孩尔来福甲型肝炎灭活疫苗在儿童中应用的安全性和免疫原性观察

Study on Safety and Immunogenicity of Healive Inactivated Hepatitis A Vaccine Used among Children

为探讨孩尔来福 (Healive)甲型肝炎 (甲肝 )灭活疫苗在儿童中应用的安全性和免疫原性 ,选择 2～ 15岁抗甲肝病毒抗体 (抗 HAV)阴性健康易感儿童 91名作为接种对象 ,采用 0、6个月程序接种Healive甲肝灭活疫苗 2 5 0U/剂 ,观察免疫后的局部和全身不良反应 ,并于全程免疫后 1个月检测抗 HAV阳转率和抗体几何平均滴度 (GMT)。结果显示 :91名观察对象在接种第 1针和第 2针后均未见严重不良反应 ,仅在 8～ 72h出现轻微的一过性局部和全身轻度发热反应。全程免疫后 1个月抗 HAV阳转率为 10 0 % ,抗体GMT为 14 4 0 7mIU/ml。表明Healive甲肝灭活疫苗在儿童中应用具有良好的安全性和免疫原性 ,采用 0、6个月免疫程序可获得高滴度抗体。

To study the safety and immunogenicity of the Healive inactivated hepatitis A vaccine (HepAV) used among children 91 HAV antibody negative susceptible healthy children aged 2 to 15 were selected and vaccinated 250u/dose following the 0,6 months schedule The local and the systemic adverse effects were observed after vaccination,and the seroconvertion rate and geometric mean titers (GMT) of HAV antibodies were tested one month after full dose vaccination The results showed there were no severe adverse events occurred after the 1st and 2nd dose HepAV vaccination,only some slight and temporary local and systemic reactions 8～72 hs after vaccination The seroconvertion rate of HAV antibody was 100% one month after full dose vaccination,while the anti-HAV GMT was 14407mIU/ml It was concluded that the Healive inactivated HepAV has satisfactory safety and immunogenictity used among children High titer antibody can be attained following 0,6 months schedule