对研发新型结核病疫苗的分析和展望

结核病是公共卫生当前面临的重要问题。由于BCG预防效果不佳,研究和开发新型结核病疫苗显得必须且急迫。新型结核病疫苗的研究开发路径和观念也经历了变迁,当前主流的研发路径有重组BCG或重组结核菌、重组痘病毒或重组腺病毒载体疫苗、蛋白质亚单位或重组融合蛋白质亚单位疫苗三类,它们在疫苗效力前景,抗原选型、配方、剂型,免疫应答,疫苗生产,疫苗质量控制,临床前研究动物试验,临床试验和使用,对结核病公共卫生政策的影响等方面各有优劣。新型结核病疫苗的成功研发,还需要病原学、发病机制、免疫学和疫苗研发科学的进一步努力。

Analysis and prospect for research and development of new tuberculosis vaccines

Tuberculosis（TB） is an infectious disease caused by the bacillus Mycobacterium tuberculosis.It is one of the most challenging infectious diseases still affecting human facing by the public health.The partial effectiveness of the existing TB vaccine,bacillede Calmette Guérin（BCG）,suggests effective vaccination is possible and highlights the need for an improved vaccination strategy.The researching routes and aspects for new TB vaccines have changed a lot in recent twenty years.The current main routes include the development of the recombinant BCG or attenuated Mycobacterium tuberculosis,the recombinant vaccinia virus or recombinant adenovirus,and the protein antigen or recombinant protein subunit vaccines.There are advantages and disadvantages for each of these vaccines in vaccine efficacy,antigenic selection and formulation,immune response,manufacturing,quality control,preclinical animal study,clinical human trial,post licensure clinical administration,even in the impact to TB public health regulations.These will determine which will contribute to the public health more currently and more easily being accepted.The success of new TB vaccines is still need further efforts in etiology,pathogenesis,immunology and vaccinology.