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规范化H2株甲型肝炎减毒活疫苗安全性及免疫原性研究

Study on Safety and Immunogenicity of the Live Attenuated Standardized Hepatitis A Vaccine Strain H2

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【作者】 马景臣张勇韩常全张英林刘洪斌张玉伟刘玉忠邢占春汪萱怡徐志一

【Author】 MA Jing chen; ZHANG Yong; HAN Chang-quan et al.( Epidemic Prevention Station of Zhengding County, Hebei Province, Zhengding County 050800, China.)

【机构】 河北省正定县卫生防疫站!正定县050800河北医科大学河北省卫生防疫站0508

【摘要】 为考察提高满度后的规范化H2株甲型肝炎(甲肝)减毒活疫苗(滴度为107.0TCID50/ml)的安全性和免疫原性,在正定县的3个乡24个行政村调查了1~7岁儿童,经询问调查和血清检测.共筛出3515名儿童为观察对象,分为疫苗组和对照组.疫苗组在接种疫苗后观察临床反应并进行血清学随访.结果表明,该疫苗接种后3天内发热率与对照组无明显差异;免疫后2~3个月抗体阳转率和几何平均浓度达高峰,分别为94.9%~92.2%、131.3mIU/ml~126.2mIU/ml,免疫后6~12个月抗体阳性率和滴度呈平稳下降趋势。从而证实规范化H2株甲肝减毒活疫苗具有良好的安全性和免疫原性.

【Abstract】 For evaluating the safety and immunogenicity of the live attenuatedstandardized hepatitis A (HA) vaccine strain H, (titer lO’o TCID50/ml), we chose 3 515children aged 1 -7 from 24 administrative villages of 3 towns in Zhengding County forstudy. These children had no history of liver diseases, no HAV vaccination and noimmunoglobulin injection in the recent six months and also were anti-HAV seronegative.They were divided into two groups, one for HAV vaccination, the other for control. Theclinical reactions and responsive serum antibody were followed up. The results showed thatthe feverish rate of vaccinated group within 3 days of vaccination was the same as that ofthe control group, the HA antibody positive seroconversion rate and the peak geometricmean concentration (GMC) after 2 - 3 months of vaccination were 94.9% ~ 92.2% and 131 .3mIU/ml ~ 126.2mIU/ml respectively. 6 ~ 12 months after immunization, the antibody posi-tive rate and antibody titer showed a smooth decreasing. The safety and a goodirnmunogenicity of the live attenuated standardized HA vaccine strain H, has beendemonstrated.

【基金】 国家“九五”攻关课题!03-03-01
  • 【文献出处】 中国计划免疫 ,CHINESE JOURNAL OF VACCINES AND IMMUNIZATION , 编辑部邮箱 ,1999年05期
  • 【分类号】R186
  • 【被引频次】13
  • 【下载频次】73
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