Therapeutic Vaccine for Chronic Hepatitis B Enters Clinical Trial
TherVacB, a novel therapeutic vaccine to combat chronic hepatitis B, entered the first clinical trial. The vaccine was designed and developed under the leadership of Helmholtz Munich. This phase 1a clinical trial is conducted at the Division of Infectious Diseases and Tropical Medicine at the LMU University Hospital Munich with the University Medical Center Hamburg-Eppendorf as sponsor of the clinical trial and will investigate the safety and immunogenicity of the novel vaccine candidate in healthy volunteers. The first clinical trial in patients with chronic hepatitis B is being prepared and scheduled to start in 2024.
Global Challenge: Chronic Hepatitis B Threatens Millions With No Current Cure
Chronic hepatitis B, resulting from infection with the hepatitis B virus (HBV), is an inflammatory liver disease that results in tissue damage. Persistent HBV infection, where the immune system cannot fully eradicate the virus, can lead to continuous liver damage, liver cirrhosis, and even liver cancer. HBV infection has a high global prevalence, particularly in areas where vertical transmission during childbirth is dominant. Transmission occurs through blood, sexual contact, or from mothers to their newborns. The latter is the most frequent cause of chronic infection. The World Health Organization (WHO) estimates that around 296 million people worldwide are living with chronic HBV infections; 820,000 humans die each year from the consequences. Current treatment options involve antiviral medications that help reduce the virus load and liver inflammation but do not provide a curative solution. Furthermore, nucleotide analogs that form the current standard of care must be taken daily and are not universally available worldwide. Consequently, there is an urgent need for curative treatment.
After 12 years of basic research: TherVacB Enters Human Trial
After extensive preclinical testing and the production of the vaccine adhering to the guidelines of ‘Good Manufacturing Practice’, a pivotal milestone was achieved on January 25, 2024, when the first-in-human clinical trial of TherVacB was initiated. This is a phase 1a, 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 with coordinating investigator Prof. Dr. Marylyn Addo, the Division of Infectious Diseases and Tropical Medicine at the LMU University Hospital Munich (Principal Investigator Dr. Mirjam Schunk) is responsible for conducting the clinical trial. Simultaneously, preparations are underway for applying for the first-in-patient phase 1b/2a trial, aiming to assess the safety and efficacy 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.
TherVacB: Innovative Vaccine Design for Potential Cure
TherVacBis a therapeutic vaccine. Unlike prophylactic vaccines that prevent illnesses, therapeutic vaccines aim to cure an existing disease, such as a chronic infection. Therapeutic vaccines boost the body’s immune system to fight against the disease. Over the past two decades, numerous attempts have been made to develop effective therapeutic hepatitis B vaccines, but none have been successful so far. Researchers found that the hepatitis B virus prevents certain immune cells of the body from becoming effective. Building upon these discoveries, 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 HBV infection.
“TherVacB is based on a deep understanding of the challenges of the immune system in chronic HBV infection and is the result of years of dedicated research here in Munich,” says Ulrike Protzer, the leading scientist behind the vaccine. “Our approach is designed to induce exactly the type of immunity required and cover a broad spectrum of over 95% of HBV strains worldwide.”
Further information
Phase 1a clinical trial results are expected to be public by the end of 2024. Read more about the details of the clinical trial. For those who are interested in participating in the TherVacB trial, you can find out more at www.impfstudien-tropeninstitut.de.
About the scientists
Prof. Dr. Ulrike Protzer, Deputy Head of the Molecular Targets and Therapies Center at Helmholtz Munich, Director of the Institute of Virology at Helmholtz Munich and the Technical University of Munich, Professor of Virology at TUM School of Medicine and Health
Prof. Dr. Marylyn Addo, Director of the Institute for Infection Research and Vaccine Development, University Medical Center Hamburg-Eppendorf and Bernhard-Nocht-Institute for Tropical Medicine
Dr. Mirjam Schunk, Head of the Clinical Study Center at the Division of Infectious Diseases and Tropical Medicine, LMU University Hospital Munich
