acyw135群脑膜炎球菌多糖疫苗安全性和免疫原性研究

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1、ACYW135群脑膜炎球菌多糖疫苗安全性和免疫原性研究摘要目的研究四价脑膜炎球菌多糖疫苗免疫后抗体阳转情况及安全性，为制订防治策略提供依据。方法符合要求的810名受试者接种四价脑膜炎球菌多糖疫苗，接种疫苗后观察30分钟即时反应，系统随访受试者72小时,并定期随访4-6周，检测并分析比较其抗体阳转（4倍增长）率、抗体几何平均滴度（GMT）及不良反应率。结果免疫后A、C、W135、Y群脑膜炎球菌血清杀菌抗体阳转（4倍增长）率为98.14%、97.61%、96.82%、98.84%，抗体GMT分别为1︰250.41、1︰263.16、1︰173.36、1︰196.81，试验组与对照组、不同年龄组

2、间免疫后抗体阳转（4倍增长）率无统计学差异，幼儿、儿童组抗体水平高于成人组，未观察到严重不良反应，达到预期疗效。结论成都康华生物制品有限公司的ACYW135群脑膜炎球菌多糖疫苗安全性良好，有效性极高，免疫预防中医生可放心推广使用该疫苗，对减少流脑发病数有重要意义。关键词流脑；流脑疫苗；抗体检测AstudyonsafetyandimmunogenicityofA、C、Y、W135groupofepidemiccerebrospinalmeningitispolysaccharidevaccineCaiYong,ZhouRong,LiShengyou,HouWenli,FengXiaoChen

3、gduKanghuaBiologicalProductsCo.,Ltd.No.182BeijingRoadChengdu,ChinaAbstractObjectiveStudytheantibodypositiveconversionratesandsafetyoftetravalentmeningococcalpolysaccharidevaccinetoprovidereferencesforaeffectivepreventiveandcurativemeasure.MethodsImmunize810healthyvolunteerswithtetravalentmeningoco

4、ccalpolysaccharidevaccine，observed30minutesofinstantresponseaftervaccination,subjectsweresystematicfollow-upvisitedof72hoursandregularfollow-upvisited4～6weeks．Determinationoftheantibodypositiveseroconversionrates、antibodygeometricmeantiter(GMT)andtheadversereactionrate.ResultsAfterimmunizedtheA、C、

5、Y、W135groupofepidemiccerebrospinalmeningitisserumbactericidalantibodiespositiveconversionratesare98.14%、97.61%、96.82%、98.84%,antibody15geometricmeantiter(GMT)are1︰250.41、1︰263.16、1︰173.36、1︰196.81,Afterimmunized,thetestgroupandthecontrolgroup,antibodypositiveseroconversionratesarenostatisticaldiff

6、erenceamongdifferentagegroups,children'sgroupantibodylevelsthantheadultgroup,Noseriousadverseeffectswereobserved.Theexperimentsachievethedesiredeffect.ConclusionstheA、C、Y、W135groupofepidemiccerebrospinalmeningitispolysaccharidevaccineproducedbychengdukanghuabiologicalsProductsCo.,Ltdhasamildreacti

7、onrateandgoodsafety,immunogenicitycanbewildlyusedamongpeopleof2～16age.Itisimportanttoreducetheincidenceofepidemiccerebrospinalmeningitis.Keywordssafety;efficacy;A、C、Y、W135groupofepidemiccerebrospinalmeningitispol