摘要
目的比较国产甲型肝炎减毒活疫苗的安全性及免疫原性。方法选择出生后未接种过甲型肝炎疫苗的18～24月龄儿童,按照随机、对照的原则分为实验组和对照组,每组接种不同的国产甲型肝炎减毒活疫苗。观察接种后30 d局部及全身反应;免疫后30 d采血,分离血清,检测抗体滴度。结果 306名受试者共观察到109例不良反应,实验组及对照组不良反应发生率分别为34. 4%和36. 8%,差异无统计学意义(P> 0. 05);实验组及对照组免疫后甲型肝炎病毒(hepatitis A virus,HAV)抗体阳性率分别为99. 3%和99. 4%,抗体几何平均滴度(GMT)分别为211. 3和224. 6 mIU/mL,差异均无统计学意义(P> 0. 05)。结论两种国产甲型肝炎减毒活疫苗均具有良好的安全性及免疫原性。
Objective To compare the safety and immunogenicity of two domestic live attenuated hepatitis A vaccines.Methods A randomized and blind control study was performed on children at ages of 18 ~ 24 months. The children were randomly divided into trial and control groups and inoculated with live attenuated hepatitis A vaccines from two manufacturers respectively. Local and systemic reactions were observed within 30 d after vaccination. Blood samples were collected 30 d after vaccination and determined for antibody titer. Results A total of 109 cases of adverse reactions were observed in 306 children vaccinated. The incidences of adverse reactions in trial and control groups were 34. 4% and 36. 8% respectively,which showed no significant difference(P > 0. 05). However,the hepatitis A virus(HAV)antibody positive rates in trial and control groups were 99. 3% and 99. 4%,while the GMTs were 211. 3 and 224. 6 mIU/mL,respectively,which showed no significant difference(P > 0. 05). Conclusion Both the domestic live attenuated hepatitis A vaccines showed good safety and immunogenicity.
作者
郭雪
陈海平
姜崴
石煊雯
肖艳慧
丁丽丽
赵淑洁
罗林云
GUO Xue;CHEN Hai-ping;JIANG Wei;SHI Xuan-wen;XIAO Yan-hui;DING Li-li;ZHAO Shu-jie;LUO Lin-yun(Changchun Institute of Biological Products Co., Ltd., Changchun 130012, Jilin Province, China)
出处
《中国生物制品学杂志》
CAS
CSCD
2019年第5期508-511,共4页
Chinese Journal of Biologicals
关键词
甲型肝炎
减毒活疫苗
安全性
免疫原性
Hepatitis A
Live attenuated vaccine
Safety
Immunogenicity
