目的以Balb/c小鼠为动物模型,评价重组卡介苗新型结核病疫苗rBCG-Ag85A-ESAT-6(rBC-AE)的免疫保护效应。方法将重组卡介苗rBCG-AE免疫动物10周后,结核分枝杆菌H37Rv尾静脉注射进行感染攻击,分别于感染攻击后3、6和9周,通过观察肺组织大体病变、脾肺组织细菌载荷量计数、肺组织抗酸染色、HE染色结合肺组织病理变化,综合评价该疫苗诱导的免疫保护作用。结果 rBCG-AE组脾肺组织细菌载荷量在各时间点均显著低于阴性对照组(PBST组,P<0.01),但明显高于卡介苗(BCG)组(P<0.01)。rBCG-AE组肺组织病变在感染攻击后6～9周逐渐改善,但其病理打分在各时间点均明显高于BCG组(P<0.01)。各组肺组织大体病变与组织病理打分变化相似。结论重组卡介苗rBCG-AE仅能诱导产生与BCG疫苗相当甚至较低的免疫保护作用。 Objective To evaluate the immunoprotective effect of recombinant BCG vaccine rBCG-Ag85A-ESAT-6 (rBC-AE) using Balb / c mice as an animal model. Methods The recombinant bacillus Calmette-Guerin (BCG) rBCG-AE was immunized for 10 weeks and then challenged with tail vein injection of Mycobacterium tuberculosis H37Rv. At 3, 6 and 9 weeks after infection, the pathological changes of lung tissue, bacterial load of spleen and lung Count, lung tissue acid-fast staining, HE staining combined with pathological changes of lung tissue, a comprehensive evaluation of the vaccine-induced immune protection. Results Bacterial load in spleen and lung of rBCG-AE group was significantly lower than that of negative control group (PBST group, P <0.01) at each time point, but significantly higher than that of BCG group (P <0.01). The lung lesions in rBCG-AE group gradually improved from 6 to 9 weeks after infection, but the pathological score of rBCG-AE group was significantly higher than that of BCG group at each time point (P <0.01). Lung lesions in all groups and histopathological score similar changes. Conclusion Recombinant BCG vaccine rBCG-AE can only induce a comparable or even lower immune protection than BCG vaccine.