规范化H_2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 H_2

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．

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.