MVP Access ProgramAccess to Data and Sera collected during the MenAfriVac® clinical trials

LionelMartelletClinicalOpera0onsManager

23February2016TheMVPClosureConference

Presenta;onOverview

1.  AimoftheMVPAccessProgram2.  OverviewofMVPData/SeraCollec0on3.  Loca0onandset-upoftheSeraBank4.  MVPAccessProgramGovernance5.  StepsforAccesstoSeraandData6.  Follow-uptodeliveryofsamples/data7.  Linkforfurtherinforma0on

MVPAccessProgram

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Aqualifiedinves;gatormaybefromthestudysiteormaybefromanotherins0tu0on.However,eachproposalsubmiQedmustincludeatleastonequalifiedinves0gatorfromeachins0tu0onfromwhichdataorseraaretobeu0lized.

AimEstablish a mechanism to enable qualified inves;gators (incollabora0onwithstudysites)toaccessdata/seracollectedduringtheMeningi;s Vaccine Project and answer specific research ques0ons ofpublichealthinterest(excludinggene0cresearch).

Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

PhaseII/III,MaliSenegal,TheGambia

PhaseIIMaliTheGambia

PhaseII/IIIIndia

PhaseIIGhana

PhaseIIIIndia

PhaseIIIMali

PsA-TT-0055-10year-olds,n=830

PsA-TT-006,safetyonly1-29year-olds,n=6000

PhaseIIndia

PsA-TT-0032-29years,n=900

PsA-TT-0021-2years,n=600

PsA-TT-001Adults,n=74

PsA-TT-004Infants,n=1200

WHOPre-Qualifica;on

DCGILicenseforIndia

PediatricIndica;onSubmission

DCGIExportLicense

DCGISubmission

WHOSubmission

PsA-TT-003a2-10year-olds,n=340

PersistencePers-002-003,

n=1223

PhaseIIMali

PsA-TT-007Infants,n=1500

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MVPClinicalDevelopmentProgram

MVPAccessProgramCollec;on(SeraandData)

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Study Studyobjec;ves Ageofenrolledsubjects

Numberofsubjects

PsA-TT-002Phase2

Safety,Immunogenicity,ImmunePersistence(TheGambia,Mali) 12-23months 600

PsA-TT-003Phase2/3

Safety,Immunogenicity,ImmunePersistence,Carriage(The

Gambia,Mali,Senegal) 2-29year-olds 900

PsA-TT-004Phase2

DoseSelec0on,ScheduleEvalua0on,ImmunePersistence(Ghana) 14-18weeks 1200

PsA-TT-007Phase3

ConfirmingSchedule,ExpandingSafety(Mali) 9-12months 1500

Pers-002-003Phase4

Persistencemeasure(TheGambia,Mali,Senegal) 1-29year-olds 1223

5of9ClinicalStudyfiles,CaseReportFormdataandLaboratoryResultsfromfourstudysitesinWestAfrica

MVPSeraBankCollec;on

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•  SamplesfromallAfricanstudies~74,000vials

•  Longtermstorage-80oC•  Samplequan0tyvariesbystudy•  Subjectscontribu0ngserumrangeinages14wksto29yrs.

•  Storagewasmaintainedat-20oC(orlower)atsitesduringstudyconduct

•  Serumsamplequan00escanbeconfirmedpriortoanyshipmenttoensuresamplesmeettheneedsoftheinves0gator

MVPSeraBankCollec;on

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17,670

22,674

11,997

20,280

545 739

PsA-TT-002 PsA-TT-003 PsA-TT-004 PsA-TT-007 Pers-002 Pers-003

Mali,TheGambia Mali,TheGambia,Senegal

Ghana Mali Mali,TheGambia Mali,TheGambia,Senegal

n=600 n=900 n=1200 n=1500 n=509 n=714

1-4yrs 2-30yrs 14wks-4yrs 9mos-19mos 6-7yrs 6-36yrs

70mepoints 40mepoints 80mepoints 40mepoints once once

Numberoftubes(lessthan500µleach)

MVPSeraBank,UniversityofSiena,Italy•  Four-80oCelsiusFreezers(3+1back-up)underrestrictedaccess•  24/7temperaturecontrolledfacili0es•  Databasesystemfortrackingofinventoriesandshipments•  Coordina0onofshipmentsandmonitoringofstorage•  GCLPtrainedstaff•  SOPsystemforQA•  FilingsystemforallSeraBankrecords

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Accountability•  PATHandSIILjointownershipofthesera

•  PATH-SIILcontractUNISIfortheSeraBankopera0on

MVPAccessProgramGovernance

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•  ThegovernanceofthisprogramisestablishedinaspecificMemorandumofUnderstanding(MoU)signedbyPATH,SIILandeachpar0cipa0ngstudysite.

•  TheMoUdefines—  GuidingPrinciplesoftheProgram—  RolesandResponsibili0esofthedifferentpar0es—  StepsforaccesstoeitherSeraorDatahousedfromtheAfricanstudies

•  MoUhaskeysuppor0ngappendices:—  ICFsfromtheMVPClinicalStudies—  Proposaltemplateforsera/datarequest— MaterialTransferAgreement(MTA)Template—  AnalyzedDataTransferAgreement(ADTA)Template

OverviewofstepsforSeraaccess

4.QualifiedInves;gator(s)(QI)submitsaresearchproposalusingthePATHtemplate.AtleastoneQImustbelistedforeachsitewhereserumordataarebeingu0lized.

5.PATHandSIILjointreviewonfirstcomefirstservebasisandsharedecisionwithQIs.

6.Ifposi0vedecisionisobtainedthenallrequiredscien;fic/ERCapprovalsateachQI’ssitemustbesubmiQedalongwiththefinalapprovedprotocol.

7.PATHwillconfirmtheseapproveddocumentsalignwiththeoriginalresearchproposalsubmiQedpriortoexecu0ngamaterialtransferagreement(MTA).

8.TheMTAissignedbyqualifiedinves0gatorsandPATHpriortosamplesordatabeingmadeavailable.

9.AshipmentplanwithEpidMol(UNISI)isestablishedforthetransferofthesamples.PATHmaythenauthorizeshipment

1.Accesswebsiteforpreliminaryinforma;onhQp://www.path.org/menafrivac/advancing-research.phphQp://www.meningvax.org/

2.Requestfurtherinforma;ononstudiesandprocessforsubmikngaresearchproposalfromPATHthroughemailaddress:meningi0sresearch@path.org

3.Basedonspecificinterest,PATHwillinves;gateandconfirmavailabilityofsamplesinserabank

8.Theresearch;tleispostedexternallyonthePATHwebsite

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OverviewofstepsforDataAccess

•  Samestepsforserumaccess•  ThePATHSta0s0cianisresponsibleforconduc0nganalysisandprovidingdataoutputtotheQIs

•  AmertheADTAissigned,anagreedupon0meframewillbeestablishedbetweentheQIsandthePATHSta0s0cianforthereleaseofthedata

Post-accessfollow-upofallApprovedProposals•  Repor0ngtoPATHonresearchac0vi0esbasedonplanned0melines

•  Finaltraceabilityandaccountabilityforallsamples•  Publica0onplancompletedwithappropriateacknowledgementofMVP,StudySites,PATHandSIIL.

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MVPAccessProgramInfo:hQp://www.path.org/menafrivac/advancing-research.phphQp://www.meningvax.org/

Email:meningi0sresearch@path.org