With over 3% of the world’s population affected by chronic hepatitis B, TherVacB has the potential to address a critical unmet need for a cure.
The first in-human clinical trial of TherVacB, a novel therapeutic vaccine designed to cure chronic hepatitis B, has been initiated.1
Man holding photo of liver / Sewcream Studio - stock.adobe.com
The phase 1a, open label, escalating dose study (NCT05727267) has recruited 24 healthy patients aged 18 to 65 years in its cohort. While the current clinical trial aims to evaluate the safety and immunogenicity profiles of TherVacB, preparations have begun to initiate the next phase 1b/2a trial to further study its safety and efficacy profiles.
Developed by scientists at Helmholtz Munich alongside the German Center for Infection Research and the Proof-of-Concept Initiative of the Helmholtz Association and the Fraunhofer-Gesellschaft, TherVacB takes a therapeutic approach to treating chronic hepatitis B. Whereas prophylactic vaccines work to prevent illness, therapeutic vaccines stimulate the immune system to cure present illness.
Research for the novel TherVacB has suggested that successful treatment of chronic hepatitis B relies heavily on the proper activation of CD4 T-cells during the priming phase of vaccination. In a trial that compared the effectiveness of the vaccine in mouse models with and without T-cells, investigators found that the vaccine did not protect mice without T-cells, pointing to the cells’ central role in supporting TheraVacB’s therapeutic properties.2 Leveraging these insights, the TherVacB vaccine takes on a novel therapeutic approach to cure hepatitis B infection by activating CD4 T-cells, previously made ineffective via mechanism of the hepatitis B virus, in the immune system.
“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,” according to Ulrike Protzer, leading vaccine scientist.1 “Our approach is designed to induce exactly the type of immunity required and cover a broad spectrum of over 95% of hepatitis B virus strains worldwide.”
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Chronic hepatitis B is an inflammatory liver disease caused by the hepatitis B virus. For some, the infection can persist throughout a lifetime, causing liver damage, cirrhosis, liver cancer, and death.
The condition is a global health issue affecting more than 296 million people worldwide and rising.1 It is especially prevalent in places like the WHO Western Pacific Region and the WHO African Region where vertical transmission, considered the most dominant cause of chronic infection, from mother to infant during childbirth often occurs.1,3 Other methods of transmission occur through blood or sexual contact.
Although some manufacturers have tried to develop therapeutic hepatitis B vaccines in past years, none have demonstrated antiviral efficacy among patients. Further, while antiviral medications work towards reducing the viral load for patients, no current treatment options cure chronic hepatitis B. Despite the availability of antiviral medications, only 22% of eligible individuals out of the estimated 300 million people with chronic hepatitis B actually receive them.4
What’s more, chronic hepatitis B often requires indefinite treatment with medications that are not universally available.1,5
With over 3% of the world’s population affected by chronic hepatitis B, TherVacB has the potential to address a critical unmet need for a cure.2
The phase 1a clinical trial, sponsored by the University Medical Center Hamburg-Eppendorf, is underway at the Division of Infectious Diseases and Tropical Medicine at the LMU University Hospital Munich. Funded by the European Union, the full study is planned to take place in Germany, Italy, Spain, England, and Tanzania.
Results from the trial are anticipated to be released by the end of 2024.
READ MORE: Immunization Resource Center
