Safety, Immunogenicity and Duration of Protection of the RTS,SAS02D Malaria Vaccine One Year Follow-Up of a Randomized Controlled Phase IIIb Trial 英文参考文献.docVIP

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Safety, Immunogenicity and Duration of Protection of the RTS,SAS02D Malaria Vaccine One Year Follow-Up of a Randomized Controlled Phase IIIb Trial 英文参考文献.doc

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Safety,ImmunogenicityandDurationofProtectionof theRTS,S/AS02DMalariaVaccine:OneYearFollow-Upof aRandomizedControlledPhaseI/IIbTrial PedroAide1,3*,JohnJ.Aponte1,2,MontseRenom1,2,TaciltaNhampossa1,3,JahitSacarlal1,4 ,Inacio Mandomando1,3,QuiqueBassat1,2,MariaNe′liaManaca1,AmandaLeach5,MarcLievens5 ,Johan Vekemans5,Marie-ClaudeDubois5,ChristianLoucq6,W.RipleyBallou5,JoeCohen5,PedroL.Alonso1,2 1Centro de Investigac?a?o em Sau′de da Manhic?a (CISM), Maputo, Mozambique, 2Barcelona Centre for International Health Research, Hospital Clinic, University of Barcelona, Barcelona, Spain, 3Instituto Nacional de Sau′de, Ministe′rio de Sau′de, Maputo, Mozambique, 4Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo,Mozambique,5Glaxo-SmithKlineBiologicals,Rixensart,Belgium,6PATHMalariaVaccineInitiative,Bethesda,Maryland,UnitedStatesofAmerica Abstract Background: The RTS,S/AS02D vaccine has been shown to have a promising safety profile, to be immunogenic and to conferprotectionagainstmalariainchildrenandinfants. MethodsandFindings:Wedidarandomized,controlled,phaseI/IIbtrialofRTS,S/AS02Dgivenat10,14and18weeksof agestaggeredwithroutineimmunizationvaccinesin214Mozambicaninfants.Thestudywasdouble-blinduntiltheyoung childcompleted6monthsoffollow-upoverwhichperiodvaccineefficacyagainstnewPlasmodiumfalciparuminfections was estimated at 65.9% (95% CI 42.6–79.8, p,0.0001). We now report safety, immunogenicity and estimated efficacy againstclinicalmalariaupto14monthsafterstudystart.VaccineefficacywasassessedusingCoxregressionmodels.The frequencyofseriousadverseeventswas32.7%intheRTS,S/AS02Dand31.8%inthecontrolgroup.Thegeometricmean titers of anti-circumsporozoite antibodies declined from 199.9 to 7.3EU/mL from one to 12 months post dose three of RTS,S/AS02D,remaining15-foldhigherthaninthecontrolgroup.Vaccineefficacyagainstclinicalmalariawas33%(95%CI: 24.3–56.9, p=0.076) over 14 months of follow-up. The hazard rate of disease per 2-fold increase in anti-CS titters was reducedby84%(95