Issue Number 1

Welcome to the first PEVIA Newsletter DearReader,

Wewould like towelcomeyouto the first issueof theNewsletterof thePEVIAprojecton“thedevelopmentofan innovativepan-Ebolavaccineandnewfunctionalanalysistools”fundedIMI2JU. The Newsletter will give you an update on our activities and our progress but also on thepublicationsandupcomingeventsrelatedtoPEVIAproject.

Pleasedon't hesitate todisseminate thisNewsletter to anyonewho could alsobe interested inreadingit. IfyouwanttoreceivethePEVIAe-newsletter inthefuture,youcansubscribeonourwebsiteviathelinkbelow.Ifyou'renotinterestedinreceivingourNewsletteranymore,youcanunsubscribeviatheunsubscribebuttonattheendofthisnewsletter.

WehopeyouwillenjoythisNewsletterandlookforwardtoyourvisitonPEVIAwebsiteformoreinformationandupdatesontheprogram.

Bestwishes,

ProjectManagementTeamPrOdileLaunay(AP-HP/CIC)ProjectCoordinator

DrAhmedBouzidi&DrJérômeKerzerho(VAXEAL)ScientificCoordinators

SubscribetoPEVIAnewsletter

PEVIA Project Information

PEVIA-Pan-EbolaVaccineInnovativeApproach-isacollaborativeresearchprogrammeaimingtodevelop and to bring to the clinics an innovative pan-Ebola vaccine, safe and effective againstmultipleEbolavirusstrainsandeasetoproduceanddeployinendemicregions.

TheoverallobjectiveofPEVIAistobringthisnewpan-Ebolavaccineuptoastagereadyfortestingin an outbreak setting by comprehensively analyzing their immunological and safety profile inhumanusingcutting-edgetechnologies.

PeVIA Newsletter September 2018

Theprojectalsoaddressesthedevelopmentinnovativefunctionalanalysistoolstoacceleratethedevelopment of new vaccine candidates against Ebola virus and Filovirus as well as noveldiagnosticteststhatcanbereadilydeployedinthefield.

PEVIAprojectwillhaveasignificantimpactonglobalhealth,bothattheindividualandthepublichealth levels,andwill increasethereadiness torespondto futureoutbreaksofEbolaandotherfiloviralhaemorrhagic

PEVIAisa6yearsprojectstartedinJune2017andfundedbytheInnovativeMedicineInitiative2JointUndertaking(IMI2JU).

ReadmoreonthePEVIAwebsite

PEVIA Consortium

PEVIA is a public-private consortium made up of 13 partners involving 3 European small andmediumenterprises(SMEs),andexpertsfrom10academic institutions, includingscientistsfromtwoBSL-4 laboratoriesand fourclinical centers (2 inEuropeand2 inAfrica).PEVIAConsortiumbrings togethermost advanced competences, and state-of-the art facilities and technologies tofacilitateEbolavaccinedevelopmentandtobringituptoastagereadyfortestinginanoutbreaksetting(PhaseIainEuropeandPhaseIbinAfrica).

The PEVIA project is coordinated by Assistance Publique -Hôpitaux de Paris (AP-HP), a publichealth establishment, and the Scientific Coordination is lead byVAXEALResearch, an EuropeanSME.

ReadmoreaboutthePEVIAConsortium

PEVIA Kick-off Meeting

PEVIAhelditsKick-offmeetingon4thOctober2017,attheMuséedesMoulagesoftheHôpitalSaintLouisin Paris, France. Thirty-eight (38) participants from 6 countries representing all the organizationsparticipatinginPEVIAandallworkpackagesweregatheredtodiscussthecomingsixyear’swork.

Plenarysessionsforoverview,andadministrativeandfinancialaspectsoftheprojecttookplace.Theten(10)workpackages(WP)werealsopresentedbytheWPleaderswitheachinvolvedpartner,anddiscussedinawarmproductiveenvironment.Finally,thenextstepsfortheupcoming8monthswerepresentedanddiscussedinaplenarywrap-upsession.

Themeetingwasanoutstandingstarttotheproject,inparticularbyreinforcingthecohesionofthegroup,whichisofgreatimportanceforthesuccessoftheproject.

PEVIA Brochure

ThePEVIABrochurehasbeendevelopedby theCoordinationTeamtobroadlycommunicateonPEVIAactivities,objectives,andkeyconcepts.DownloadPEVIABrochure

TRANSVAC2 Infrastructure Access

PEVIA consortium synergizes with the H2020 fundedTRANSVAC2 infrastructure project for Vaccine DevelopmentServices.

Under the leadofDr FabienneAnjuere (IPMC/CNRS),PEVIAconsortium applied to TRANSVAC2 Call 1710-01 fortranslationalaccesstotheAdjuvantandformulationservicesproposed by the Vaccine Formulation Laboratory of theUniversityofLausanne(UNIL).

TRANSVACisanewinfrastructureproject-fundedbytheEuropeanCommissioninthecontextofHorizon2020-thataimstoacceleratethedevelopmentofeffectivevaccinesurgentlyneededtoaddress European and global health challengeswith the ultimate goal to build an efficient andsustainable collaboration of experts and facilities to catalyze vaccine research in Europe. In

Pan-Ebola Vaccine Innovative ApproachPeVIA The WHO has announced that Ebola is now one of the mostdangerousdiseasestothreatenthehumanraceonaglobalscale.Ebola virus (EBOV) is a member of Filoviridae family of viruses,whichhavebeenassociatedwith largeoutbreaksofhemorrhagicfever in human and nonhuman primates with high case fatality.The severity of the recent outbreak of Ebola inWestern Africa,caused by the Zaire Ebola virus (ZEBOV), has reached historicproportions and underscores the vulnerability of populationsworldwidetopathogens.Ebola vaccines are urgently needed Despitehugeefforts, therearecurrentlynovaccinesorantiviraldrugsapproved forpreventionor treatmentof Ebola infectionsinhumans.However,theseverityoftherecentEbolaoutbreakinWestAfrica,causedbyZaireEbolavirus(ZEBOV),andfailureofthehealth care system to contain the infection rates inWestAfrica,point out the need for the rapid development of safe andeffectivepreventivevaccines. Suchvaccines,effectiveagainstallmainEBOVstrainsandthatcanbereadilyproducedanddeployedin the field,areneeded toprotectpeople inendemic regions inaneventofanoutbreakbutalso toprotecthealthcareworkerscaring forEbolapatients,whoareat thehighest riskof infectionevenbeforeanoutbreakcanbeidentified.PEVIA Objectives

TheIMI-fundedPEVIAprojectaimstodevelopandtobringtotheclinics(PhaseIainEuropeandPhaseIbinAfrica)innovativepan-Ebola preventive vaccines, safe and effective against multipleEbola virus strains and readily deployable in endemic regions.PEVIA’scutting-edgestrategyisbasedontwocomplementaryandsynergistic approaches based on the Ebola surface glycoprotein(GP) and nucleoprotein (NP) from the Zaire Ebola virus (ZEBOV).Thisincludesi/anative-likerecombinantEbolaGP(recGP)-basedvaccinetogeneraterobustanti-EBOVneutralizingantibodiesandlong-termhumoralresponses,andii/aLongSyntheticPeptides

(LSP)-based vaccine containing multiple overlapping CD4+ andCD8+T-cellepitopesderivedfromZEbolaGPandNP,togeneratestrongandlong-lastingcellularresponses.

PEVIA’s strategyaims to improvevaccineefficacyagainstvariousstrainsofamutatingvirustogivealonglastingprotectionagainstmultiple exposures to Ebola virus. PEVIA’s vaccines are expectedto overcome the issues of stability, storage and deployment inendemic regions, making them fully adapted for large-scalevaccinationintheeventofafutureoutbreak,forpeopleathigh-risk early post-exposure to the virus as well as the healthcareworkersandvolunteerscaringforEbolapatients.

PEVIA consortium also aims to provide innovative functionalanalysis tools and in vitromethods to helpwith preclinical andclinicaldevelopmentofnewEbolaandFilovirusvaccinecandidatesaswell as novel diagnostic tests that can be readily deployed inthefield.PEVIA Impacts

PEVIA’s innovative approach and functional analysis tools aim toexpand the scientific knowledge regarding the immunologicalcorrelateofprotectionagainstEbolainfectionsinhuman,andaimtoincreasethereadinesstorespondtofutureoutbreaksofEbolaandotherfiloviralhemorrhagicfevers.PEVIAprojectthusexpectstohaveasignificantimpactonglobalhealth,bothattheindividualand thepublic health levels. The knowledge accumulatedby theconsortiummayfurtherbeextendedtodevelopeffectivevaccinesagainst other virus infections. Finally, PEVIA technologieswill bedisseminated worldwide for a better management of Ebolainfections andwill help to strengthen European competitivenessand industrial leadership in the field of vaccine research andinnovation.

PEVIA project details

Fullprojecttitle:Pan-EBOLAVaccineInnovativeApproachProjectNumber:116088Startdate:01/06/2017Duration:72monthsTotalbudget:€11.7millionProjectcoordinator:AP-HP(PrO.Launay)Scientificcoordinator:VAXEAL(DrA.Bouzidi,DrJ.Kerzerho)Partners:13from6countriesProjectwebsite:www.PEVIA-Ebola.eu

Design&LabScaleSynthesisofVaccineCandidates

VaccineFormulation&Pre-clinicalProof-of-ConceptStudies

Scale-up,cGMPmanufacturing&Pharmaco-toxicologicalstudies

Developm

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analysisto

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ClinicalTrials(PhaseIainEurope&PhaseIbinAfrica)

Project Organization

ThisprojecthasreceivedfundingfromtheInnovativeMedicinesInitiative2JointUndertakingundergrantagreementNo116088.ThisJointUndertakingreceivessupportfromtheEuropeanUnion’sHorizon2020researchandinnovationprogramme,andEFPIA.www.imi.europa.eu

Pan-Ebola Vaccine Innovative Approach PeVIA

VAXEALResearch–Francewww.vaxeal.netExcellGeneSA–Switzerlandwww.excellgene.comOligovaxSAS–Francewww.oligovax.com

TheAssistancePublique-HôpitauxdeParis(AP-HP,CICCochinPasteur1417)–Francewww.aphp.frLeCommissariatàl'EnergieAtomiqueetauxénergiesalternatives(CEA)–Francewww.cea.frCentreHospitalierUniversitaireVaudois(CHUV)–Switzerlandwww.chuv.chCentreNationalDeLaRechercheScientifique(CNRS)–Francewww.cnrs.frBernhard-Nocht-InstituteforTropicalMedicine(BNITM)–Germanywww.bnitm.deCentreHospitalierRegionaletUniversitairedeLille(CHRULille)–Francewww.chru-lille.fr

IfakaraHealthInstitute(IHI)–UnitedRepublicofTanzaniawww.ihi.or.tzIstitutoNazionaleMalattieInfettiveLazzaroSpallanzani(INMI)–Italywww.inmi.itUniversitéD'abomey-Calavi–Beninwww.uac.bjIstitutoSuperioreDiSanita(ISS)–Italywww.iss.it

Smallandmedium-sizedenterprises(SMEs)

Project Coordinator

PrOdileLaunayAP-HP,CICCochinPasteur141727RueduFaubourgStJacques

75679,ParisFrance

odile.launay@aphp.fr 

Scientific Coordinator

DrAhmedBouzidi&DrJérômeKerzerhoVAXEALResearch

4RuePierreFonataine91058,Every

Francejkerzerho@vaxeal.net

FINANCINGIMIfunding €6.2millionVAXEAL €6.1million(AssociatedmembertoEFPIA)Othercontributions(SERI) €5.4millionTotalprojectcost €17.7million

www.imi.europa.eu

February 2018, the TRANSVAC2 User Selection Panel (USP) and Steering Committee (SC) haveapprovedPEVIAapplication(Pr-EBOV-GP-180205),andtheprojectstartedinMay2018.

PEVIA-TRANSVAC2 project aims to identify the optimal adjuvant formulation(s) of near-nativerecombinant ZEBOLA GP variants (rec-GP), developed by the Swiss partner ExcellGene SA, toinduce a protective and long-lasting humoral and cellular immune responses against Ebolaglycoprotein(GP),bothfundamentaltoprotectagainsttheEbolavirus.Thisprojectwillenabletoprepare high quality adjuvanted formulations of two GP candidates. The prepared andcharacterized formulations will then be tested – as a separate activity – to evaluate theimmunogenicity and protective effect against lethal Ebola challenge of the GP candidates inrelevantmousemodels.

Webelievethatourprotein-basedcandidateshaveagreatpotentialtobeeffectiveagainstEbolavirus, and that the best support in terms of adjuvant selection and formulation is needed toproducesolidresultsandquickprogresstowardsclinicalphases.

Upcoming events

Upcoming interesting conferences • 5thEuropeanCongressofImmunology-ECI2018

2-5September2018–Amsterdam,NetherlandsFormoreinformation,clickhere

• 12thVaccineCongress

16-19September2018–Budapest,HungaryFormoreinformation,clickhere

• FramingtheResponsetoEmergingVirusInfections

14-18October2018–HongKongFormoreinformation,clickhere

• MolecularApproachestoVaccinesandImmuneMonitoring

10-14February2019–Keystone,Colorado,USAFormoreinformation,clickhere

• WorldVaccineCongressEurope

29-31October2018–Lisbon,PortugalFormoreinformation,clickhere

• ICVID2019-21thInternationalConferenceonVirologyandInfectiousDiseases

14-15January2019–Zurich,SwitzerlandFormoreinformation,clickhere

• 2019AnnualConferenceonVaccinologyResearch

3-5April2019–HyattRegencyBaltimoreInnerHarbor,Baltimore,MDFormoreinformation,clickhere

• EuropeanCongressofClinicalMicrobiologyandInfectiousDiseases-ECCMID201913-16April2019–Amsterdam,NetherlandsFormoreinformation,clickhere

• ASMmicrobe2019

20-24June2019–SanFrancisco,USAFormoreinformation,clickhere

• 9thCongressofEuropeanmicrobiologists-FEMS2019

7-11July2019–Glasgow,ScotlandFormoreinformation,clickhere

• 17thInternationalCongressofImmunology-IUIS2019

19-23October2019–Beijing,ChinaFormoreinformation,clickhere

Upcoming interesting Courses • ClinicalImmunologyTrainingCourse

2September2018–Amsterdam,NetherlandsFormoreinformation,clickhere

• TheAdvancedCourseonMucosalImmunology

22-27October2018–Córdoba,ArgentinaFormoreinformation,clickhere

• ADVAC-AdvancedCourseofVaccinology

13-24May2019–Veyrier-du-Lac(FrenchAlps),Geneva,SwitzerlandFormoreinformation,clickhere

Relevant Publications EbolaVirusDiseaseinMicewithTransplantedHumanHematopoieticStemCellsAnjaLüdtke,LisaOestereich,PaulaRuibal,StephanieWurr,ElisaPallasch,SabrinaBockholt,WingHangIp,ToniRieger,SergioGómez-Medina,CarolStocking,EstefaníaRodríguez,StephanGünther,CésarMuñoz-Fontela;J.Virol.89,4700–4(2015).https://www-ncbi-nlm-nih-gov.gate2.inist.fr/pmc/articles/PMC4442348/pdf/zjv4700.pdfChimeric Mice with Competent Hematopoietic Immunity Reproduce Key Features of SevereLassaFeverLisa Oestereich, Anja Lüdtke, Paula Ruibal, Elisa Pallasch, Romy Kerber, Toni Rieger, StephanieWurr,SabrinaBockholt,JoséV.Pérez-Girón,SusanneKrasemann,StephanGünther,CésarMuñoz-Fontela;PLOSPathog.12,e1005656(2016)https://www-ncbi-nlm-nih-gov.gate2.inist.fr/pmc/articles/PMC4871546/pdf/ppat.1005656.pdf

FieldAssessmentoftheNewRapidDiagnosticTestEbolaeZYSCREEN®F.Gallais,F.Gay-Andrieu,V.Picot,N.Magassouba,S.Mély,C.N.Peyrefitte,L.Bellanger;Bull.Soc.Pathol.Exot.110:38-48(2017)https://link-springer-com.gate2.inist.fr/content/pdf/10.1007%2Fs13149-016-0540-z.pdf

PEVIA Contacts ThisprojecthasreceivedfundingfromtheInnovativeMedicinesInitiative2JointUndertakingundergrantagreementNo116088.This JointUndertaking receives support from theEuropeanUnion’sHorizon2020researchandinnovationprogramme,andEFPIA.www.imi.europa.eu

EMAIL

http://www.PEVIA-Ebola.euContact@PEVIA.org

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