国产甲型肝炎灭活疫苗的安全性与免疫原性初步观察

目的 评价国产甲型肝炎灭活疫苗的安全性和免疫原性。方法 对健康易感儿童1％名和成人206名随机分为4组，107名儿童(A组)和131名成人(B组)接种国产甲肝灭活疫苗，另69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640EIU／1．0ml。成人1440EIU／1．0ml，对照疫苗剂量儿童720EIU／1．0ml，成人1440EIU／1．0ml，均采用0、6程序。观察72小时内局部和全身反应及免后1、6、7月的免疫应答水平。结果 所有接种对象均未出现明显局部和全身副反应，亦未发现免后ALT升高。初免后一个月A组和B组抗体阳性率分别为94．8％和96．7％，几何平均滴度为758．6mIU／ml和3630．8mIU／ml。全程免疫后一个月4组抗体阳性率均为100％，A组和B组抗体几何平均滴度上升至10471．2mIU／ml和12302．7mIU／m1，略高于对照的C组和D组(分别为3090．3mIU／d和3388．4mIU／ml)。结论 国产甲肝灭活疫苗具有良好安全性和免疫原性。

Safety and immunogenicity of a new inactivated hepatitis A vaccine in children and adults

Objective To assess the safety and immunogenicity of a new inactivated hepatitis A vaccine in children and adults. Methods 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 640EIU/ 1.0ml and 1440EIU/1.0ml of home-made inactivated hepatitis A vaccine (Institute of Medical Biology, Chinese Academy of Medical Sciences), 69 children (group C) and 75 adults (group D) were given 720 EIU/ 1. 0ml and1440EIU/ 1.0ml of inactivated hepatitis A vaccine (SmithKline, Beecham Biologicals) by 0, 6 month schedule.The local and systemic side-effects were recorded the first 72 hours after each vaccination. Seroconversion rate and geometric mean titer (GMT) of antibody to hepatitis A were tested at months 1, 6 and 7 after first dose of vaccination. Results Local and systemic side effects were not observed in all participants within 3 days after first dose vaccination and no elevation of ALT was found. One month after first dose of vaccination, the seroconversion rates and GMTs of anti - HAV IgG were 94.8% and 96.7% as well as 758.6mIU/ ml and, 3630.8 mIU/ 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 ( 10471.2 mIU/ml and 12302.7 mIU/ml )were more higher than those in group C and D(3090.3 mIU/ml and 3388.4 mIU/ml) .Conclusion The home-made new inactivated hepatitis A vaccine was safe and highly immunogenic.