水痘减毒活疫苗的研制及免疫效果观察  

Studies on preparation and immunological efficacy of a live attenuated varicella vaccine

作　　者：陈志慧[1] 王宪明[1] 殷月娣[1] 王亮[1] 沈谊清[1] 徐建军[1] 吕国贞[2] 王树巧[3] 

机构地区：[1]上海生物制品研究所生技中心,200052 [2]上海生物制品研究所质保部,200052 [3]上海生物制品研究所流行病研究室,200052

出　　处：《国际生物制品学杂志》2006年第3期97-100,共4页International Journal of Biologicals

摘　　要：目的观察由日本大阪大学微生物病研究会（BIKEN）提供的Oka株水痘病毒研制的水痘减毒活疫苗的稳定性、安全性和免疫原性。方法按WHO规程要求建立主种子批和工作种子批，检测病毒的生物学特性和疫苗稳定性。在上海市、江苏省进行临床试验，5批疫苗共接种468名2～6岁易感儿童，观察接种者的不良反应，测定抗体阳转率及抗体几何平均滴度。结果Oka株水痘病毒在MRC-5细胞上传10代，其生物学特性相似，疫苗在2～8℃保存2年，病毒滴度下降0．3～0．51gPFU／剂。易感儿童接种后皮疹发生率为0．21％；低、中、高发热反应率分别为21．79％、10．68％、0．64％。抗体阳转率平均为92．03％。结论研制的水痘减毒活疫苗的质量与国外同类产品相似，在易感儿童中的安全性与免疫原性良好，宜推广应用。Objective To observe the stability,safety,and immunogenicity of the live attenuated Oka varicella vaccine produced by Shanghai Institute of Biological Products （SIBP）. The Oka strain was provided by the Research Foundation for Microbial Diseases in Osaka University（BIKEN）. Methods Master and working seed lots were established according to the WHO Requirements for Biologics. Biological characteristics of the virus and stability of the vaccine were studied. Clinical trials were carried out in Shanghai and Jiangsu Province. Four hundred and sixty-eight susceptible children 2-6 years of age received 5 lots of varicella vaccine. After vaccination, the incidence of adverse events, seroconversion rate, and geometric mean titer of varicella antibody were determined. Results The Oka strain underwent 10 passages（from 28th to 38th） in MRC-5 cells. The biological characteristics of master and working seed lots were the same. After the vaccine was stored at 2-8℃ for 2 years,virus titer decreased by 0. 3-0.5 lg PFU/dose. The incidence of rash was 0. 21% in immunized children. The rates of low-grade, moderate,and high fever were 21.79%, 10. 68% ,and 0. 64%, respectively. Seroconversion rate was 92.03%. Conclusion These findings clearly demonstrate that the live attenuated varicella vaccine of SIBP has the same quality,safety,and immunogenicity as imported vaccines and may be suitable for wide use.

关 键 词：疱疹病毒3型 人 水痘疫苗 疫苗 减毒 稳定性 免疫效果 

分 类 号：R392[医药卫生—免疫学]