健康儿童国产和进口甲型肝炎灭活疫苗接种不良反应和免疫持久性比较研究

Study on Adverse Reaction and Immune Persistence after Immunization of Domestic and Imported Hepatitis A Inactivated Vaccines among Healthy Children

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 This study aimed to investigate the safety and immune persistence of domestic and imported hepatitis A inactivated vaccines. Methods 325 healthy children who received immunization services in Baoji Maternal and Child Healthcare Hospital from January to March, 2009 were chose and di- vided into domestic-vaccine group （178） and imported-vaccine group （147） for the observation of ad- verse reaction within 48 hours after immunization and the detection of hepatitis A IgG antibody at 1 month and 1, 3 and 5 years after immunization. Results The adverse reactions caused by domestic and impor- ted vaccines were all common and mild with a 3.9% and 4. 1% of incidence rate for the first dose, re- spectively, and all 3.4% for the second dose. There was no significant difference in incidence rate for each dose between two groups. Antibody positive rate and geometric mean concentration （GMC） at 1 month after immunization, respectively, were 74. 2% and 382.3mlU/ml in domestic group, and 92. 5% and 421.6mlU/ml in imported group, with significant differences in positive rate or GMC between two groups. Antibody positive rate and GMC at 1 year after immunization, respectively, were 100% and 573.6mlU/ml in domestic group, and 100% and 442.3 mIU/ml in imported group; at 3 years, 100% and 524. 9 mlU/ml in domestic group, and 100% and 367.3mlU/mlin imported group; and at 5 years, 98.5% and 469.5 mlU/ml in domestic group, and 99.2% and 319.0 mlU/ml in imported group. There were no significant differences in positive rate but in GMC at 1, 3 or 5 years after immunization. Conclusions The domestic and imported hepatic A vaccines were all safe and effective for children. The early immune efficacy of imported vaccine was higher than that of domestic vaccine. The antibody levels of domestic vaccine at 1-5 years afterimmunization were higher than that of imported vaccine