First Human Trial for Hepatitis B Vaccine Initiated

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TherVacB trial for hepatitis B marks a milestone in combating chronic HBV infection. 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.

‘The initiation of the first-in-human clinical trial of TherVacB marks a significant advancement in combatting chronic hepatitis B caused by HBV infection, following rigorous preclinical testing and adherence to Good Manufacturing Practice guidelines. #hepatitisb #thervacb #clinicaltrial ’

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.

TherVacB's Landmark Clinical Trial Begins

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.

TherVacB 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.

Pioneering Treatment for Chronic Hepatitis B

TherVacB is 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."

Reference:

1. A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate - (https:clinicaltrials.gov/study/NCT05727267?term=ThervacB&rank=1)

Source: Eurekalert