Safety and Immunogenicity of an HIV Adenoviral Vector Boost after DNA Plasmid Vaccine Prime by Route of Administration A Randomized Clinical Trial 英文参考文献.docVIP

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Safety and Immunogenicity of an HIV Adenoviral Vector Boost after DNA Plasmid Vaccine Prime by Route of Administration A Randomized Clinical Trial 英文参考文献.doc

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Safety and Immunogenicity of an HIV Adenoviral Vector Boost after DNA Plasmid Vaccine Prime by Route of Administration A Randomized Clinical Trial 英文参考文献

SafetyandImmunogenicityofanHIVAdenoviralVector BoostafterDNAPlasmidVaccinePrimebyRouteof Administration:ARandomizedClinicalTrial BerylA.Koblin1*,MartinCasapia2,CeciliaMorgan3,LiQin3,ZhixueMaggieWang3,OlivierD.Defawe3, LindseyBaden4,PaulGoepfert5,GeorgiaD.Tomaras6,DavidC.Montefiori6,M.JulianaMcElrath3 ,Lilian Saavedra2,Chuen-YenLau7,BarneyS.Graham8,TheNIAIDHIVVaccineTrialsNetwork 1LaboratoryofInfectiousDiseasePrevention,NewYorkBloodCenter,NewYork,NewYork,UnitedStatesofAmerica,2AsociacionCivilSelvaAmazonica,Iquitos,Peru, 3VaccineandInfectiousDisease Division, FredHutchinsonCancerResearchCenter, Seattle,Washington, UnitedStates ofAmerica, 4Brigham andWomen’sHospital, HarvardMedicalSchool,Boston,Massachusetts,UnitedStatesofAmerica,5DepartmentofMedicine,UniversityofAlabamaatBirmingham,Birmingham,Alabama,United StatesofAmerica,6DepartmentofSurgery,DukeUniversityMedicalCenter,Durham,NorthCarolina,UnitedStatesofAmerica,7DivisionofClinicalResearch,National InstituteofAllergyandInfectiousDiseases,NationalInstitutesofHealth,Bethesda,Maryland,UnitedStatesofAmerica,8VaccineResearchCenter,NationalInstituteof AllergyandInfectiousDiseases,NationalInstitutesofHealth,Bethesda,Maryland,UnitedStatesofAmerica Abstract Background:InthedevelopmentofHIVvaccines,improvingimmunogenicitywhilemaintainingsafetyiscritical.Routeof administrationcanbeanimportantfactor. Methodology/Principal Findings: This multicenter, open-label, randomized trial, HVTN 069, compared routes of administrationonsafetyandimmunogenicityofaDNAvaccineprimegivenintramuscularlyat0,1and2monthsanda recombinant replication-defective adenovirus type 5 (rAd5) vaccine boost given at 6 months by intramuscular (IM), intradermal (ID), or subcutaneous (SC) route. Randomization was computer-generated by a central data management center; participants and staff were not blinded to group assignment. The outcomes were vaccine reactogenicity and humoralandcellularimmunogenicity.Ninetyhealthy,HIV-1uninfectedadultsintheUSandPeru,aged