Strategizing a Cure for Persistent Hepatitis B via TherVacB's efforts
The TherVacB project, a European research initiative, has made a significant stride in the fight against chronic Hepatitis B with the initiation of a multi-centre phase 1b/2a clinical trial. This study, starting in June 2025, aims to evaluate the safety, tolerability, and immune efficacy of the TherVacB therapeutic vaccine in patients with chronic HBV infection who are already on standard antiviral therapy [1][2][4].
Key milestones and features of the TherVacB project include a successful phase 1a trial in healthy volunteers, which demonstrated a favourable safety profile and the desired immune responses [1][2]. The phase 1b/2a trial is being conducted across multiple clinical sites in Germany, Italy, Spain, England, and Tanzania, involving patients with chronic HBV infection [4].
The TherVacB vaccine employs a heterologous prime-boost immunization strategy. This strategy involves priming with specifically assembled protein antigens and boosting with a viral vector (Modified Vaccinia Ankara, MVA) to generate both antibody production and robust virus-specific T-cell responses [1][2]. The vaccine approach is designed to overcome HBV-specific immune tolerance and restore antiviral B-cell and T-cell responses, with the potential to control or eliminate the virus [1][3].
Preclinical studies, including immunotoxicity evaluations in transgenic HBV mouse models, have shown no immunotoxic effects, supporting the advancement into patient trials [3]. Prof. Dr. Ulrike Protzer, the project coordinator, emphasizes that this vaccine is an immune therapy rather than a traditional vaccine and is part of a broader strategy including prophylactic vaccination and screening to help eliminate hepatitis B globally [1][2].
As the TherVacB project moves forward, it aligns with international elimination goals, including the United Nations Sustainable Development Goal 3.3 (SDG 3.3) to combat viral hepatitis by 2030. The project is funded by the EU and involves 17 partners from five European countries and Tanzania, with the TherVacB consortium including academic institutions, university hospitals, public research institutions, SMEs, and consulting companies [2].
The project's website (www.thervacb.eu/de) and a clinical trial listing on clinicaltrials.gov (NCT06513286) provide more information. The TherVacB project can also be followed on social media platforms such as Twitter (@TherVacB_EU), BlueSky (thervacb-eu.bsky.social), and YouTube (www.youtube.com/@TherVacB) [2].
It is important to note that results from the ongoing phase 1b/2a trial are still pending, so efficacy and long-term outcomes remain to be established. If successful, the first therapeutic vaccine could achieve a functional cure, a goal not reached by current antiviral therapies. This could significantly impact global treatment strategies, particularly in low- and middle-income countries.
References: [1] TherVacB Project Website. (n.d.). Retrieved from www.thervacb.eu/de [2] ClinicalTrials.gov. (n.d.). TherVacB Study. Retrieved from clinicaltrials.gov/ct2/show/NCT06513286 [3] Helmholtz Zentrum München. (2022, July 11). TherVacB: First clinical trial with novel immunotherapeutic approach against chronic hepatitis B starts. ScienceDaily. Retrieved June 25, 2023, from www.sciencedaily.com/releases/2022/07/220711132654.htm [4] TherVacB Project. (2023, June 25). TherVacB project initiates clinical trial to develop a curative therapy for chronic hepatitis B. PR Newswire. Retrieved June 25, 2023, from www.prnewswire.com/news-releases/thervacb-project-initiates-clinical-trial-to-develop-a-curative-therapy-for-chronic-hepatitis-b-301610075.html
- The TherVacB project, a European research initiative, aims to evaluate the safety and effectiveness of a novel immunotherapeutic vaccine in the treatment of chronic Hepatitis B, focusing on medical-conditions related to chronic diseases, specifically in the health-and-wellness domain.
- By employing a heterologous prime-boost immunization strategy for chronic HBV infection, the TherVacB project seeks to overcome immune tolerance and potentially control or eliminate the virus, contributing significantly to the medical-conditions sector and global health-and-wellness efforts.
