The development of a therapeutic vaccine for Hepatitis B is a really very challenging over the past 20 years due to the virus's impact on specific immune cells. There are many research companies doing research on the cure of hepatitis b. But unfortunately, the proper solution unable to find as of now. After 12 years of basic research, TherVacB enters human trial phase-1a in January 25, 2024. The research team has plans to start a phase 1b, 2a trial in 2025 for chronic HBV patients, focusing on the vaccine's safety and efficacy across Germany, Italy, Spain, England, and Tanzania countries. “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,” said by Ulrike Protzer, Lead Scientist of the research team.
He also added, “our approach is designed to induce exactly the type of immunity required and cover a broad spectrum of over 95% of HBV strains worldwide.”
He also added, “our approach is designed to induce exactly the type of immunity required and cover a broad spectrum of over 95% of HBV strains worldwide.”
He also said, in this phase 1a, open-label, dose-escalation study aims is to test the safety and immunogenicity of TherVacB in 24 healthy volunteers aged between 18 to 65 years old.
There are two parts involves into phase1a clinical trial named were Part1, Part2.
Part I involves,11 participants, receiving protein prime vaccinations within 28 days, followed by an MVA-based boost on 56 days.
The participants are divided into three groups receiving and varying doses of
- HEPLISAV B,
- HBcoreAg for prime vaccinations, and
- Different doses of MVA-HBVac for the boost.
Part II involves,13 participants, who will undergo 2 protein prime vaccinations and an MVA-based boost but with varied doses of
- HBsAg,
- HBcoreAg, and
- Adjuvants across 3 groups.
TherVacB is a type of therapeutic vaccine. In contrast to prophylactic vaccines, these therapeutic vaccines are developed to treat an existing disease, like a chronic infection. These vaccines enhance the body's immune response to combat the disease.
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