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目的观察规范化甲型肝炎减毒活疫苗LA-1株的免疫原性和抗体动态变化。方法在广西柳城县选择3105名经甲肝抗体检测为阴性的易感儿童,以随机双盲安慰剂对照法分成疫苗组(1624名)和对照组(1481名),疫苗滴度106.75TCID50;疫苗组于免疫后3、6、12、24、36月份分别进行定人和定群观察;免后3年对两组进行横断面调查甲肝抗体。结果1剂疫苗免后抗体高峰出现于3~6个月,抗体阳转率峰值达到91.4%,GMT为106.31mIU/ml;3年后,甲肝抗体阳性率并未随免疫后年限延长而明显下降,疫苗使接种儿童抗体阳性率达到非接种儿童的3.8倍。结论1剂国产规范化甲肝减毒活疫苗(LA-1株)可诱导高水平且较持久的免疫。
Objective To observe the immunogenicity and antibody changes of normalized attenuated live attenuated hepatitis A vaccine strain LA-1. Methods A total of 3105 susceptible children who were negative for hepatitis A antibody were selected in Liucheng County, Guangxi. The vaccine was divided into vaccine group (1624) and control group (1481) by random double-blind placebo control. The vaccine titer was 106.75TCID50. Groups were observed at 3, 6, 12, 24 and 36 months after immunization, respectively. The cross-sectional investigation of hepatitis A antibody was performed in the two groups after 3 years. Results The highest antibody-free antibody peak appeared in 3 to 6 months, the peak of antibody positive rate reached 91.4% and the GMT was 106.31mIU / ml. After 3 years, the positive rate of anti-HBeAg did not increase with the duration of immunization But significantly decreased, the vaccination vaccination children antibody positive rate of non-vaccinated children 3.8 times. Conclusion One dose of live attenuated live attenuated hepatitis A vaccine (LA-1 strain) can induce high level and more lasting immunity.