First-in-Man Open Clinical Trial of a Combined rdESAT-6 and rCFP-10 Tuberculosis Specific Skin Test Reagent 英文参考文献.docVIP

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First-in-Man Open Clinical Trial of a Combined rdESAT-6 and rCFP-10 Tuberculosis Specific Skin Test Reagent 英文参考文献.doc

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First-in-Man Open Clinical Trial of a Combined rdESAT-6 and rCFP-10 Tuberculosis Specific Skin Test Reagent 英文参考文献

First-in-ManOpenClinicalTrialofaCombinedrdESAT-6 andrCFP-10TuberculosisSpecificSkinTestReagent WinnieBergstedt1,PernilleN.Tingskov2,BirgitThierry-Carstensen2,S?renT.Hoff3,HenrikAggerbeck2, VibekeO.Thomsen4,PeterAndersen3,AaseB.Andersen1* 1DepartmentofInfectiousDiseases,Rigshospitalet,UniversityofCopenhagen,Copenhagen,Denmark,2DepartmentofVaccineDevelopment,StatensSerumInstitut, Copenhagen, Denmark, 3Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark, 4International Reference Laboratory of Mycobacteriology,NationalCentreforAntimicrobialsandInfectionControl,StatensSerumInstitut,Copenhagen,Denmark Abstract Background:Tuberculinisstilltheonlyavailableskintestreagentforthediagnosisofmycobacterialinfection.Theproduct hasaremarkablesensitivity,butpoorspecificity.Previousstudies,includingtwohumanphaseIclinicaltrials,haveindicated that rdESAT-6 has a potential as an improved skin test reagent. Animal studies have shown that the sensitivity may be increasedbyinclusionofthegeneticallyrelatedCFP-10antigeninthepreparationwithoutloosingspecificity. Methodology:InthisstudyaLactococcusfermented,recombinantskintestreagentconsistingofa1:1wt/wtofrdESAT-6 andCFP-10wasmanufacturedaccordingtoGMPstandardsandtestedforthefirsttimein42healthyadultvolunteers.The two doses of 0.01mg or 0.1mg were injected intradermally by the Mantoux technique with 6 or 12 weeks interval. No seriousadverseeventsandonlymildadversereactionswerereported.Thereagentelicitedapositiveskintestreactionafter thefirstinjectioninoneparticipant,whomostlikelywaslatentlyinfectedwithM.tuberculosisasindicatedbyanappreciable IFNcresponsejustbelowtheQuantiferonHcut-offlevelatthescreeningvisit.Noneoftheremainingparticipantsinthe fourgroupshadanyskintestreactionsandsensitisationbythereagentcouldthereforebeexcluded. Conclusion:TheinvestigationalskintestreagentrdESAT-6andCFP-10appearedsafeandnon-sensitisinginthisfirst-in-man clinical trial in human volunteers and can now be tested in larger cl