国产冻干水痘减毒活疫苗的安全性和免疫原性研究  

Study on Safety and Immunogenicity of Lyophilized Live Atlenuated Domestic Varicella Vaccine

作　　者：王树巧[1] 李长贵[2] 李燕婷[3] 袁家麟[4] 陶红 王志军 吕国贞[1] 王宪明[1] 陈志慧[1] 谢广中[1] 

机构地区：[1]上海生物制品研究所,上海200052 [2]中国药品生物制品检定所,北京100050 [3]上海市疾病预防控制中心,上海200031 [4]上海市卢湾区疾病预防控制中心,上海200025 [5]江苏省卫生防疫站,南京210009 [6]扬州市广陵区卫生防疫站,江苏扬州225000

出　　处：《中国计划免疫》2000年第6期334-347,共14页Chinese Journal of Vaccines and Immunization

摘　　要：1998年 9月～ 1999年 12月在上海市卢湾区和扬州市广陵区 ,对我国用Oka株和日本工艺生产的冻干水痘减毒活疫苗的安全性和免疫原性进行了系统观察 ,并以日本生产的VZ 0 5疫苗和安慰剂作对照。用 5批国产疫苗接种 46 8人 ,发生低热反应 10 2人 (2 1 79% ) ,中热反应 5 0人 (10 6 8% ) ,强热反应 3人 (0 6 4% ) ;日本VZ -0 5疫苗接种 5 9人 ,发生低热反应 6人 (10 17% ) ,无中、强反应。用 5批国产疫苗接种免疫前抗体阴性者 2 5 1人 ,抗体阳转 2 31人 ,平均阳转率为 92 0 3 % (84 0 0 %～ 98 0 0 % ) ,抗体几何平均滴度 (GMT)为 1:5 5 8 46～ 1:112 9 47;而日本VZ 0 5疫苗的阳转率为 89 80 % ,GMT为 1:112 6 10。用 5批国产疫苗 (1剂 )接种免疫前抗体阳性者 ,接种后抗体滴度明显上升 ,GMT比免疫前提高 3 34倍。此结果表明 ,国产疫苗反应轻微 ,安全性好 ,免疫原性亦好。The varicella zoster virus Oka strain and the technology of production were introduced from Japan The safety and immunogenicity of the lyophilized live attenuated domestic varicella vaccine of Oka strain was observed in Luwan District of Shanghai and Guangling District of Yangzhou in Sept 1998-Dec 1999 The vaccine strain VZ-05 produced in Japan and placebo were set as controls 468 persons were inoculated using five batches of domestic live attenuated varicella vaccine, 102(21 79%) had low fever,50(10 68%) had moderate fever and 3(0 64%) had high fever There were 59 persons inoculated with Japanese varicella vaccine VZ 05 strain,6 of them (10 17%) showed low fever,but none of them had moderate or high fever 231 out of 251 persons who were varicella antibody negative prior Oka vaccination became antibody positive,the seroconversion rate was 92 03% (84 00%～98 00%), the GMT was 1:558 64～1:1,129 47,but that of the Japan VZ 05 vaccine strain were 89 80% and 1:1,126 10 respectively People who were seronegative before Oka immunization, when vaccinated (1dose),the antibody titer rose significantly,the GMT ascended 3 34 times These results showed a good safety and immunogenicity of the live attenuated domestic varicella vaccine,also,there is no virus transmission from vaccines to the close contacts

关 键 词：冻干水痘减毒活疫苗 安全性 抗体阳转率 水痘 

分 类 号：R511.501[医药卫生—内科学]