Project description
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.
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 (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
- natural sciences biological sciences microbiology virology
- medical and health sciences health sciences infectious diseases DNA viruses hepatitis B
- natural sciences biological sciences biochemistry biomolecules proteins
- medical and health sciences basic medicine immunology
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs vaccines
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
MAIN PROGRAMME
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H2020-EU.3.1.3. - Treating and managing disease
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
RIA - Research and Innovation action
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-SC1-BHC-2018-2020
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
85764 Neuherberg
Germany
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.