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1、摘要目的:评价不同时间间隔接种2剂水痘减毒活疫苗的安全性、免疫效果和免疫原性。方法:将1200名1-12岁儿童按照随机对照原则进行分组。分成两组,分别为治疗组和对照组。治疗组接种2剂冻干水痘减毒活疫苗,时间间隔分别为3个月和6个月,并在免前和免后第7周采集血清样本。对照组全部接种乙肝疫苗,采血时间同治疗组。用膜抗原荧光抗体法(FAMA)检测血清水痘抗体水平;此外,观察每组免后的安全性和免疫原性。结果:免前抗体同年龄组对照组和实验组间血清抗体滴度无统计学差异。同年龄组对照组免前、接种1剂后、2剂后血清抗体滴度无统计学差异。
2、试验组中同年龄组,间隔6个月和3个月接种2剂后血清抗体滴度无统计学差异。血清阳转率亦无统计学差异。接种1剂和2剂水痘疫苗后,1-3岁组、4-6岁组、7-12岁组阳转率分别为92.77%,92.06,88.17%,99.04%,97.35%和95.70%。关键词:水痘疫苗,安全性,免疫原性,两针免疫IAbstractPurpose:Thepurposeofthisstudyistoobservethesafety,immunologicaleffectandimmunogenicityof2-dosevaricellaim
3、munizationschedulewithdifferentintervals.Methods:Thisrandomizedcontrolledtrialinvolved1,200childrenfromtheage1to12.Theyweredividedintotwogroups,treatmentgroupandcontrolgroup.Thetreatmentgroupreceived2dosesoffreeze-driedlivevaricellavaccine.Theintervalofthetwodose
4、swas3monthsand6monthsrespectively.Bloodwassampledbeforetheimmunizationandatthe7thweekaftertheimmunization.ThecontrolgroupreceivedonedosehepatitisBvaccine,andbloodwassampledatthesmetime.Withthemethodoffluorescentantibodymembraneantigen(FAMA),thelevelofchickenpoxwa
5、stested;also,thesafetyandimmunogenicityofeachgroupaftervaccinationwasobserved.Results:Beforetheinoculation,theserumantibodytitersofcontrolgroupandtreatmentgroupofthesameagehadnostatisticaldifference.Beforetheinoculationandduringthesecondandthirdbloodsampling,thes
6、erumantibodytitersofthecontrolgroupofthesameagehadnostatisticaldifference.Aftertheadministrationof2doseswiththeintervalof6monthsand3months,theserumantibodytitersofthetreatmentgroupofthesameagehadnostatisticaldifference.Theseroconversionratehadnostatisticaldiffere
7、nce.Aftertheadministrationof1doseand2doses,thepositiveconversionrateof1-3-year-oldgroup,4-6-year-oldgroupand7-12-year-oldgroupwas92.77%,92.06%,88.17%,99.40%,97.35%and95.70%,respectivelyKeywords:varicellavaccine,Security,immunogenicity,TwoneedleimmuneII目录第1章绪论....
8、.......................................................................................................................11.1水痘带状疱疹概述............................