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