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目的探讨国产和进口甲型肝炎(甲肝)灭活疫苗在健康儿童中接种的安全性和免疫效果。方法选取2009年1~3月宝鸡市妇幼保健院预防接种服务的健康儿童325名,分为国产疫苗组(178名)和进口疫苗组(147名),观察接种疫苗后48小时内不良反应,检测完成接种后1月、1年、3年和5年的甲肝IgG抗体。结果国产和进口疫苗接种后不良反应均为一般反应,第1剂发生率分别为3.9%和4.1%,第2剂发生率均为3.4%,各剂次两组之间,二者无统计学差异;完成接种后1月甲肝抗体阳性率分别为74.2%和92.5%,抗体几何平均浓度(Geometric Mean Concentration,GMC)分别382.3m IU/ml、421.6m IU/ml,两组阳性率或GMC有统计学差异。接种后1年两组抗体阳性率均为100%,GMC分别573.6m IU/ml和442.3m IU/ml;接种后3年两组抗体阳性率均为100%,GMC分别524.9m IU/ml和367.3m IU/ml;接种后5年两组抗体阳性率分别为98.5%和99.2%,GMC分别469.5m IU/ml和319.0m IU/ml;接种后各年两组抗体阳性率无统计学差异,GMC有统计学差异。结论国产和进口甲肝灭活疫苗的安全性和效果均较好,进口疫苗早期的免疫效果优于国产疫苗;接种1~5年国产疫苗的抗体水平较进口疫苗高。
Objective To investigate the safety and immunization effects of domestic and imported hepatitis A (Hepatitis A) inactivated vaccines in healthy children. Methods A total of 325 healthy children were enrolled in the vaccination service of Maternal and Child Health Hospital of Baoji City from January to March in 2009. The patients were divided into domestic vaccine group (178) and imported vaccine group (147). Adverse reactions within 48 hours after vaccination were observed, Hepatitis A IgG antibodies at 1 month, 1 year, 3 years and 5 years after completion of inoculation were tested. Results Domestic and imported adverse reactions after vaccination were general reactions, the incidence of the first agent was 3.9% and 4.1% respectively, and the second agent was 3.4%. There was no statistic difference between the two groups The positive rates of hepatitis A antibody in January were 74.2% and 92.5%, respectively. The Geometric Mean Concentration (GMC) was 382.3m IU / ml and 421.6m IU / ml, respectively. The positive rate of GMC was Statistical differences. The antibody positive rates of the two groups were 100%, 573.6m IU / ml and 442.3m IU / ml respectively at 1 year after inoculation. The antibody positive rates of both groups were 100% and 524.9m IU / ml at 3 years after inoculation 367.3m IU / ml. After 5 years of inoculation, the antibody positive rates of the two groups were 98.5% and 99.2%, respectively. The GMCs were 469.5m IU / ml and 319.0m IU / ml respectively. There was no significant difference in antibody positive rate between the two groups , GMC have statistical difference. Conclusion The safety and efficacy of domestic and imported hepatitis A inactivated vaccines are better than those of imported vaccines. The immune effect of imported vaccines is better than domestic vaccines at the early stage. The antibody level of domestic vaccines vaccinated 1-5 years later is higher than that of imported vaccines.