国产甲型肝炎灭活疫苗在低龄儿童中应用的安全性和免疫原性研究

Study on the Safety and Immunogenicity of China Made Inactivated Hepatitis A Vaccine in HAV Susceptive Children

目的 探讨国产甲型肝炎灭活疫苗在低龄儿童(1～4岁)中应用的安全性和免疫原性。方法 选1～4岁易感健康儿童63名,随机分为两组,按0,3和0,6程序接种国产甲肝灭活疫苗500U/剂,观察免疫后的局部和全身反应。并检测初免后及全程免疫后的抗-HAV阳转率和抗体GMT。结果 初免和加强免疫后有轻微的一过性局部和全身反应,未见肝功异常。初免后1、3、6个月抗体阳转率分别为85.7％、88.5％和83.8％;抗体GMT分别为182mU/ml、225mu/ml和252mU/ml;0,3和0,6程序全程免疫后1个月抗体阳转率均为100％;抗体GMT分别为2718mU/ml和4683mU/ml。结论 国产甲肝灭活疫苗在低龄儿童中应用具有良好的安全性和免疫原性;接种两剂可获高滴度甲肝抗体;0,6程序优于0,3程序。

Objective To investigate the safety and immunogenicity of a domestic inactivated hepatitis A vaccine when applied to young children (1-4 years old) .Methods sixty - three susceptible healthy children whose age range from 1 to 4 were divided into two groups at random, and inoculated with 500u/dose according to the 0, 3 months schedule or 0, 6 months schedule.The local and the systemic side effects were observed after vaccination, the seroconversion rate and geometric mean tilers (GMT) of hepatitis A virus antibodies were evaluated after primary immunization and the booster as well. Results The local and systemic effects reactions after the primary immunization and the booster immunization are slight and temporary. Abnormal liver .function was not observed. The seroconversion rates of HAV antibody were 85.7%, 88.5% and 83.8% corresponding to the 1, 3, 6 months after the primary immunization, and its GMTs were 182mIU/ml, 243mIU/ml, 280mIU/ml res pectively.Both seroconversion rate for0, 3 months schedule and 0, 6 momths schedule were 100% 1 month after booster, while the anti - HAV GMTs for which were 2718mIU/ml and 4683mIU/ml respectively. Conclusion The domestic inactivated hepatitis A vaccine has satisfactory safety and immunogenicity when applied to young children; 0, 6 months schedule was better than 0, 3 months schedule.