TheDataManagementandAnalysisCore(CoreC)willinteractimportantlywitheachofthe4projects, andtheScientificCoreB.Wehavedevelopedadetailedplantooptimizethesynergyandinteractionsamong theprojects,coresandpersonnelinvolvedinthestudiesproposedinthisU19applicationforacoordinated dataanalysisstrategy.Notably,themembersofeachoftheProjectsandCoresarealreadyinteracting scientifically,andhavepublishedtogetherinallergyresearch.Accordingly,shouldthisrenewalapplicationbe funded,theproposedworktoadvanceourunderstandingofthepathologyofhumanfoodallergy,andthe mechanismsthatcontributetotherapeuticresponsestooralimmunotherapywithmultiplefoodallergens(multi- OIT)withorwithoutthebiologictherapeuticsomalizumabordupilumab(theCOMBINEtrial)willrepresenta continuationandexpansionoftheseongoingcollaborativeefforts. TheDataManagementandAnalysisCorehasthreeSpecificAims:
Aim1 :Providedataanalysisandstatisticalsupportforthepilotphase2clinicaltrialofProject1,evaluating whethertreatmentwithmulti-OITcombinedwitheitheromalizumabordupilumabvs.multi-OITaloneresultsin ahigherproportionofparticipantsbeingabletopassafoodchallengeatweek24(primaryendpoint)andafter aperiodofwithdrawalatweek30(asecondaryendpoint)inmulti-foodallergicpatientstreatedwithmulti-OIT, andalsoanalyzingongoingsafetydatacollectedinthecourseofthetrial.
Aim2 :Provideintegratedandcoordinatedstatisticalanalysisoftheclinicalandimmunologicalassaydata thatwillbecollectedbyProjects1,2,3and4,andtheScientificCoreB,toattempttoidentifyimmune systemfeaturesthatarepredictiveofwhetherornotmulti-foodallergicparticipantswillachieve desensitization,orpotentiallysustainedunresponsivenessaftermulti-OIT,andtoattempttoidentifyimmune systemfeaturesthatcanbeusedtoidentifyindividualsatincreasedriskofexperiencingadversereactionsto OIT.Wewillalsoanalyzelong-termfollowupspecimensfromourpriorongoingPOISEDandcompleted MAPXtrials,toassesswhethertherearecorrelationsbetweenimmunologicalassayresultsandlong-term clinicaloutcomes.
Aim3 :WorkwithProject1andScientificCoreBtobuildandmaintaindatabasesorganizingtheclinical andlaboratorydataobtainedinProjects1,2,3and4andCoreB,tofacilitatesharingandanalysisofdata fromtheCOMBINEtrialandprojects,andalsofromlongtermfollow-upstudiesofparticipantsinourPOISED andMAPXtrials.
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| Chinthrajah, R Sharon; Purington, Natasha; Andorf, Sandra et al. (2018) Development of a tool predicting severity of allergic reaction during peanut challenge. Ann Allergy Asthma Immunol 121:69-76.e2 |
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