中华流行病学杂志
中華流行病學雜誌
중화류행병학잡지
CHINESE JOURNAL OF EPIDEMIOLOGY
2013年
1期
24-27
,共4页
甲型肝炎疫苗%安全性%免疫原性
甲型肝炎疫苗%安全性%免疫原性
갑형간염역묘%안전성%면역원성
Hepatitis A vaccine%Safety%Immunogenicity
目的 评价中国甲型肝炎(甲肝)减毒活疫苗(HepA-L)和甲肝灭活疫苗(HepA-Ⅰ)的安全性及免疫效果,为甲肝暴发疫情疫苗应急接种提供参考依据.方法 用美国雅培(Abbott)公司生产的抗甲肝病毒抗体(抗-HAV)试剂筛查未感染HAV的6～9岁儿童.将入选对象随机分为4组,分别接种国产HepA-L和HepA-I,以国产重组乙肝疫苗(酿酒酵母)(HepB-SCY)为阴性对照,GlaxoSmithKline Biologicals S.A.(GSK)生产的HepA-I为阳性对照,采取随机双盲方法观察接种疫苗后30 min及24、48、72 h的不良反应发生率.采用美国Abbott Laboratories生产的HAVAB 2.0试剂,利用微粒子酶免疫分析与电化学发光免疫测定法(MEIA)检测1、2、4周以及12个月的HAV-IgG抗体水平.结果 各组未发现严重不良反应,不良反应主要表现为发热、接种部位疼痛、硬结等.国产HepA-L和HepA-I组不良反应发生率分别为13.95％和15.25％,阳性对照组为16.80％,阴性对照组为25.62％,各组间差异无统计学意义.接种2周后,国产HepA-L和HepA-I抗体阳转率分别为85.00％和94.59％；接种后第4周,抗体阳转率达到100％；接种2、4、12周时试验组、阳性对照组HAV-IgG抗体水平高于阴性对照组；接种12个月后,国产HepA-I组甲肝抗体水平高于阳性对照组.结论 国产HepA-L和HepA-I以及进口HepA-I安全性良好,均具有较好的免疫效果.
目的 評價中國甲型肝炎(甲肝)減毒活疫苗(HepA-L)和甲肝滅活疫苗(HepA-Ⅰ)的安全性及免疫效果,為甲肝暴髮疫情疫苗應急接種提供參攷依據.方法 用美國雅培(Abbott)公司生產的抗甲肝病毒抗體(抗-HAV)試劑篩查未感染HAV的6～9歲兒童.將入選對象隨機分為4組,分彆接種國產HepA-L和HepA-I,以國產重組乙肝疫苗(釀酒酵母)(HepB-SCY)為陰性對照,GlaxoSmithKline Biologicals S.A.(GSK)生產的HepA-I為暘性對照,採取隨機雙盲方法觀察接種疫苗後30 min及24、48、72 h的不良反應髮生率.採用美國Abbott Laboratories生產的HAVAB 2.0試劑,利用微粒子酶免疫分析與電化學髮光免疫測定法(MEIA)檢測1、2、4週以及12箇月的HAV-IgG抗體水平.結果 各組未髮現嚴重不良反應,不良反應主要錶現為髮熱、接種部位疼痛、硬結等.國產HepA-L和HepA-I組不良反應髮生率分彆為13.95％和15.25％,暘性對照組為16.80％,陰性對照組為25.62％,各組間差異無統計學意義.接種2週後,國產HepA-L和HepA-I抗體暘轉率分彆為85.00％和94.59％；接種後第4週,抗體暘轉率達到100％；接種2、4、12週時試驗組、暘性對照組HAV-IgG抗體水平高于陰性對照組；接種12箇月後,國產HepA-I組甲肝抗體水平高于暘性對照組.結論 國產HepA-L和HepA-I以及進口HepA-I安全性良好,均具有較好的免疫效果.
목적 평개중국갑형간염(갑간)감독활역묘(HepA-L)화갑간멸활역묘(HepA-Ⅰ)적안전성급면역효과,위갑간폭발역정역묘응급접충제공삼고의거.방법 용미국아배(Abbott)공사생산적항갑간병독항체(항-HAV)시제사사미감염HAV적6～9세인동.장입선대상수궤분위4조,분별접충국산HepA-L화HepA-I,이국산중조을간역묘(양주효모)(HepB-SCY)위음성대조,GlaxoSmithKline Biologicals S.A.(GSK)생산적HepA-I위양성대조,채취수궤쌍맹방법관찰접충역묘후30 min급24、48、72 h적불량반응발생솔.채용미국Abbott Laboratories생산적HAVAB 2.0시제,이용미입자매면역분석여전화학발광면역측정법(MEIA)검측1、2、4주이급12개월적HAV-IgG항체수평.결과 각조미발현엄중불량반응,불량반응주요표현위발열、접충부위동통、경결등.국산HepA-L화HepA-I조불량반응발생솔분별위13.95％화15.25％,양성대조조위16.80％,음성대조조위25.62％,각조간차이무통계학의의.접충2주후,국산HepA-L화HepA-I항체양전솔분별위85.00％화94.59％；접충후제4주,항체양전솔체도100％；접충2、4、12주시시험조、양성대조조HAV-IgG항체수평고우음성대조조；접충12개월후,국산HepA-I조갑간항체수평고우양성대조조.결론 국산HepA-L화HepA-I이급진구HepA-I안전성량호,균구유교호적면역효과.
Objective To evaluate the safety of both domestic live attenuated and inactivated hepatitis A vaccines,and to provide reference for emergent vaccination after hepatitis A outbreaks.Methods 493 children aged 6-9 with negative antibody to HAV (produced by Abbott) were randomly divided into four groups as vaccinated with domestic live attenuated hepatitis A vaccine (Group A),domestic inactivated hepatitis A vaccine (Group B),imported inactivated hepatitis A vaccine (Group C) and hepatitis B vaccine (Group D) respectively.Adverse events following the immunization were observed 30 minutes,24,48 and 72 hours after the vaccination,under doubleblind method.Results The main AEFIs were:fever,local pain and scleroma but no other severe AEFIs were obvserved.The rates of AEFIs were 13.95％ in Group A,15.25％ in group B,16.80％ in group C and 25.62％ in group D,with no statistical differences between these groups (x2=6.953,P＞0.05).2 weeks after the vaccination,the positive conversion rates of domestic live attenuated hepatitis A vaccine and domestic inactivated hepatitis A vaccine were 85.00％ and 94.59％ respectively.The rate of domestic inactivated hepatitis A vaccine reached 100％ at 4 weeks after the vaccination.The antibody levels of HAV-IgG of Group A and B in 2,4 and 12 weeks of vaccination and of Group C were higher than that of Group D.After 12 weeks of vaccination,the antibody level of group B became higher than it was Group C.Conclusion There were no differences on safety among domestic live attenuated hepatitis A vaccine,domestic inactivated hepatitis A vaccine or imported inactivated hepatitis A vaccine under routine or emergency vaccination.All the vaccines showed satisfactory effects.
