冻干甲肝减毒活疫苗安全性及免疫原性观察  

Observation on Safety and Immunogenicity of Freeze-dried Live Attenuated Hepatitis A Vaccine

作　　者：陈万庚 周爱庆[1] 何飞[1] 方娟[1] 马永法[1] 马福宝[2] 康国栋[2] 叶珣[2] 

机构地区：[1]江苏省盐城市盐都区疾病预防控制中心,江苏盐城224002 [2]江苏省疾病预防控制中心

出　　处：《实用预防医学》2012年第3期359-361,共3页Practical Preventive Medicine

基　　金：盐城市医学科技发展计划项目(编号:YK2011050)

摘　　要：目的评价国产冻干甲肝减毒活疫苗的安全性和免疫原性。方法选择部分18~24月龄健康儿童接种1剂甲肝减毒活疫苗,使用统一的＂疫苗接种日记卡＂观察记录疫苗接种后副反应,于免后28 d采集血清检测抗-HAVIgG。结果共接种18~24月龄健康儿童354人,14 d内副反应发生率10.73%,发热反应发生率为7.06%,未观察到严重异常反应;检测有效血清标本333份,免后28 d抗-HAV阳性率为92.79%,抗-HAV GMT为14.60 mIU/ml。结论国产冻干甲肝减毒活疫苗具有良好的安全性和免疫原性。Objective To evaluate the safety and immunogenicity of domestic lyophilized live attenuated hepatitis A（HA） vaccine. Methods Some healthy children at 18～24 months of age were selected to inoculate with a single dose of freeze-dried live attenuated HA vaccine,and the adverse reactions after inoculation were monitored and recorded using a uniform ＂vaccination diary card＂.The serum samples were collected 28 days poat-vaccination for detection of IgG anti-HAV. Results A total of 354 healthy children aged 18 to 24 months were inoculated with freeze-dried live attenuated HA vaccine.The incidence rates of adverse reactions and febrile response within 14 days were 10.73% and 7.06%,respectively.No severe abnormal responses were observed.333 serum samples were detected effectively.28 days after vaccination,the positive rate of anti-HAV was 92.79% and GMT of anti-HAV was 14.60 mIU/ml. Conclusions Domestic freeze-dried live attenuated HA vaccine shows a good safety and immunogenicity profile.

关 键 词：甲型肝炎 减毒活疫苗 安全性 免疫原性 

分 类 号：R512.61[医药卫生—内科学]