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 Munich 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. A Phase Ia clinical trial was initiated in January 2024. The first volunteers are now receiving the TherVacB vaccine.

„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 Munich.“
Ulrike Protzer
Prof. Dr. Ulrike Protzer
Coordinator of the DZIF research area "Hepatitis"

Background

According to the WHO, around 254 million people are chronically infected by the hepatitis B virus. As a result, an estimated 1.1 million people worldwide die of liver failure or hepatocellular carcinoma every year. Currently, there is no cure. Available therapies inhibit virus replication but require long-term administration. As long as infected individuals cannot mount an adequate immune response, the virus will persist. This is precisely where Prof. Ulrike Protzer and her team started. Prof. Protzer is the head of the Institute of Virology at Helmholtz Munich and TUM, as well as the coordinator of the DZIF research area Hepatitis.

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. 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 17 partners from five different European countries and one from Africa—will receive funding from the European Union within the program Horizon 2020.