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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 domestic hepatitis A inactivated vaccine in young children (1 ~ 4 years old). Methods Sixty-three susceptible and healthy children aged 1 to 4 years were randomly divided into two groups. The inactivated hepatitis A vaccine (500U / dose) was administered according to 0, 3, and 0, 6 procedures. Local and systemic reactions after immunization were observed. Anti-HAV positive rate and antibody GMT after initial immunization and after immunization were detected. Results After initial and intensive immunization, there was a slight transient local and systemic reaction, no abnormal liver function. Antibody positive conversion rates were 85.7%, 88.5% and 83.8% respectively at 1, 3, and 6 months after primary immunization. Antibody GMT was 182mU / ml, 225mu / ml and 252mU / ml respectively. The antibody positive rate was 100% at 1 month after immunization. The antibody GMT was 2718mU / ml and 4683mU / ml, respectively. Conclusions Domestic hepatitis A inactivated vaccine has good safety and immunogenicity in young children. High doses of hepatitis A antibody can be obtained after inoculation of two doses. 0 and 6 are better than 0 and 3.