TherVacB: A therapeutic vaccine against hepatitis B

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The Munich DZIF team led by Prof. Ulrike Protzer is developing a novel therapeutic approach to cure chronic hepatitis B. Researchers at Helmholtz Zentrum München and Technical University of Munich (TUM) found that the large amount of hepatitis B virus proteins expressed in the liver prevents the body's immune system to defeat the virus, consequently preventing an effective therapy. The novel therapeutic vaccine – TherVacB – is now designed to suppress these viral proteins and boost the immune defence to enable a cure. The immunotherapeutic approach is expected to be tested in clinical trials in the first patients from January 2024.

„We are very pleased that for the clinical trials of TherVacB we are able to cooperate with a consortium of Europe’s leading virologists, immunologists and hepatologists, guided by Helmholtz Zentrum München.“
Ulrike Protzer
Prof. Dr. Ulrike Protzer
Coordinator of the DZIF research area „Hepatitis“

Background

Around 260 million humans, more than three percent of the world's population, are chronically infected by the hepatitis B virus. As a result, every year, 880,000 people worldwide die of liver failure or hepatocellular carcinoma. Currently no curative therapy is available. The therapies available to date inhibit virus replication, but need to be given long-term. As long as infected people cannot form an adequate immune response, the virus will survive. This is precisely where Prof. Ulrike Protzer, head of the Institute of Virology at Helmholtz Zentrum München and TUM and coordinator of the DZIF research area “Hepatitis”, and her team started.

Development

Chronic hepatitis B occurs because the viral proteins can suppress the body's immune response so that the disease persists. The research team has now developed a method to knock down the expression of these viral proteins. This enables certain of the patient's immune cells, known as CD8+ T-cells, to be reactivated in a second step via the newly developed vaccine called TherVacB. In mice, this vaccination was able to generate both neutralizing antibodies and T-cell responses – the hepatitis B infection was cured. Preclinical and toxicological studies in mice are currently being carried out. The vaccine is designed to target the majority of all hepatitis B viruses and therefore will be beneficial to most people infected worldwide.

Partners in Germany

The TherVacB Consortium – consisting of sixteen partners from five different European countries and one from Africa – will receive funding from the European Union within the program Horizon 2020.