Tuberculosis (TB) remains a major health threat. Although a vaccine has been available for almost 100 years termed Bacille Calmette-Guérin (BCG), it is insufficient and better vaccines are urgently needed. This treatise describes first the basic immunology and pathology of TB with an emphasis on the role of T lymphocytes. Better understanding of the immune response to Mycobacterium tuberculosis (Mtb) serves as blueprint for rational design of TB vaccines. Then, disease epidemiology and the benefits and failures of BCG vaccination will be presented. Next, types of novel vaccine candidates are being discussed. These include: (i) antigen/adjuvant subunit vaccines; (ii) viral vectored vaccines; and (III) whole cell mycobacterial vaccines which come as live recombinant vaccines or as dead whole cell or multi-component vaccines. Subsequently, the major endpoints of clinical trials as well as administration schemes are being described. Major endpoints for clinical trials are prevention of infection (PoI), prevention of disease (PoD), and prevention of recurrence (PoR). Vaccines can be administered either pre-exposure or post-exposure with Mtb. A central part of this treatise is the description of the viable BCG-based vaccine, VPM1002, currently undergoing phase III clinical trial assessment. Finally, new approaches which could facilitate design of refined next generation TB vaccines will be discussed.

结核病 (TB) 仍然是一个主要的健康威胁。尽管卡介苗 (BCG) 疫苗问世已有近 100 年，但它还不够，迫切需要更好的疫苗。这篇论文首先描述了结核病的基本免疫学和病理学，重点介绍了 T 淋巴细胞的作用。更好地了解免疫反应结核分枝杆菌 (Mtb)为结核病疫苗的合理设计提供蓝图。然后，将介绍疾病流行病学以及卡介苗疫苗接种的好处和失败。接下来，正在讨论新型候选疫苗的类型。这些包括： (i) 抗原/佐剂亚单位疫苗；(ii) 病毒载体疫苗；(III) 全细胞分枝杆菌疫苗，其为活重组疫苗或死全细胞或多组分疫苗。随后，描述了临床试验的主要终点以及给药方案。临床试验的主要终点是预防感染（PoI）、预防疾病（PoD）和预防复发（PoR）。疫苗可以在暴露前或暴露后接种山地车。这篇论文的核心部分是对基于 BCG 的可行疫苗 VPM1002 的描述，该疫苗目前正在进行 III 期临床试验评估。最后，将讨论有助于设计改良的下一代结核病疫苗的新方法。