摘要
目的评价正常人群接种母牛分枝杆菌疫苗的安全性和细胞免疫学效果，探讨母牛分枝杆菌疫苗用于大龄儿童加强免疫，预防结核病的可行性。方法随机选择5～7岁的健康儿童，先进行结核菌素纯蛋白衍生物（TB-PPD）试验，然后分成TB-PPD试验阳性组和阴性组，每组分别接种母牛分枝杆菌疫苗3针，每针间隔2周。分别采集接种前和接种后1个月的血标本，用流式细胞仪检测各项细胞免疫学指标，观察两组免疫前后细胞免疫学指标的变化情况和接种后不良反应的发生率。结果观察300人次的接种，未发现任何不良反应。TB-PPD试验阴性组免疫前后淋巴细胞、Th细胞（CD4）、Ts细胞（CIX）、T细胞数均比免疫前显著增加，差异有显著的统计学意义。90％的TB-PPD试验阴性者细胞数的增长≥2个标准差，增长率92％～96％。TB-PPD试验阳性者免疫前后淋巴细胞数、Th细胞数均比接种疫苗前增加，差异有显著的统计学意义。TB-PPD试验阳性组免疫前后呈现出良好的双向免疫调节功能，淋巴细胞数、Th细胞数的增长率近70％，且增长幅度在1个标准差左右。结论对TB-PPD试验阴性或阳性者进行母牛分枝杆菌疫苗接种，均显示了较好的安全性和细胞免疫学效果，因此探讨用母牛分枝杆菌疫苗预防结核病，尤其是用于大龄儿童及青少年免疫预防有非常积极的意义。
Objective Safety and immunological effect of Mycobacterium vaccae for injection on tuberculosis prevention was evaluated in older non-tuberculosis children. Methods Healthy children （5- 9 years old） were divided into PPD positive group and PPD negative group. Each child in two groups was received 3 doses Mycobacterium vaceae for injection at 2 weeks interval. Blood samples were collected before vaccination and 1 month later after third injection. Lymphocyte, Th cells, Ts cells and T Iymphocyte were counted by FCM, and adverse reactions of vaccination were inspected. Results No any adverse reaction was observed during vaccination. The number of Lymphocyte, The cells, Ts ceils and T lymphocyte were significantly increased in PPD negative group （P 〈0.05. 90 percent of cell counts increase was above 2 SD with 92 % - 96 96 increase rate. The number of Lymphocyte, Th cells were significantly increased in PPD positive group （P 〈 0.05 with nearly 70 % increase rate. Conclusions The results showed that Mycobacterium vaccae vaccination is safe and effective on im- proving cellular immune function in PPD negative and PPD positive children, and suggested that Mycobacterium vaccae for injection is a valuable candidate vaccine for tuberculosis prevention in older children, which could replace BCG re-inoculation.
出处
《中国计划免疫》
2006年第6期500-503,共4页
Chinese Journal of Vaccines and Immunization
关键词
母牛分枝杆菌疫苗
预防接种
细胞免疫学效果
安全性
Mycobacterium vaccae for injection
Vaccination
Cellular immunological effect
Safety
