Safety, Humoral and Cell Mediated Immune Responses to Two Formulations of an Inactivated, Split-Virion Influenza AH5N1 Vaccine in Children 英文参考文献.docVIP

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Safety, Humoral and Cell Mediated Immune Responses to Two Formulations of an Inactivated, Split-Virion Influenza AH5N1 Vaccine in Children 英文参考文献.doc

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Safety, Humoral and Cell Mediated Immune Responses to Two Formulations of an Inactivated, Split-Virion Influenza AH5N1 Vaccine in Children 英文参考文献

Safety,HumoralandCellMediatedImmuneResponses toTwoFormulationsofanInactivated,Split-Virion InfluenzaA/H5N1VaccineinChildren TaweeChotpitayasunondh1,UsaThisyakorn2,ChitsanuPancharoen2,StephaniePepin3* ,Nolwenn Nougarede3 1QueenSirikitNationalInstituteofChildHealth,Bangkok,Thailand,2ChulalongkornHospital,Bangkok,Thailand,3sanofipasteur,Marcyl’Etoile,France Abstract Background:HighlypathogenicinfluenzaA/H5N1hascausedoutbreaksinwildbirdsandpoultryinAsia,AfricaandEurope. Ithasalsoinfectedpeople,especiallychildren,causingsevereillnessanddeath.Althoughthevirusshowslimitedabilityto transmitbetweenhumans,A/H5N1representsapotentialsourceofthenextinfluenzapandemic.Thisstudyassessesthe safetyandimmunogenicityofaluminiumhydroxideadjuvanted(Al)andnonadjuvantedinfluenzaA/Vietnam/1194/2004 NIBRG-14(H5N1)vaccineinchildren. MethodsandFindings:InaPhaseII,open,randomised,multicentretrial180childrenaged6monthsto17yearsreceived twoinjections,21daysapart,ofvaccinecontainingeither:30mghaemagglutinin(HA)withadjuvant(30mg+Al)or7.5mg HA without adjuvant. An additional 60 children aged 6–35 months received two ‘‘half dose’’ injections (ie 15mg+Al or 3.8mg).Safetywasfollowedfor21daysaftervaccination.Antibodyresponseswereassessed21daysaftereachinjection and cellular immune responses were explored. Vaccination appeared well tolerated in all age groups. The 30mg+Al formulation was more immunogenic than 7.5mg in all age groups: in these two groups 79% and 46% had haemagglutinination inhibition antibody titres $32 (1/dil). Among 6–35 month-olds, the full doses were more immunogenicthantheirhalfdoseequivalents.VaccinationinducedapredominantlyTh2responseagainstH5HA. Conclusions:ThisinfluenzaA(H5N1)vaccinewaswelltoleratedandimmunogenicinchildrenandinfants,withAladjuvant providing a clear immunogenic advantage. These results demonstrate that an H5N1 Al-adjuvanted vaccine, previously showntobeimmunogenicandsafeinadults,canalsobeusedinchildren,thegroupmostatriskforpandemicinfluenza. TrialRegistrati