May 2026
Scientific Results | Clinical Development | Hepatitis B Research

New early clinical trial results support the ongoing TherVacB patient study for chronic hepatitis B.

A recent analysis published by GlobalData Healthcare and Clinical Trials Arena highlights findings from a completed first-in-human Phase Ia clinical study conducted outside the EU-funded TherVacB project.

In healthy adult volunteers, the therapeutic vaccine candidate “TherVacB” was shown to be safe, well tolerated, and capable of triggering strong immune responses. Early studies of this kind are an essential first step before evaluating new therapeutic approaches in people living with chronic hepatitis B.

These results provide important support for the ongoing TherVacB clinical study, which aims to develop a functional cure for chronic hepatitis B by helping the immune system regain control over HBV infection.

Why do these early results matter for TherVacB patients?

Chronic hepatitis B affects around 254 million people worldwide and can lead to liver cirrhosis and liver cancer. Current treatments can suppress the virus, but they rarely achieve a functional cure and often require lifelong therapy.

The TherVacB EU project is developing a therapeutic vaccine approach designed to help the immune system regain long-term control over HBV infection.

The completed Phase Ia is important because it showed for the first time that the “TherVacB” vaccine candidate could safely trigger strong immune responses in humans. These findings provide important support for the ongoing TherVacB patient study and the project’s continued clinical development pathway.

What happens next in the TherVacB patient study?

TherVacB clinical centres are actively enrolling people living with chronic hepatitis B into the ongoing Phase Ib patient study.

This study is an important next step in evaluating the TherVacB vaccine approach in people affected by chronic HBV infection. The encouraging findings from healthy volunteers are now helping guide the ongoing patient study. Researchers are now assessing safety, tolerability, and immune responses to better understand whether the vaccine approach can help patients regain immune control over the virus.

Alongside the clinical study, the TherVacB project continues its work on immune monitoring, biomarker research, patient engagement, and awareness activities to support the long-term goal of developing a functional cure for chronic hepatitis B.

Read More

• Read the full analysis by Clinical Trials Arena and GlobalData Healthcare:
  https://www.clinicaltrialsarena.com/analyst-comment/escmid-global-2026-thervacb-phase-i-data/
• Explore TherVacB scientific publications and dissemination activities:
  https://www.thervacb.eu/media-center/publications/

Every year, 1.3 million people lose their lives to hepatitis. New data from the World Health Organization shows the number of deaths is rising.

The TherVacB team is not waiting for change. Together with researchers from the D-Solve consortium and supporting partners, we take action to make change happen!

On World Hepatitis Day 2024, we are proud to introduce the “Hepatitis D: B aware” campaign and its new series of short videos “Insights on HDV and HBV” answering key questions relating to hepatitis D and B.

DZIF professor for Translational Virology, Prof. Stephan Urban, kicks off the video series to raise awareness about hepatitis D (HDV) and hepatitis B (HBV) and to empower the community. He contributes to “Insights on HDV and HBV” by discussing: “What is hepatitis D and hepatitis D Virus (HDV)?”

• Why does hepatitis D only exist together with hepatitis B?
• What is a superinfection with hepatitis D?
• What happens in the hepatitis B / D infected cell?

Researchers from the two EC-funded projects  ‘IP-cure-B – Take care of your health’ and ‘TherVacB – A therapeutic vaccine to cure Hepatitis B’ continue their collaboration to jointly tackle some of the major challenges in the therapy of viral hepatitis.

Building on a first exploratory session in summer 2023, a wider team of researchers are meeting on 5^th June 2024 for a 2^nd round of strategic discussions. The workshop is hosted by both consortia at the Congress of the European Association for the Study of the Liver (EASL) 2024 in Milano, Italy, and held at the Milano Convention Centre “Allianz MiCo” in the South Wing Level 2 meeting room “Amber 6”. 

In 2020, work on chronic hepatitis B by the research and clinical communities in the two projects had kicked-off in parallel. Funded by the European Commission under the same topic, both research teams have adopted stratified host-directed approaches to raise awareness and improve prevention, treatment and functional cure of hepatitis B.  

At EASL 2024, a larger group of IP-cure-B and TherVacB experts in virology, immunology and clinical hepatitis will engage in focused discussions on the different aspects of viral hepatitis B infection (HBV) and the HBV-mediated chronic disease that they are investigating to reduce the global health burden: 

• the therapeutic approaches,
• the clinical trials,
• virologic monitoring, immune profiling and biomarker identification &
• the TherVacB Patient Registry.

Professor Ulrike Protzer and her TherVacB team at Helmholtz Munich and TUM have been honoured with the prestigious Bavarian m4 Award 2023. Key members of the Helmholtz Munich and TUM team for TherVacB proudly received the m4 Award on 24 October 2023 at Munich Residence (surrounded by Bio^M representatives on the picture are from left to right Dr. Anna Kosinska, Dr. Marian Wiegand, Prof. Dr. Ulrike Protzer, Romina Bester, Dr. Frank Thiele, Prof. Dr. Percy Knolle).

The prize acknowledges their promising therapeutic hepatitis B vaccine that is able to reactivate antiviral immune responses. Preclinical models have already demonstrated its effectiveness in curing chronic infection, initial clinical trials will start soon. This includes a first-in-human study in healthy individuals without HBV infection or hepatitis B immunization. Together with the TherVacB project team, Ulrike Protzer’s  ground-breaking research initiative will take the developed TherVacB vaccine to the next level in a clinical trial involving hepatitis B patients.  

For those suffering from chronic hepatitis B, no curative treatment option exists until today. Prof. Ulrike Protzer supported by the entire TherVacB team is on a mission to establish such a therapeutic hepatitis B vaccine for an HBV cure in routine clinical use.

To this end, the m4 Award and prize money of 500,000 Euros will play a vital role. It facilitates the essential development steps required for the ultimate formulation of the TherVacB vaccine after initial clinical trial results. Importantly, it supports preparations for the establishment of a spin-off company to drive further clinical development to finally make the TherVacB therapy broadly available to hepatitis B patients.

The Bavarian Ministry of Economic Affairs and Bio^M grant the m4 Award biennially to innovative academic research projects with spin-off potential in the field of biomedicine. The Munich Biotechnology Cluster Bio^M drives Bavarian Biotech Cluster Development by supporting biotech companies from the German Federal State of Bavaria at every stage of setting up their business. 

Experts in virology, immunology and clinical hepatitis from two research projects are working towards to cure hepatitis B: ‘IP-cure-B – Take care of your health’ and ‘TherVacB – A therapeutic vaccine to cure Hepatitis B’.

To jointly tackle some of the major challenges in the therapy of viral hepatitis, researchers have met for a first round of strategic discussions in July 2023.

The two research projects share the common goal to achieve functional cure of hepatitis B. For this, they investigate different aspects of the viral hepatitis B infection (HBV) and the HBV-mediated chronic disease:

IP-cure-B aims to improve the cure rate in patients with chronic hepatitis B (CHB) with complementary immunomodulatory concepts. Immune interventions are investigated in two settings, in a pre-clinical model and a proof-of-concept clinical study. Innovations in immunotherapy will boost the strategic selection of the best combination for effective treatment in future clinical studies.

TherVacB provides a novel curative treatment option that aims to break immune tolerance in chronic HBV infection. This will allow the immune system to clear the virus. New vaccine components will be tested in patients with CHB in a multicentre clinical proof-of-concept study. Finally, TherVacB aims to provide a new and affordable, safe and well tolerable treatment option to cure CHB – and a first opportunity for patients in Tanzania to be treated for hepatitis B.

The innovations from the two projects will be instrumental to meeting the United Nation’s Sustainable Development Goal 3:

• combat hepatitis B (and D) viral infection worldwide by the year 2030,
• ensure sustained health, increase the quality of life and stop stigmatization,
• including in highly endemic countries that cannot afford lifelong therapies and their monitoring.

Every year, more than a million lives are lost to hepatitis. The TherVacB team of clinical researchers, hepatologists and virologists is not waiting for change – we’re working hard to make it happen!

A better understanding of the hepatitis B infection and the HBV-mediated disease improves therapies – with your support as HBV patient!

As patient living with chronic hepatitis B in Italy, Spain, UK and Germany, you can join the European HBV Patient Registry anytime at one of TherVacB’s study centers. By joining, TherVacB clinicians will perform your routine visits. Additionally, the physicians will collect your patient data on virological and immunological parameters in a systematic way. Since its launch, the collection of patient data has been growing continuously. This collection helps clinicians to identify patients for the upcoming TherVacB vaccination trial and other studies on HBV treatment and cure. With your support, researchers can better understand the natural course of a hepatitis B infection, develop or refine therapies and help you and the HBV community worldwide.

Are you interested? Have a look at the map of participating clinical sites in Europe. Read on about the purpose of the European Patient Registry. And reach out to us, if you are interested in taking part!

Stay in touch with the Community – Join the Community Forum on 25 July to mark World Hepatitis Day 2023 !

On 25th July, 2 PM CEST / 1 PM BST, the World Hepatitis Alliance hosts the FREE and fully virtual WHD Community Forum. Join in for insights into the experiences, perspectives and unmet needs of people diagnosed with and living with hepatitis across the world. The panelists will explore global conversations around eliminating hepatitis by 2030 and why we are not waiting for hepatitis elimination. People living with hepatitis are welcome to share experiences and offer possible solutions to address challenges faced, as a result of the disease.

Do you want to join? Register anytime by clicking this link!

European Testing Week 2020 aims to increase testing efforts & promote awareness on the benefits of hepatitis/HIV testing!

More details here.