Safety and Immunogenicity of Boosting BCG Vaccinated Subjects with BCG Comparison with Boosting with a New TB Vaccine, MVA85A 英文参考文献.docVIP

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Safety and Immunogenicity of Boosting BCG Vaccinated Subjects with BCG Comparison with Boosting with a New TB Vaccine, MVA85A 英文参考文献.doc

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Safety and Immunogenicity of Boosting BCG Vaccinated Subjects with BCG Comparison with Boosting with a New TB Vaccine, MVA85A 英文参考文献

SafetyandImmunogenicityofBoostingBCGVaccinated SubjectswithBCG:ComparisonwithBoostingwitha NewTBVaccine,MVA85A KathrynT.Whelan1.,AnsarA.Pathan1.,ClareR.Sander1,HelenA.Fletcher1,IanPoulton2,NicolaC. Alder3,AdrianV.S.Hill1,HelenMcShane1* 1JennerInstitute,UniversityofOxford,ChurchillHospital,Oxford,UnitedKingdom,2CentreforClinicalVaccinologyandTropicalMedicine,ChurchillHospital,Oxford, UnitedKingdom,3CentreforStatisticsinMedicine,UniversityofOxford,Oxford,UnitedKingdom Abstract Objectives:ToinvestigatethesafetyandimmunogenicityofaboosterBCGvaccinationdeliveredintradermallyinhealthy, BCGvaccinatedsubjectsandtocomparewithapreviousclinicaltrialwhereBCGvaccinatedsubjectswereboostedwitha newTBvaccine,MVA85A. Design:PhaseIopenlabelobservationaltrial,intheUK.Healthy,HIV-negative,BCGvaccinatedadultswererecruitedand vaccinatedwithBCG.Theprimaryoutcomewassafety;thesecondaryoutcomewascellularimmuneresponsestoantigen 85, overlapping peptides ofantigen 85A andtuberculin purified proteinderivative (PPD)detected by exvivo interferon- gamma(IFN-c)ELISpotassayandflowcytometry. ResultsandConclusions:BCGrevaccination(BCG-BCG)waswelltolerated,andboostingofpre-existingPPD-specificTcell responseswasobserved.However,whentheseresultswerecomparedwithdatafromapreviousclinicaltrial,whereBCG was boosted with MVA85A (BCG-MVA85A), MVA85A induced significantly higher levels (.2-fold) of antigen 85-specific CD4+ T cells (both antigen and peptide pool responses) than boosting with BCG, up to 52 weeks post-vaccination (p=0.009).Toidentifyantigen85A-specificCD8+TcellsthatwerenotdetectablebyexvivoELISpotandflowcytometry, dendritic cells (DC) were used to amplify CD8+ T cells from PBMC samples. We observed low, but detectable levels of antigen 85A-specific CD8+ T cells producing IFNc (1.5% of total CD8 population) in the BCG primed subjects after BCG boostingin1(20%)of5subjects.Incontrast,inBCG-MVA85Avaccinatedsubjects,highlevelsofantigen85A-specificCD8+ Tcells(upto14%totalCD8population)wereobservedaft