The CHA Vaccine Research Institute, an affiliate of CHA Biotech, announced on the 3rd that it has successfully completed phase 1 clinical administration of the third generation hepatitis B vaccine ‘CVI-HBV-002’.
In June last year, the Tea Vaccine Research Institute received approval for a domestic phase 1 clinical trial (IND) of a third-generation hepatitis B vaccine from the Food and Drug Safety Administration. CVI-HBV-002 was given to 30 adults between the ages of 19 and under 65 who tested negative for hepatitis B antibodies during screening. It will prepare for the next phase of clinical trials by evaluating safety, tolerability, and exploratory immunogenicity during a one-year follow-up.
This vaccine contains the third generation antigen (L-HBsAg) and the adjuvant L-pampo™. L-HBsAg is a third generation antigen developed by the Tea Vaccine Research Institute, and its immunogenicity is significantly higher than the second generation antigen. Based on these strengths, it is expected that it will be possible to induce a protective effect even in the non-responder group, which has no protective effect even if they receive the current hepatitis B vaccine.
“If we develop a premium hepatitis B vaccine, which is expected to have a preventive effect on non-responders who make up 5-10% of the total population, it can greatly contribute to national health,” said Yeom Jeong -seon, CEO. from the Tea Vaccine Research Center We will do our best to commercialize it by transferring technology to foreign markets such as China and Eastern Europe,” he said.
Meanwhile, hepatitis B is the most common viral liver disease. According to the World Health Organization (WHO), 2 billion people, or 1 in 3 people worldwide, are infected with the hepatitis B virus. Around 260 million people are chronically infected with hepatitis B virus. There is a high correlation between hepatitis B and liver disease, as hepatitis B virus affects 72% of liver cancer patients.