Randomized Controlled Trial of RTS,SAS02D and RTS,SAS01E Malaria Candidate Vaccines Given According to Different Schedules in Ghanaian Children 英文参考文献.docVIP

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Randomized Controlled Trial of RTS,SAS02D and RTS,SAS01E Malaria Candidate Vaccines Given According to Different Schedules in Ghanaian Children 英文参考文献.doc

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Randomized Controlled Trial of RTS,SAS02D and RTS,SAS01E Malaria Candidate Vaccines Given According to Different Schedules in Ghanaian Children 英文参考文献

Randomized Controlled Trial of RTS,S/AS02D and RTS,S/AS01E Malaria Candidate Vaccines Given According toDifferent Schedules inGhanaian Children SethOwusu-Agyei1,2*,DanielAnsong3,KwakuAsante1,SandraKwartengOwusu3,RuthOwusu1 ,Naana AyiwaWirekoBrobby3,DavidDosoo1,AlexOseiAkoto3,KingsleyOsei-Kwakye1,EmmanuelAsafo Adjei3,KwadwoOwusuBoahen1,JusticeSylverken3,GeorgeAdjei1,DavidSambian3,StephenApanga1, KingsleyKayan1,JohanVekemans4,OpokuaOfori-Anyinam4,AmandaLeach4,MarcLievens4, Marie-AngeDemoitie4,Marie-ClaudeDubois4,JoeCohen4,W.RipleyBallou5,BarbaraSavarese6 ,Daniel Chandramohan2,JohnOwusuGyapong7,PaulMilligan2,SampsonAntwi3,TsiriAgbenyega3 ,Brian Greenwood2,JenniferEvans8 1KintampoHealthResearchCentre,HealthResearchUnit,Kintampo,Ghana,2LondonSchoolofHygieneandTropicalMedicine,London,UnitedKingdom,3Schoolof Medical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana, 4GlaxoSmithKline Biologicals, Rixensart, Belgium, 5Bill and Melinda Gates Foundation,Seattle,Washington,UnitedStatesofAmerica,6PATHMalariaVaccineInitiative,Bethesda,Maryland,UnitedStatesofAmerica,7HealthResearchUnit,Ghana HealthService,MinistryofHealth,Accra,Ghana,8KumasiCentreforCollaborativeResearch,Kumasi,Ghana Abstract Background:ThetargetdeliverychannelofRTS,Scandidatemalariavaccinesinmalaria-endemiccountriesinAfricaisthe WorldHealthOrganisationExpandedProgramonImmunization.AsanAdjuvantSystem,agede-escalationandschedule selectionstep,thisstudyassessed3schedulesofRTS,S/AS01EandRTS,S/AS02Dininfantsandyoungchildren5–17months ofageinGhana. Methodology: A Phase II, partially-blind randomized controlled study (blind to vaccine, not to schedule), of 19 months durationwasconductedintwo(2)centresinGhanabetweenAugust2006andMay2008.Subjectswereallocatedrandomly (1:1:1:1:1:1)tooneofsixstudygroupsateachstudysite,eachdefiningwhichvaccineshouldbegivenandbywhichschedule (0,1-,0,1,2-or0,1,7-months).Forthe0,1,2-monthscheduleparticipantsreceivedRTS,S/AS01Eorrabiesvaccineatonecenter andRTS,S/AS01E