Safety and Immunogenicity of the Malaria Vaccine Candidate MSP3 Long Synthetic Peptide in 12–24 Months-Old Burkinabe Children 英文参考文献.docVIP

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Safety and Immunogenicity of the Malaria Vaccine Candidate MSP3 Long Synthetic Peptide in 12–24 Months-Old Burkinabe Children 英文参考文献.doc

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Safety and Immunogenicity of the Malaria Vaccine Candidate MSP3 Long Synthetic Peptide in 12–24 Months-Old Burkinabe Children 英文参考文献

SafetyandImmunogenicityoftheMalariaVaccine CandidateMSP3LongSyntheticPeptidein12–24 Months-OldBurkinabeChildren SodiomonB.Sirima1,2*,AlfredB.Tiono1,AlphonseOue′draogo1,AmidouDiarra1,Andre′ Lin Oue′draogo1,JeanBaptisteYaro1,Espe′ranceOue′draogo1,AdamaGansane′1,EdithC.Bougouma1, AmadouT.Konate′1,YoussoufKabore′1,AbdoulayeTraore′1,2,ChilengiRoma3,IssiakaSoulama1 ,Adrian J.F.Luty4,SimonCousens5,IssaNe′bie′1 1CentreNationaldeRechercheetdeFormationsurlePaludisme,Ouagadougou,BurkinaFaso,2GroupedeRechercheetd’ActionenSante′,Ouagadougou,BurkinaFaso, 3African Malaria Network Trust, Dar es Salaam, Tanzania, 4Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands, 5London School of Hygiene and TropicalMedicine,London,UnitedKingdom Abstract Background: A Phase Ia trial in European volunteers of the candidate vaccine merozoite surface protein 3 (MSP3), a Plasmodium falciparum blood stage membrane, showed that it induces biologically active antibodies able to achieve parasitekillinginvitro,whileaphaseIbtrialinsemi-immuneadultvolunteersinBurkinaFasoconfirmedthatthevaccine wassafe. Theaimofthisstudywastoassessthesafetyandimmunogenicityofthisvaccinecandidateinchildrenaged12– 24monthslivinginmalariaendemicareaofBurkinaFaso. Methods: The study was a double-blind, randomized, controlled, dose escalation phase Ib trial, designed to assess the safety, reactogenicity and immunogenicity of three doses of either 15 or 30mg of MSP3-LSP adsorbed on aluminum hydroxidein45children12to24monthsofagerandomizedintothreeequalgroups.Eachgroupreceived3vaccinedoses (ondays0,28and56)ofeither15mgofMSP3-LSP,30 mgofMSP3-LSPoroftheEngerixBhepatitisBvaccine.Childrenwere visitedathomedailyforthe6daysfollowingeachvaccinationtosolicitsymptomswhichmightberelatedtovaccination. Seriousadverseeventsoccurringduringthestudyperiod(1year)wererecorded.AntibodyresponsestoMSP3-LSPwere measuredondays0,28,56and84. Results:All45enrolledchildrenreceivedthreeMSP3vaccinedoses.Noseriousadverseeventswerere