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THERVACB: A THERAPEUTIC VACCINE TO CURE HEPATITIS B

Project information

Grant agreement ID: 848223

Status

Ongoing project

  • Start date

    1 January 2020

  • End date

    31 December 2024

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 10 425 686,25

  • EU contribution

    € 10 425 686,25

Coordinated by:

HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH

Germany

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
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Coordinator

HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH

Address

Ingolstadter Landstrasse 1
85764 Neuherberg

Germany

Activity type

Research Organisations

EU Contribution

€ 4 049 761,25

Participants (15)

KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN

Germany

EU Contribution

€ 1 394 787,50

NATIONAL INSTITUTE FOR MEDICAL RESEARCH

Tanzania

EU Contribution

€ 489 287,50

UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF

Germany

EU Contribution

€ 209 350

FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA

Spain

EU Contribution

€ 153 750

AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA

Italy

EU Contribution

€ 714 893,75

MEDIZINISCHE HOCHSCHULE HANNOVER

Germany

EU Contribution

€ 131 125

UNIVERSITY COLLEGE LONDON

United Kingdom

EU Contribution

€ 536 023,75

CTC NORTH GMBH & CO KG

Germany

EU Contribution

€ 1 113 125

HELMHOLTZ-ZENTRUM FUR INFEKTIONSFORSCHUNG GMBH

Germany

EU Contribution

€ 146 500

LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN

Germany

EU Contribution

€ 675 380

UNIVERSITAET LEIPZIG

Germany

EU Contribution

€ 142 900

BARTS AND THE LONDON NHS TRUST

United Kingdom

EU Contribution

€ 104 500

ARTTIC

France

EU Contribution

€ 272 746,25

ROYAL FREE LONDON NHS FOUNDATION TRUST

United Kingdom

EU Contribution

€ 100 000

TECHNISCHE UNIVERSITAET MUENCHEN

Germany

EU Contribution

€ 191 556,25

Project information

Grant agreement ID: 848223

Status

Ongoing project

  • Start date

    1 January 2020

  • End date

    31 December 2024

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 10 425 686,25

  • EU contribution

    € 10 425 686,25

Coordinated by:

HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH

Germany