ABSTRACT

Introduction: Global perception of the potential for Bacille Calmette-Guérin (BCG), and consequently recombinant BCG (rBCG), in a variety of prophylactic and therapeutic applications has been increasing. A century of information on BCG, and three decades of experience with rBCG, has generated solid knowledge in this field.

Area covered: Here, we review the current state of knowledge of BCG and rBCG development. Molecular tools have facilitated the expression of a variety of molecules in BCG, with the aim of improving its efficacy as a tuberculosis vaccine, generating polyvalent vaccines against other pathogens, including viruses, bacteria, and parasites, and developing immunotherapy approaches against noninvasive bladder cancer. BCG’s recently appraised heterologous effects and prospects for expanding its application to other diseases are also addressed.

Expert opinion: There are high expectations for new tuberculosis vaccines currently undergoing advanced clinical trials, which could change the prospects of the field. Systems biology could reveal effective biomarkers of protection, which would greatly support vaccine development. The development of appropriate large-scale production processes would further support implementation of new vaccines and rBCG products. The next few years should consolidate the broader applications of BCG and produce insights into improvements using the recombinant BCG technology.

摘要

简介：全球对卡介苗 (BCG) 以及重组卡介苗 (rBCG) 在各种预防和治疗应用中的潜力的认识不断增加。一个世纪关于 BCG 的信息，以及 30 年 rBCG 的经验，已经在该领域产生了扎实的知识。

涵盖的领域：在这里，我们回顾了 BCG 和 rBCG 开发的当前知识状态。分子工具促进了卡介苗中多种分子的表达，旨在提高其作为结核病疫苗的功效，产生针对其他病原体（包括病毒、细菌和寄生虫）的多价疫苗，并开发针对非侵袭性膀胱癌的免疫治疗方法。还讨论了 BCG 最近评估的异源效应以及将其扩展到其他疾病的前景。

专家意见：对目前正在进行高级临床试验的新型结核病疫苗寄予厚望，这可能会改变该领域的前景。系统生物学可以揭示有效的保护生物标志物，这将极大地支持疫苗的开发。开发适当的大规模生产工艺将进一步支持新疫苗和 rBCG 产品的实施。未来几年应该巩固 BCG 的更广泛应用，并产生使用重组 BCG 技术改进的见解。