【摘要】 为了评价国产甲型肝炎 (甲肝 )灭活疫苗的安全性和免疫原性 ,将 176名健康易感儿童和 2 0 6名成人随机分为 4组 ,10 7名儿童 (A组 )和 131名成人 (B组 )接种国产甲肝灭活疫苗 ,另 6 9名儿童 (C组 )和 75名成人 (D组 )作为对照接种史克必成公司生产的甲肝灭活疫苗。国产疫苗剂量为儿童 6 4 0EU/1 0ml,成人 12 80EU/1 0ml;对照疫苗剂量儿童 72 0EIU/1 0ml,成人 14 4 0EIU/1 0ml,均采用 0、6个月免疫程序。观察 72h内局部和全身反应 ,免疫后 1、6、7个月的免疫应答水平。结果显示 :所有接种对象均未出现明显的局部和全身副反应 ,亦未发现免疫后丙氨酸氨基转移酶 (ALT)升高。初次免疫后 1个月 ,A组和B组抗体阳转率分别为 94 8%和 96 7% ,几何平均滴度(GMT)为 75 8 6mIU/ml和 36 30 8mIU/ml。全程免疫后 1个月 ,4个组抗体阳转率均为 10 0 % ,A组和B组抗体GMT升至 10 4 71 2mIU/ml和 12 30 2 7mIU/ml,略高于对照的C组和D组 (分别为 30 90 3mIU/ml和3388 4mIU/ml)。表明国产甲肝灭活疫苗具有良好安全性和免疫原性。更多还原

【Abstract】 To assess the safety and immunogenicity of a new home-made inactivated hepatitis A vaccine in children and adults,176 healthy children and 206 healthy adults with both HBsAg and hepatitis A IgG antibody negative selected from Mengshan County of Guangxi Zhuang Autonomous Region were randomly divided into 4 groups.107 children(group A)and 131 adults(group B)were received 640EU/1.0ml and 1,280EU/1.0ml of home-made inactivated hepatitis A vaccine(made by Institute of Medical Biology,Chinese Academy of Medical Sciences),69 children(group C)and 75 adults(group D)were given 720El- U/1.0ml and 1,440ElU/1.0ml of inactivated hepatitis A vaccine(SmithKline,Beecham Biologicals) all by 0,6 month schedule.The local and systemic site effects were recorded at first 72 hours after each vaccination.Seroconversion rate and geometric mean titer(GMT)of antibody to hepatictis A were tested at months 1,6 and 7 after first dose of vaccination.The results showed that the local and systemic site effects were not observed in all participants within 3 days after first dose vaccination and no elevation of ALT.One month after first dose of vaccination,the seroconversiton rates and GMTs of anti-HAV IgG were 94.8%,96.7% and 758.6mIU/ml,3,630.8mIU/ml in group A and B,respectively.One month after second dose of vaccination,the seroconversion rates of anti-HAV IgG of all 4 groups were 100%,the GMTs in group A and B(10,471.2mIU/ml and 12,302.7mIU/ml)was more higher than that in group C and D(3,090.3mIU/ml and 3,388.4mIU/ml).The home-made new inactivated hepatitis A vaccine is safe and highly immunogenic.更多还原