生重大的健康和经济效益，部分依据是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疾病预防型结核病疫苗的效果是当务之急。将亚临床结核病纳入结核病疫苗试验的综合终点，可以帮助减少样本量和随访时间，并评估结核病疫苗预防临床和亚临床结核病的效果。在这方面有几种设计方案可供选择，这些方案具有不同的优点、局限性和伦理考虑，这将有助于产生估计结核病疫苗试验的积极全球效果所需的证据，同时为政策和疫苗接种策略提供信息。
