Thervacb is a hepatitis B vaccine for chronic hepatitis B** designed and developed by scientists from Helmholtz Hospital in Munich, Germany, and jointly developed with the German Center for Infection Research, the Helmholtz National Research Center Federation, and the Fraunhofer Society. Designed to activate hepatitis B virus-specific B-cell and T-cell responses.
A few days ago, it was officially announced that the phase 1a clinical trial of the ** hepatitis B vaccine Thervacb has been officially launched, and the clinical trial is being conducted in the Department of Infectious Diseases and Tropical Medicine at the LMU University Hospital in Munich, with the Hamburg-Eppendorf University Medical Center as the sponsor of the clinical trial.
The study is an open-label, dose-escalation study to evaluate the safety and immunogenicity of thervacb in healthy volunteers aged 18 to 65 years, with results expected to be available and published by the end of 2024.
The World Health Organization (WHO) estimates that there are about 29.6 billion people suffer from chronic HBV infection and 820,000 people die each year. Current regimens include antiviral drugs that help reduce viral load and liver inflammation, but do not provide a regimen. In addition, nucleos(t)ide analogues, which constitute the current ** standard, must be taken daily and are not widely available worldwide. Therefore, the need for new methods is urgent.
According to the official, before the ** hepatitis B vaccine thervacb officially entered human clinical trials, the research team had conducted basic research on this for 12 years, after extensive preclinical testing, and in accordance with"Good Manufacturing Practices"Following the guidelines for the production of the vaccine, on January 25, 2024, the first human clinical trial of Thervacb was initiated, which was a significant milestone. The research is planned to be conducted in Germany, Italy, Spain, the United Kingdom, and Tanzania and is funded by the European Union as part of the Horizon 2020 research project.
Thervacb is a sexual vaccine. Unlike prophylactic vaccines to prevent disease, sexual vaccines are designed to prevent existing diseases, such as slow infection. Sex vaccines boost the body's immune system to fight disease. Over the past two decades, there have been several attempts to develop an effective ** hepatitis B vaccine, but so far there has been no success.
Ulrike Protzer, chief scientist of Thervacb vaccine development, said that the Thervacb vaccine is based on a deep understanding of the challenges faced by the immune system in chronic HBV infection, which requires simultaneous activation of B cells and CD4 and CD8 T cell responses to achieve immune control of HBV, and is the result of years of painstaking research in Munich. Our method is designed to precisely induce the desired type of immunity and cover more than 95% of the world's HBV strains.
According to official information, preparations are also underway for the Phase 1B 2A phase clinical trial aimed at evaluating the safety and efficacy of the Thervacb vaccine in patients with chronic hepatitis B, and it is planned to start in 2024.
**: Liver time