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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
2U19AI104209-06
Application #
9463228
Study Section
Special Emphasis Panel (ZAI1)
Project Start
2013-07-01
Project End
2024-01-31
Budget Start
2019-02-01
Budget End
2020-01-31
Support Year
6
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Stanford University
Department
Type
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94304
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