成人和儿童接种国产甲型肝炎灭活疫苗的安全性与免疫原性的初步观察

Safety and Immunogenicity of a New Home-made Inactivated Hepatitis A Vaccine in Children and Adults

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。

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.