【摘要】 为了评价国产甲型肝炎 (甲肝 )灭活疫苗在儿童中应用的安全性、免疫原性和免疫程序 ,在河北省某地山区农村筛选 5～ 15岁的甲肝易感儿童 2 75人 ,以村为单位 ,随机分为 4组 ,分别接种 10 0 0U/剂和 5 0 0U/剂 (0、3个月和0、6个月程序 ) ,观察初种和加强免疫后局部反应和全身反应 ,检测免疫后 1、3、4、6、7个月的血清抗甲肝病毒抗体(抗 -HAV)阳转率和滴度。结果显示 :国产甲肝灭活疫苗无严重的局部及全身反应 ,10 0 0U/剂和 5 0 0U/剂初免后1个月抗 -HAV阳转率分别为 93 8%和 90 6 % ,抗体滴度分别为 174mIU/ml和 14 6mIU/ml;全程免疫后 1个月各组抗体阳转率均为 10 0 0 % ,10 0 0U组和 5 0 0U组抗 -HAV滴度分别为 75 4 0mIU/ml、4 5 35mIU/ml;5 0 0U组 0、6个月和 0、3个月程序免疫后抗 -HAV滴度分别为 4 5 35mIU/ml和 32 6 9mIU/ml,两组比较差异有极显著的统计学意义。表明国产甲肝灭活疫苗在儿童中应用是安全、有效的 ,5 0 0U/剂适用于儿童 ,免疫程序以 0、6个月为佳更多还原

【Abstract】 In order to evaluate the immunogenicity,safety and vaccination schedule of a new inactivated hepatitis A(HA)vaccine,275healthy children in mountain area villages of Hebei Province aged 5?15,negative both for HBsAg and anti-HAV antibody were choosen and were randomly divided into 4 groups by village They were given 1,000 units(U)/dose and 500units(U)/dose of vaccine by 0,3 and 0,6 month schedules The local and systemic site effects were examined 30 min after vaccination and within 8h, 24h, 48h,72h, of vaccination respectively The seroconversion rate and the geometric mean titer(GMT)of anti-HA antibody were tested at months 1,3,4,6,7 The results showed that the local and systemic side effects of the new inactivated HA vaccine after first dose administration were 11 76% and 12 23% among children given 1,000U and 500U respectively One month after the first dose,the positive seroconversion rates and GMTs of 1,000U and 500U groups were 93 8%,90 6% and 174mIU/ml,146mIU/ml respectively One month after the second dose of vaccine,the positive seroconversion rates of all 4 groups were 100%,and the GMT raised to 7,540mIU/ml in 1,000U group and 4,535mIU/ml in 500U group The GMT in 500U group with 0,6 month schedule was more higher than that of 0,3 month schedule,4,535 mIU/ml versus 3,269mIU/ml,the difference was statistically significant We concluded that the new inactivated hepatitis A vaccine has good immunogenicity and safety, the 500 units/dose with 0,6 month schedule is better than 0,3 month schedule for childrena更多还原