Blood Stage Malaria Vaccine Eliciting High Antigen-Specific Antibody Concentrations Confers No Protection to Young Children in Western Kenya 英文参考文献.docVIP

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Blood Stage Malaria Vaccine Eliciting High Antigen-Specific Antibody Concentrations Confers No Protection to Young Children in Western Kenya 英文参考文献.doc

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Blood Stage Malaria Vaccine Eliciting High Antigen-Specific Antibody Concentrations Confers No Protection to Young Children in Western Kenya 英文参考文献

BloodStageMalariaVaccineElicitingHighAntigen- SpecificAntibodyConcentrationsConfersNoProtection toYoungChildreninWesternKenya BernhardsR.Ogutu1*,OdikaJ.Apollo1,DeniseMcKinney1,WillisOkoth1,JoramSiangla1 ,Filip Dubovsky2,KathrynTucker3,JohnN.Waitumbi1,CarterDiggs4,JanetWittes3,ElissaMalkin2 ,Amanda Leach5,LorraineA.Soisson4,JessicaB.Milman2,LucasOtieno1,CarolynA.Holland6,MarkPolhemus1, ShonA.Remich1,ChristianF.Ockenhouse6,JoeCohen5,W.RipleyBallou5,SamuelK.Martin1 ,Evelina Angov6,V.AnnStewart6,JeffreyA.Lyon6,D.GrayHeppner,Jr.6,MarkR.Withers1fortheMSP-1Malaria VaccineWorkingGroup 1USArmy MedicalResearchUnit-Kenya and the Centre for Clinical Research, KenyaMedical Research Institute, Nairobi,Kenya, 2ThePATHMalariaVaccine Initiative, Bethesda,Maryland,UnitedStatesofAmerica,3StatisticsCollaborative,Inc.,Washington,D.C.,UnitedStatesofAmerica,4MalariaVaccineDevelopmentProgram,US AgencyforInternationalDevelopment,Washington,D.C.,UnitedStatesofAmerica,5GlaxoSmithKlineBiologicalss.a.,Rixensart,Belgium,6DivisionofMalariaVaccine Development,WalterReedArmyInstituteofResearch,SilverSpring,Maryland,UnitedStatesofAmerica Abstract Objective: The antigen, falciparum malaria protein 1 (FMP1), represents the 42-kDa C-terminal fragment of merozoite surface protein-1 (MSP-1) of the 3D7 clone of P. falciparum. Formulated with AS02 (a proprietary Adjuvant System), it constitutestheFMP1/AS02candidatemalariavaccine.Weevaluatedthisvaccine’ssafety,immunogenicity,andefficacyin Africanchildren. Methods:Arandomised,double-blind,PhaseIIb,comparator-controlledtrial.Thetrialwasconductedin13fieldstationsof one mile radii within Kombewa Division, Nyanza Province, Western Kenya, an area of holoendemic transmission of P. falciparum.Weenrolled400childrenaged12–47monthsingeneralgoodhealth.Childrenwererandomisedina1:1fashion toreceiveeitherFMP1/AS02(50mg) orRabipurH rabiesvaccine.Vaccinations wereadministeredon a0, 1,and2 month schedule.TheprimarystudyendpointwastimetofirstclinicalepisodeofP.falcip