CHA Vaccine Research Institute (CEO Yeom Jeong-seon), an affiliate of CHA Biotech, announced the Phase 1 Clinical Trial Result Report (CSR) results (key indicators) of China’s preventive hepatitis B vaccine on the 30th. third generation ‘CVI -HBV-002’. .
The CHA Vaccine Research Institute received IND approval for national phase 1 clinical trials of the third-generation preventive hepatitis B vaccine from the Ministry of Food and Drug Safety in June 2021. In November 2022, the administration of CVI-HBV-002 was completed in 30 adults aged 19 to 65 years. Subsequently, a follow-up was conducted for 48 weeks to evaluate safety, reactivity and immunogenicity.
To evaluate the immunogenicity of CVI-HBV-002, we examined the rate of seroprotection. As a result, the seroprotection rate (SPR,%) of the tested subjects was 92.86% after the first dose, 100% after the second dose, 100% after the third dose and 100% at the last visit after 48 weeks of prolonged treatment. Term follow-up seroprotection rate achieved. This is an excellent result compared to the previously approved vaccine, which showed a seroprotection rate of 81.3% after three doses.
According to the company, CVI-HBV-002 showed a 100% seroprotection rate with just two doses, confirming that antibodies formed quickly. In the evaluation of adverse reactions, safety was confirmed as no serious adverse reactions occurred in all subjects.
Furthermore, in this clinical trial, among those who received the existing hepatitis B vaccine but did not develop antibodies (non-responders) or who had no history of hepatitis B vaccination, those who tested negative for hepatitis B antibodies at the time of screening (screening test) All participants achieved and maintained a seroprotection rate of 100%.
The CHA Vaccine Research Institute plans to develop CVI-HBV-002 as the first two-dose preventive Korean hepatitis B vaccine. Reducing the number of vaccine doses can increase access to vaccinations, ultimately helping to improve the nation’s health. It is expected to be a vaccine for those who have not been effective with existing vaccines.
Jeong-seon Yeom, CEO of the CHA Vaccine Research Institute, said: “This clinical trial demonstrated not only safety but also high immune efficacy, confirming the possibility of overcoming the limitations of existing vaccines.” clinical trials later this year and develop the technology in China and Eastern Europe.” “We will do our best to market it, including the transfer,” he said.
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 and approximately 260 million people are chronically affected by the hepatitis B virus.
The US Centers for Disease Control and Prevention (CDC) announced a policy recommending that all adults aged 19 to 59 be vaccinated against hepatitis B in April 2022, and the hepatitis B vaccine market hepatitis B for adults is on the rise.
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