甲型肝炎灭活疫苗和减毒活疫苗在青壮年人群中的免疫原性和安全性研究  

Immunogenicity and safety of inactivated and live attenuated hepatitis A vaccines in Chinese young adults

作　　者：廖征[1] 刘学恩[2] 王旭[3] 陈海婴[1] 刘研[3] 冯小武[1] 熊昌辉[1] 文海蓉[1] 彭时辉[1] 张艳霞[1] 吴俊燏[3] 庄辉[2] 

机构地区：[1]南昌市疾病预防控制中心,江西南昌330038 [2]北京大学医学部基础医学院病原生物学系和感染病中心,北京100191 [3]北京科兴生物制品有限公司,北京100085

出　　处：《中国病毒病杂志》2012年第4期310-314,共5页Chinese Journal of Viral Diseases

摘　　要：目的比较甲型肝炎(甲肝)灭活疫苗和减毒活疫苗在青壮年人群中的免疫原性和安全性。方法免疫前甲肝抗体呈阴性的16～25岁大学生,被随机分为3组:A组接种1剂500U/剂甲肝灭活疫苗;B组接种1剂6.50lg CCID50/剂甲肝减毒活疫苗;C组接种2剂(0、6月程序)500U/剂甲肝灭活疫苗。接种后进行30min即时反应和72h反应的随访观察。受试者于第0、1.5(A和B组)或7月(C组)、12月采血,检测抗甲肝病毒抗体(抗-HAV)。抗-HAV滴度≥20IU/L为阳转。结果在接种后第12个月时,A、B、C组抗-HAV阳转率分别为88.4%、82.0%和100.0%,抗体几何平均滴度(GMC)分别为154.20(95%CI:109.44～217.27)、89.99(95%CI:59.60～135.89)和1 637.88(95%CI:1 326.42～2 022.47)IU/L。在安全性方面,不论1剂或2剂接种,甲肝灭活疫苗和减毒活疫苗均表现出良好耐受性;不良反应的发生率为2.9%,均为轻度,各组间差异无统计学意义。结论不论1剂或2剂接种,甲肝灭活疫苗和减毒活疫苗在青壮年人群中表现出良好免疫原性和安全性。Objective To compare the immunogenicity and safety of inactivated and live attenuated hepatitis A vaccines in Chinese young adults.Methods Healthy undergraduate students aged 16 to 25 years with anti-HAV negative were randomly divided into three groups.Group A and B were administrated with one-dose inactivated and live attenuated hepatitis A vaccines,respectively;Group C was immunized with two doses of inactivated vaccine at months 0 and 6.Blood samples were collected at months 1,1.5（from group A and B） or 7（from group C）,and 12（from all groups） to detect the levels of anti-HAV.Vaccine safety was observed during the first 30 minutes at the injection-site and systemic side-effects were recorded for three consecutive days after vaccination.Results The anti-HAV seroconversion rates in groups A,B and C were 88.4%,82.0% and 100.0%,respectively;and GMC were 154.20 IU/L（95%CI：109.44-217.27 IU/L）,89.99 IU/L（95%CI：59.60-135.89 IU/L） and 1 637.88 IU/L（95%CI：1 326.42-2 022.47 IU/L）,respectively.Both inactivated and live attenuated vaccines at different regimens were well tolerated in young adults.The total incidence of adverse reactions was 2.9%.All side effects were mild and there were no significant differences among these three groups.Conclusions Both inactivated and live attenuated hepatitis A vaccines are highly immunogenic with safety profiles in young adults in China.

关 键 词：病毒性肝炎 甲型 灭活疫苗 减毒活疫苗 免疫原性 安全性 

分 类 号：R186[医药卫生—流行病学]