Towards a cure for hepatitis B
The EU-funded TherVacB(opens in new window) project has begun a clinical trial for a newly designed vaccine for the hepatitis B virus (HBV). The trial is a key step in the project’s efforts to deliver an affordable and curative immunotherapeutic approach to chronic hepatitis B infection. About 254 million people across the globe live with chronic hepatitis B infection, with 1.2 million new infections recorded each year. Chronic HBV infection can cause liver failure and liver cancer, which in 2022 led to an estimated 1.1 million deaths. Although today’s antiviral therapies can stop the virus from reproducing, they do not eliminate the virus and often require lifelong treatment.
Building on success
To reach the clinical trial stage, TherVacB first carried out a phase 1a trial in healthy volunteers to evaluate the vaccine’s safety and gather preliminary information on the immune responses triggered. The early-phase trial’s success has now resulted in the launch of the multi-centre phase 1b/2a trial. Here, the purpose is to test the safety, tolerability and immune efficacy of the vaccine in patients with chronic HBV infection who are receiving standard antiviral therapy. “This transition into patient trials is a major milestone,” remarks Prof. Ulrike Protzer of TherVacB project coordinator Helmholtz Munich and project partner Technical University of Munich in a ‘Presseportal’ news item(opens in new window). “TherVacB represents more than just a vaccine – it’s 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.” The clinical trial began in June 2025 and is enrolling a total of 81 patients from clinics in Germany, Italy, Spain, Tanzania and the United Kingdom. The trial will have two sequential phases, phase 1b and phase 2a. In the first phase, patients will be given ascending doses of the vaccine to determine the safest and most effective regimen. In the second phase, the optimal dose established in phase 1b will be tested in more patients to confirm safety and assess the vaccine’s ability to inhibit viral replication, reduce viral load and improve health outcomes in chronically infected patients. As reported in the news item, the TherVacB vaccination regimen “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.” The trial is a key step towards a functional cure for chronic hepatitis B, something today’s treatments do not achieve. If successful, the vaccine could ease the global burden of disease, stop the progression to liver damage and cancer, and reduce deaths linked to hepatitis B.
Raising awareness
To mark World Hepatitis Day 2025 (28 July), TherVacB (THERVACB: A THERAPEUTIC VACCINE TO CURE HEPATITIS B) and another EU-funded project, D‑SOLVE, released the fifth video in their joint campaign to raise awareness about HBV and the hepatitis D virus (HDV), which only occurs in people who have hepatitis B. The ‘Insights on HDV and HBV’ video series(opens in new window) answers important questions raised in patient communities about diagnosis, co-infection, treatment needs and research progress. For more information, please see: TherVacB project website(opens in new window)
