2025
Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study
Hamer M, McCarty J, Pierson B, Regules J, Mendy J, Sanborn A, Gardner C, Haller J, Gregory M, Liggett D, Glass P, Ghosh N, Royalty Tredo S, Warfield K, Burke C, Lee C, Saunders D, Bedell L, Richardson J. Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study. The Lancet Microbe 2025, 101000. PMID: 39954701, DOI: 10.1016/j.lanmic.2024.101000.Peer-Reviewed Original ResearchGeometric mean titresCHIKV VLPsVaccine recipientsVLP vaccineAdverse eventsSex-matchedAlphavirus vaccinesOpen-labelParallel-groupAge-matchedVirus-like particlesPrimary immunogenicity endpointNeutralising antibodiesVEEV vaccinesAntibody seroconversion ratesPhase 2 randomised controlled trialFisher's exact testClinical study sitesStatistically significant differenceImmunogenicity endpointsSeroconversion ratesCompare immunogenicitySingle doseAntibody increaseExact test
2024
Longitudinal phase 2 clinical trials of live, attenuated tularemia vaccine in healthy research laboratory workers
Saunders D, Pierson B, Haller J, Norris S, Cardile A, Reisler R, Okwesili A, Boudreau E, Rusnak J, Danner D, Purcell B, Barth J, Tompkins E, Downs I, Liggett D, Pettit P, Pratt T, Goldberg M, Kortepeter M, Guerena F, Aldis J, Keshtkar-Jahromi M, Pittman P. Longitudinal phase 2 clinical trials of live, attenuated tularemia vaccine in healthy research laboratory workers. Frontiers In Bacteriology 2024, 2: 1289461. DOI: 10.3389/fbrio.2023.1289461.Peer-Reviewed Original ResearchLive vaccine strainLaboratory workersClinical trialsPhase 2 clinical trialPrimary immunogenicity endpointIntracellular bacterium Francisella tularensisMultiple clinical trialsHuman challenge studiesInvestigational new drug applicationRisk laboratory workersBacterium Francisella tularensisImmunogenicity endpointsInitial vaccinationSecond doseHigh morbidityAerosol doseSingle doseVaccine protocolsTularemia vaccineWeek 4Comparator dataMortality rateNew drug applicationsResponse ratePneumonic disease
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