国产冻干水痘减毒活疫苗在印度的安全性及免疫原性分析  

Safety and immunogenicity of freeze-dried live attenuated varicella vaccine in India

作　　者：朱昌林 赵珍谊 陶航 徐娜 吴劲昌 

机构地区：[1]长春百克生物科技股份公司,吉林长春130012

出　　处：《中国生物制品学杂志》2015年第7期711-714,共4页Chinese Journal of Biologicals

摘　　要：目的观察国产冻干水痘减毒活疫苗在印度的安全性及免疫原性。方法采用单盲、平行、随机（1∶1）、对照的方法,在印度选择104名1-12岁无水痘病史、水痘疫苗接种史及接种禁忌的健康儿童,按照免疫程序,接种国产冻干水痘减毒活疫苗,并以水痘减毒活疫苗Varilrix誖作为对照疫苗,接种疫苗后30 min、0-6 d观察受试者局部和全身反应,采集受试者免疫前及免疫后42-47 d双份静脉血样,分离血清,采用膜抗原荧光抗体（fluorescent antibody to membrane antigen,FAMA）法检测血清中抗水痘-带状疱疹病毒（varicella-zoster virus,VZV）抗体水平,并计算抗体几何平均滴度（GMT）。结果实验组和对照组各52名（100%）受试者全程接种了相应的水痘疫苗,接种疫苗后30 min及0-6 d,均未见严重的局部副反应和全身不良反应,也未见疫苗接种者的密切接触者出现疫苗相关疾病;实验组和对照组免疫后血清抗体阳转率分别为92.31%和80.77%,差异无统计学意义（P〉0.05）;实验组和对照组免疫后血清抗体GMT分别为58.30和52.40,GMT增长倍数分别为6.21和5.36,两组免疫前及免疫后血清抗体GMT差异无统计学意义（P〉0.05）。结论国产冻干水痘减毒活疫苗在印度1-12岁儿童中接种,具有良好的安全性和免疫原性。Objective To observe the safety and immunogenicity of a domestic freeze-dried live attenuated varicella vaccine in India. Methods A total of 104 healthy children at ages of 1 - 12 years, without history of chicken pox,vaccination history of varicella vaccine or contraindication of vaccination, were selected in India for a single-blind, parallel and random（1 ∶ 1） trial. The children were vaccinated with domestic freeze-dried live attenuated varicella vaccine according to the immune schedule, using a vaccine（Varilrix誖）manufactured by Glaxo Smith Kline（GSK）as control, and observed for local and systemic reactions 30 min and 0 - 6 d after vaccination, of whom the serum samples before and 42 -47 d after immunization were collected in duplicated, and determined for antibody level against varicella zoster virus（VZV）with fluorescent antibody to membrane antigen（FAMA）, based on which the GMT was calculated. Results Fiftytwo subjects in trial and control groups received a complete series of immunization with varicella vaccine separately. No severe local or systemic adverse reactions or vaccine-associated diseases were observed 30 min or 0 - 6 d after immunization. The serum antibody positive conversion rates in trial and control groups were 92. 31% and 80. 77%respectively, which showed no significant difference（P〉0. 05）. The GMTs of serum antibodies after immunization in trial and control groups were 58. 30 and 52. 40, which increased by 6. 21 and 5. 36 folds, respectively, and showed no significant difference（P〉0. 05）. Conclusion The domestic freeze-dried live attenuated varicella vaccine showed good safety and immunogenicity in the children at ages of 1 - 12 years in India.

关 键 词：冻干水痘减毒活疫苗 安全性 免疫原性 

分 类 号：R373.24[医药卫生—病原生物学] R392.33[医药卫生—基础医学]