Safety and Immunogenicity of an AMA1 Malaria Vaccine in Malian Children Results of a Phase 1 Randomized Controlled Trial 英文参考文献.docVIP

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Safety and Immunogenicity of an AMA1 Malaria Vaccine in Malian Children Results of a Phase 1 Randomized Controlled Trial 英文参考文献.doc

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Safety and Immunogenicity of an AMA1 Malaria Vaccine in Malian Children Results of a Phase 1 Randomized Controlled Trial 英文参考文献

SafetyandImmunogenicityofanAMA1MalariaVaccine inMalianChildren:ResultsofaPhase1Randomized ControlledTrial MahamadouA.Thera1,OgobaraK.Doumbo1,DrissaCoulibaly1,MatthewB.Laurens2,AbdoulayeK. Kone1,AndoB.Guindo1,KarimTraore1,MadySissoko1,DapaA.Diallo1,IssaDiarra1,BouremaKouriba1, ModiboDaou1,AmaganaDolo1,MounirouBaby1,MahamadouS.Sissoko1,IssakaSagara1 ,Amadou Niangaly1,IdrissaTraore1,AllyOlotu3¤b,OlivierGodeaux3,AmandaLeach3,Marie-ClaudeDubois3 ,W. RipleyBallou3¤a,JoeCohen3,DarbyThompson4,TinaDube4,LorraineSoisson5,CarterL.Diggs5, ShannonL.Takala2,KirstenE.Lyke2,BrentHouse6,DavidE.Lanar6,SheetijDutta6,D.GrayHeppner6, ChristopherV.Plowe2* 1MalariaResearchandTrainingCenter,UniversityofBamako,Bamako,Mali,2HowardHughesMedicalInstitute/CenterforVaccineDevelopment,UniversityofMaryland SchoolofMedicine,Baltimore,Maryland,UnitedStatesofAmerica,3GlaxoSmithKlineBiologicals,Rixensart,Belgium,4EMMESCorporation,Rockville,Maryland,United StatesofAmerica,5MalariaVaccineDevelopmentProgram,U.S.AgencyforInternationalDevelopment,Washington,D.C.,UnitedStatesofAmerica,6DivisionofMalaria VaccineDevelopment,WalterReedArmyInstituteofResearch,SilverSpring,Maryland,UnitedStatesofAmerica Abstract Background: The objectivewastoevaluatethesafetyandimmunogenicity oftheAMA1-basedmalariavaccine FMP2.1/ AS02Ainchildrenexposedtoseasonalfalciparummalaria. Methodology/Principal Findings: A Phase 1 double blind randomized controlled dose escalation trialwas conducted in Bandiagara,Mali,WestAfrica,aruraltownwithintenseseasonaltransmissionofPlasmodiumfalciparummalaria.Themalaria vaccineFMP2.1/AS02Aisarecombinantprotein(FMP2.1)basedonapicalmembraneantigen1(AMA1)fromthe3D7clone ofP.falciparum,formulatedintheAdjuvantSystemAS02A.Thecomparatorvaccinewasacell-culturerabiesvirusvaccine (RabAvertH).OnehundredhealthyMalianchildrenaged1–6yearswererecruitedinto3cohortsandrandomizedtoreceive either10mgFMP2.1in0.1mLAS02A,or25mgFMP2.1in0.25mLAS02A,or50mgFMP2.150mgin0.5mLAS02A,orrabies vaccine.Threedosesofvaccinewer