Innovative Treatment Approach for Persistent Hepatitis B: TherVacB
In a significant breakthrough for the global fight against chronic hepatitis B, the TherVacB project has commenced a multi-centre phase 1b/2a patient trial. The European research initiative, funded by the Horizon 2020 programme, aims to deliver a novel, affordable, and curative immunotherapeutic approach to chronic hepatitis B.
The TherVacB project, led by Helmholtz Zentrum München, brings together leading expertise in virology, immunology, and clinical vaccine development from 17 partners across five European countries and Tanzania. The consortium includes academic institutions, university hospitals, public health research centres, SMEs, and consultancies, such as PNO Innovation Germany, who provide support in public funding, R&I project management, communication, and stakeholder engagement.
The phase 1b/2a trial started enrolling patients in June 2025, with a planned total of 81 participants who have chronic HBV infection and are undergoing standard antiviral therapy. This trial aims to evaluate the safety, tolerability, and immune efficacy of the TherVacB vaccine candidate in patients with existing HBV infection.
The TherVacB approach employs a heterologous prime-boost vaccination regimen, using protein antigens for priming followed by a viral vector (Modified Vaccinia Ankara - MVA) boost. This strategy is designed to induce strong antibody and virus-specific T-cell immune responses, targeting more than 95% of global HBV strains and addressing different epidemiological forms of hepatitis B worldwide.
The project has been under development for over a decade, with preclinical studies, including immunotoxicity assessments in transgenic mouse models, showing no significant adverse effects. These findings support the vaccine’s safety profile as it transitions into clinical trials in patients.
According to Prof. Dr. Ulrike Protzer, project coordinator and inventor of TherVacB, this immunotherapeutic vaccine aims not merely to suppress HBV but to empower the immune system to control or potentially eliminate the virus, representing an important step toward a curative treatment that could help achieve the global goal of hepatitis B elimination as a public health threat.
As of July 2025, the results from the ongoing patient trial have not yet been published. However, if successful, TherVacB could become the first therapeutic vaccine to offer a functional cure for chronic hepatitis B, potentially shaping global treatment strategies, particularly in low- and middle-income countries.
The TherVacB project also addresses regulatory and societal considerations through a dedicated study and includes ethical research on social media-based patient recruitment. Multilingual outreach ensures wide access to project information for diverse populations, while the TherVacB project facilitates patient identification via the European HBV Patient Registry.
The TherVacB project aligns with global elimination efforts, including the United Nations Sustainable Development Goal (SDG) 3.3 to combat viral hepatitis by 2030. With the commencement of the patient trial, the TherVacB project is a significant stride forward in the pursuit of a cure for chronic hepatitis B.
- The TherVacB project, a significant stride in the global fight against chronic hepatitis B, is currently conducting a multi-centre phase 1b/2a trial for patients with chronic medical-conditions, such as hepatitis B.
- This European research initiative, funded by the Horizon 2020 programme, aims to deliver a novel, affordable, and curative immunotherapeutic approach to chronic hepatitis B, contributing to health-and-wellness in the management of chronic diseases like hepatitis B.
- If successful, the TherVacB vaccine candidate, employing therapies-and-treatments like a heterologous prime-boost vaccination regimen, could potentially offer a functional cure for chronic hepatitis B, shaping future treatment strategies, particularly in low- and middle-income countries.
