目的  对两个工作种子批菌种D2-甲12制备的两批冻干卡介苗接种人体后的安全性和效果进行临床考核。 方法  对100名结核杆菌纯化蛋白衍生物（PPD）皮肤试验阴性的3月龄~50岁健康对象和205名新生儿分别接种上述两个批次的观察疫苗和一个对照疫苗。观察接种后的局部和全身反应，测量卡痕，并对新生儿进行PPD皮肤试验。采用χ²检验和t检验对新生儿各组间的卡痕和PPD试验结果进行比较。结果  所有对象接种后均未发现接种部位和全身不良反应。新生儿卡痕均值≥4.6 mm，PPD硬结均值≥6.8 mm。卡痕和PPD试验阳性率均超过90%，两者在新生儿各组间的差异均无统计学意义（χ² =0.001~1.713，P=0.191~1.000）。卡痕均值和PPD硬结均值在两个观察疫苗组间的差异无统计学意义（t=0.773，P=0.441；t=0.226，P=0.822），而对照疫苗组与两个观察疫苗组间的差异均有统计学意义（t=2.645~3.361，P=0.001~0.010）。  结论  两个工作种子批菌种D2-甲12制备的卡介苗接种人体是安全的，并具有良好的接种效果。

Objection  To investigate safety and the immune effect of lyophilized BCG vaccines produced by two working seed lots in a clinical trial.  Methods  One hundred healthy subjects aged 3 months to 50 years old with negative purified protein derivative (PPD) skin test and 205 neonates were immunized with the above two test vaccines and a control vaccine. Local and systemic reactions were investigated and BCG scar size was measured. PPD skin test was performed in the neonatal infants.χ² and t tests were adopted for comparison of BCG scar sizes and PPD test results among 3 neonatal groups.  Results  No local or systemic adverse reactions were observed in all subjects. In the neonates, the average diameters of BCG scars and PPD indurations were ≥0.46 mm and ≥0.68 mm, respectively. Both the positive rates of BCG scar and PPD test were >90%. No statistically significant differences in the positive rates of BCG scar and PPD test were found among 3 neonatal groups （χ²=0.001~1.713，P=0.191~1.000）. The average diameters of BCG scars and PPD indurations were no significantly different between 2 test vaccine groups （t=0.773，P=0.441；t=0.226，P=0.822）, but the statistical differences were observed between the control group and 2 test groups （t=2.645~3.361，P=0.001~0.010）.  Conclusion  The lyophilized BCG vaccines prepared by two working seed lots are proved to be safe and immunologically effective for human immunization.