本文针对以卡介苗(bacillus Calmette-Guérin，BCG)为基础的结核分枝杆菌新疫苗本身的缺陷问题、临床前药效学评价面临的问题、临床研究可能面临的有效性评价问题及伦理问题等，对“新一代抗结核分枝杆菌疫苗将会建立在现用BCG的基础上”的观点进行评述。认为以BCG为基础的新疫苗保护力可能超过现用BCG，但要显著提高其对成人的保护效果尚有难度；新疫苗用于新生儿的临床研究因存在伦理问题而可能无法开展；针对潜伏结核感染人群的免疫预防是控制结核病的重要手段，以现用BCG为基础的新疫苗可能无法应用于此类人群。因此，新一代主流抗结核分枝杆菌疫苗将不会是建立在现用BCG基础之上的疫苗。

One of the major efforts for the next generation vaccine for tuberculosis prevention is based upon bacillus Calmette-Guérin (BCG). The potential limitations and practical concerns regarding “new generation tuberculosis vaccine based on BCG” are presented in this paper. The practical challenge in designing, the concerns for preclinical pharmacodynamic evaluation and effective clinical evaluation are discussed. We concluded that although a new BCG-based vaccine may reach the goal for better protection than the current BCG, it is difficult to significantly improve the protection for adults. The trials of new vaccines in newborns may not be conducted due to the ethical issues. Control of latent tuberculosis infection is a key step for the prevention of tuberculosis and the new vaccines may not be applied in this population. Therefore, we need new strategies for new generation of mainstream tuberculosis vaccines as there are significant hurdles on the path for BCG-based research and development.