Sadigurschi Gabriela, Kuschnir Maria Cristina Caetano, Dos Santos Ewerton Alves Portela, da Silva Bruno Rangel Antunes, Marques Celia Menezes Cruz, de Andrade Raissa Coelho, Vianna Clarice Monteiro, de Barros Danillo Gonçalves, Mazzi Mariana Torres, Lago Elvira Alonso, Dos Santos Eliane Matos, Maia Maria de Lourdes de Sousa
Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos/Bio-Manguinhos, Departamento de Assuntos Médicos, Estudos Clínicos e Vigilância Pós-Registro, Rio de Janeiro, RJ, Brasil.
Universidade do Estado do Rio de Janeiro, Hospital Universitário Pedro Ernesto, Rio de Janeiro, RJ, Brasil.
Mem Inst Oswaldo Cruz. 2025 Jun 9;120:e240236. doi: 10.1590/0074-02760240236. eCollection 2025.
Tuberculosis (TB) is a preventable and curable disease caused by the bacillus Mycobacterium tuberculosis. In 2022, according to the World Health Organisation (WHO), TB was the second leading cause of death worldwide caused by a single infectious agent, after coronavirus disease (COVID-19). Brazil is ranked among the 30 countries with the highest TB burden. Currently, the neonatal Bacillus Calmette-Guérin (BCG) is the only vaccine against TB and offers significant efficacy against disseminated and meningeal disease in children. However, BCG has a limited efficacy in preventing adult-type cavitary TB, reinforcing the need for a new effective vaccine against pulmonary TB. There are currently over 22 TB vaccines under evaluation in clinical trials worldwide. Despite significant advancements, several challenges persist in developing and producing an effective TB vaccine. These include understanding the immune mechanisms that confer protection against M. tuberculosis, identifying immune correlates of protection, defining immune responses in BCG-vaccinated individuals, establishing efficacy endpoints for TB vaccine trials, and ensuring vaccine safety and effectiveness in individuals with human immunodeficiency virus (HIV), among other obstacles. Therefore, this study aims to explore the key obstacles in developing new TB vaccines and potential strategies to overcome them.
结核病（TB）是一种由结核分枝杆菌引起的可预防、可治愈的疾病。2022年，据世界卫生组织（WHO）称，结核病是全球仅次于冠状病毒病（COVID-19）的由单一传染源导致的第二大死因。巴西位列结核病负担最高的30个国家之中。目前，新生儿卡介苗（BCG）是唯一的抗结核病疫苗，对预防儿童播散性和脑膜疾病具有显著疗效。然而，卡介苗在预防成人型空洞性结核病方面疗效有限，这凸显了研发新型有效抗肺结核疫苗的必要性。目前全球有超过22种结核病疫苗正在临床试验中接受评估。尽管取得了重大进展，但在研发和生产有效的结核病疫苗方面仍存在一些挑战。这些挑战包括了解赋予抗结核分枝杆菌保护作用的免疫机制、确定保护的免疫相关指标、明确接种卡介苗个体的免疫反应、确定结核病疫苗试验的疗效终点，以及确保疫苗在人类免疫缺陷病毒（HIV）感染者中的安全性和有效性等诸多障碍。因此，本研究旨在探讨研发新型结核病疫苗的关键障碍以及克服这些障碍的潜在策略。
