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Following 12 years of research, the first-in-human clinical trial of TherVacB, a therapeutic vaccine for the treatment of hepatitis B, was initiated on January 25, 2024, according to a press release.1
The trial is a Phase Ia, open-label, escalating dose study to evaluate the safety and immunogenicity of TherVacB in 24 healthy participants aged 18 to 65 years. Under the sponsorship of the University Medical Center Hamburg-Eppendorf, the Division of Infectious Diseases and Tropical Medicine at the LMU University Hospital Munich is responsible for conducting the clinical trial.
According to the World Health Organization, hepatitis B affects approximately 296 million people globally, including over 6 million children under the age of 5.2
“TherVacB is based on a deep understanding of the challenges of the immune system in chronic hepatitis B infection and is the result of years of dedicated research here in Munich,” said Ulrike Protzer, the leading scientist behind the vaccine in the press release. “Our approach is designed to induce exactly the type of immunity required and cover a broad spectrum of over 95% of hepatitis B strains worldwide.”
While the Phase Ia study is underway, preparations have begun for applying for the first-in-patient Phase Ib/IIa trial, aiming to assess the safety and efficacy of TherVacB in patients with chronic hepatitis B. This study is planned to take place in Germany, Italy, Spain, England, and Tanzania and is funded by the European Union as part of a Horizon 2020 research project.
According to the press release, researchers have found that the hepatitis B virus prevents certain immune cells of the body from becoming effective. Over the past two decades, attempts at developing an effective therapy for hepatitis B have been unsuccessful. In response, scientists at Helmholtz Munich, in collaboration with the German Center for Infection Research and the Proof-of-Concept Initiative of the Helmholtz Association and the Fraunhofer-Gesellschaft, have developed a novel therapeutic approach to activate these immune cells by therapeutic vaccination to cure chronic hepatitis B infection with TherVacB.
Results from the Phase Ia study (NCT05727267) of TherVacB are expected to be made public by the end of 2024.
References
- Therapeutic vaccine for chronic hepatitis B enters clinical trial. News release. February 22, 2024. Accessed February 23, 2024. https://www.eurekalert.org/news-releases/1035328
- Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021. World Health Organization. July 15, 2021. Accessed February 23, 2024. https://www.who.int/publications/i/item/9789240027077