{"id":13111,"date":"2025-07-22T08:01:44","date_gmt":"2025-07-22T07:01:44","guid":{"rendered":"https:\/\/www.thervacb.eu\/?p=13111"},"modified":"2025-07-22T09:56:33","modified_gmt":"2025-07-22T08:56:33","slug":"thervacb-project-begins-patient-trial-to-advance-curative-strategy-for-chronic-hepatitis-b","status":"publish","type":"post","link":"https:\/\/www.thervacb.eu\/fr\/thervacb-project-begins-patient-trial-to-advance-curative-strategy-for-chronic-hepatitis-b\/","title":{"rendered":"TherVacB Project Begins Patient Trial to Advance Curative Strategy for Chronic Hepatitis B"},"content":{"rendered":"

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Munich, 22 July 2025:<\/strong><\/em> Chronic hepatitis B virus<\/strong> (HBV) infection remains a significant global health concern, affecting an estimated 254 million people worldwide and contributing to over one million deaths each year through liver failure and liver cancer. While current antiviral therapies can suppress viral replication, they do not eliminate the virus and often require lifelong treatment. There is an urgent need for accessible curative strategies that can relieve the long-term medical and economic burden.<\/p>\n

The TherVacB project<\/strong>, a European research initiative coordinated by Helmholtz Munich, has now reached a major milestone with the launch of its clinical trial in patients<\/strong>. Building on over a decade of research, the project aims to deliver a novel, affordable, and curative immunotherapeutic approach<\/strong> to chronic hepatitis B. This integrated approach spans basic research, preclinical and clinical development, and is supported by tools such as a European HBV Patient Registry and inclusive outreach strategies\u2014informed by ethical guidance on the use of social media-based recruitment\u2014to help reach individuals not yet engaged in regular medical care. A dedicated clinical site in Tanzania contributes to building local capacity for HBV diagnosis and treatment, while multilingual communication ensures that project updates and educational content are accessible to communities across the globe.<\/p>\n

TherVacB\u2019s milestone in patient recruitment follows a successful phase 1a trial in healthy volunteers, in which the TherVacB vaccine candidate demonstrated a favourable safety profile and triggered the desired immune responses. The TherVacB EU project consortium now advances to a multi-centre phase 1b\/2a trial<\/strong>, evaluating the safety, tolerability, and immune efficacy of the vaccine in patients with chronic HBV infection<\/strong> who are receiving standard antiviral therapy.<\/p>\n

\u201cThis transition into patient trials is a major milestone,\u201d<\/em> said Prof. Dr. Ulrike Protzer, Project Coordinator of TherVacB and Director of the Institute of Virology at Helmholtz Munich and the Technical University of Munich. \u201cTherVacB represents more than just a vaccine\u2014it\u2019s an immune therapy aiming to empower the immune system to control or even eliminate the virus. This approach, when combined with prophylactic vaccination, screening, and awareness, supports the global goal of eliminating hepatitis B as a public health threat.\u201d<\/em><\/p>\n

A Precision-Engineered Immunotherapeutic Approach<\/strong><\/h2>\n

At the core of the TherVacB approach is a heterologous prime-boost vaccination regimen<\/strong> that uses specifically assembled protein antigens for priming followed by a viral vector (MVA) boost, designed to induce both antibody production and strong virus-specific T-cell responses. This approach is intended to be effective against more than 95% of global HBV strains and aims to address the different epidemiological patterns of hepatitis B found across continents.<\/p>\n

Trial Design and Patient Impact<\/strong><\/h2>\n

The clinical trial, which began in June 2025<\/strong>, is sponsored by LMU University Hospital Munich. It is enrolling a total of 81 patients<\/strong> across multiple international clinical sites in Germany, Italy, Spain, the United Kingdom, and Tanzania<\/strong>. The study is designed in two sequential phases:<\/p>\n