Project description DEENESFRITPL Novel therapeutic vaccine to cure hepatitis B Spontaneous resolution of hepatitis b virus (HBV) infection is characterised by neutralising antibodies and HBV-specific T cell responses, elements which are lacking in chronic HBV infection. The EU-funded TherVacB project aims to overcome immune tolerance in chronic HBV infection and the virus’s resistance to cure. The interdisciplinary consortium will employ a heterologous prime-boost therapeutic vaccination scheme with proven efficacy in preclinical models of hepatitis B to target and activate B and T cell responses; thereby, TherVacB hopes to produce vaccine components and prepare a first-in-human application. To provide a clinical proof of concept of the therapeutic hepatitis B vaccine in patients with chronic hepatitis B, the consortium will establish a patient registry and perform a multicentre phase Ib/IIa clinical trial of the vaccine's safety and potency to induce immune control of chronic HBV infection. Show the project objective Hide the project objective Objective Experts in virology, immunology and clinical hepatitis B patient care with an excellent research and translational track record in hepatitis B virus (HBV)-host interaction form the interdisciplinary TherVacB consortium. They jointly tackle the major challenges in HBV therapy – the virus’s resistance to cure. TherVacB aims at breaking immune tolerance in chronic HBV infection and achieving HBV cure. Occurrence of neutralizing antibodies and HBV-specific T cell responses characterize spontaneous resolution of HBV infection that are lacking in chronic infection. We will use our IP-protected heterologous prime-boost therapeutic vaccination scheme with proven efficacy in preclinical models of hepatitis B to target and activate B and T cell responses. Two protein prime injections with clinically approved, adjuvanted particulate HBV S and core protein antigens shall induce neutralizing antibodies and prime T cells that are boosted with an MVA vector expressing HBV core, S, L and polymerase antigens covering >95% of HBV found worldwide. Having secured significant funding and partnerships to obtain GMP-produced vaccine components and to prepare a first-in-human application, TherVacB aims at a clinical proof-of-concept of the therapeutic hepatitis B vaccine in patients with chronic hepatitis B. The consortium will establish a patient registry and perform a multi-center phase Ib/IIa clinical trial that aims at proving safety of the therapeutic vaccine and inducing immune control of chronic HBV infection. One study arm will be realized in Tanzania to build up local capacity, because Africa carries a large burden of HBV infection but lacks diagnostic and therapeutic options. An innovative immune monitoring will quantify HBV-specific immunity and define novel biomarkers to predict treatment response. Finally an ethical and an empirical study will evaluate the recruitment of patients by social media which is very effective for infectious diseases that tend to stigmatize patients Fields of science medical and health scienceshealth sciencesinfectious diseasesDNA viruseshepatitis B Keywords Viral hepatitis HBV cure Hepatitis B patient stratification patient cohorts clinical trial therapeutic vaccine adjuvant patient recruitment capacity building Africa Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) SC1-BHC-14-2019 - Stratified host-directed approaches to improve prevention, treatment and/or cure of infectious diseases Call for proposal H2020-SC1-BHC-2018-2020 See other projects for this call Sub call H2020-SC1-2019-Two-Stage-RTD Funding Scheme RIA - Research and Innovation action Coordinator HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH Net EU contribution € 4 049 761,25 Address INGOLSTADTER LANDSTRASSE 1 85764 Neuherberg Germany See on map Region Bayern Oberbayern München, Landkreis Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 4 049 761,25 Participants (18) Sort alphabetically Sort by Net EU contribution Expand all Collapse all KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN Germany Net EU contribution € 1 394 787,50 Address ISMANINGER STRASSE 22 81675 Muenchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 394 787,50 NATIONAL INSTITUTE FOR MEDICAL RESEARCH Tanzania Net EU contribution € 489 287,50 Address SOKOINE LUTHULI DRIVE OCEAN ROAD 255 DAR ES SALAAM See on map Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 489 287,50 UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF Germany Net EU contribution € 209 350,00 Address Martinistrasse 52 20251 Hamburg See on map Region Hamburg Hamburg Hamburg Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 209 350,00 FUNDACIO DE RECERCA CLINIC BARCELONA-INSTITUT D INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER Spain Net EU contribution € 110 000,00 Address CARRER ROSSELLO 149 08036 Barcelona See on map Region Este Cataluña Barcelona Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 153 750,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. HOSPITAL CLINIC DE BARCELONA Spain Net EU contribution € 43 750,00 Address CALLE VILLARROEL 170 08036 Barcelona See on map Region Este Cataluña Barcelona Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 43 750,00 AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA Italy Net EU contribution € 714 893,75 Address VIA GRAMSCI 14 43100 Parma See on map Region Nord-Est Emilia-Romagna Parma Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 714 893,75 MEDIZINISCHE HOCHSCHULE HANNOVER Germany Net EU contribution € 131 125,00 Address Carl-Neuberg-Strasse 1 30625 Hannover See on map Region Niedersachsen Hannover Region Hannover Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 131 125,00 UNIVERSITY COLLEGE LONDON United Kingdom Net EU contribution € 536 023,75 Address GOWER STREET WC1E 6BT London See on map Region London Inner London — West Camden and City of London Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 536 023,75 CTC NORTH GMBH & CO KG Participation ended Germany Net EU contribution € 19 965,06 Address MARTINISTRASSE 64 20251 Hamburg See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Hamburg Hamburg Hamburg Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 19 965,06 HELMHOLTZ-ZENTRUM FUR INFEKTIONSFORSCHUNG GMBH Germany Net EU contribution € 146 500,00 Address INHOFFENSTRASSE 7 38124 Braunschweig See on map Region Niedersachsen Braunschweig Braunschweig, Kreisfreie Stadt Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 146 500,00 LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN Germany Net EU contribution € 675 380,00 Address GESCHWISTER SCHOLL PLATZ 1 80539 Muenchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 675 380,00 UNIVERSITAET LEIPZIG Germany Net EU contribution € 142 900,00 Address RITTERSTRASSE 26 04109 Leipzig See on map Region Sachsen Leipzig Leipzig Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 142 900,00 BARTS AND THE LONDON NHS TRUST United Kingdom Net EU contribution € 104 500,00 Address PRESCOT STREET 9 E1 8PR London See on map Region London Inner London — East Tower Hamlets Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 104 500,00 ARTTIC Participation ended France Net EU contribution € 35 323,14 Address 39 RUE DES MATHURINS 75008 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 35 323,14 ROYAL FREE LONDON NHS FOUNDATION TRUST United Kingdom Net EU contribution € 100 000,00 Address POND STREET HAMPSTEAD NW3 2QG London See on map Region London Inner London — West Camden and City of London Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 100 000,00 TECHNISCHE UNIVERSITAET MUENCHEN Germany Net EU contribution € 191 556,25 Address Arcisstrasse 21 80333 Muenchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 191 556,25 ARTTIC INNOVATION GMBH Germany Net EU contribution € 237 423,11 Address OSKAR-VON-MILLER-RING 29 80333 Munchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 237 423,11 MONIPOL DEUTSCHLAND GMBH Germany Net EU contribution € 1 093 159,90 Address RONCALLISTRASSE 39 53123 BONN See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 093 159,90
