冻干皮内注射用卡介苗的临床观察  

A clinical trial of lyophilized BCG vaccines for intradermal injection

作　　者：王琰[1] 肖亮明[2] 杨佳平[3] 李晓军[3] 王树巧[1] 

机构地区：[1]上海生物制品研究所有限责任公司第六研究室,200052 [2]上海生物制品研究所有限责任公司 质量保证部,200052 [3]上海市宝山区疾病预防控制中心计划免疫科,201900

出　　处：《国际生物制品学杂志》2012年第4期175-177,共3页International Journal of Biologicals

摘　　要：目的对两个工作种子批菌种D2-甲12制备的两批冻千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，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≥4．6mm，PPD硬结均值≥6．8mm。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（χ^2=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。Objective To investigate safety and immune effect of lyophilized BCG vaccines produced by 2 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 2 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 scar and PPD induration were ≥4.6 mm and ≥6.8 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 scar and PPD induration 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 immunologieally effective for human immunization.

关 键 词：卡介苗 工作种子批 安全性 接种 

分 类 号：R186[医药卫生—流行病学]