2024-02-01 09:04:07
Photo/Cha Vaccine Research Institute
CHA Vaccine Research Institute announced on the 1st that it has secured the topline results of phase 1 clinical data for the third-generation hepatitis B preventive vaccine ‘CVI-HBV-002’.
This is the top line (main indicator) result of the Clinical Trial Results Report (CSR).
CHA Vaccine Research Institute received IND approval for the domestic phase 1 clinical trial of the third-generation hepatitis B preventive vaccine from the Ministry of Food and Drug Safety in June 2021.
Afterwards, in November 2022, CVI-HBV-002 administration was completed to 30 adults between the ages of 19 and 65. ▲Safety ▲Reactivity ▲Immunogenicity, etc. were evaluated through 48 weeks of follow-up observation.
CVI-HBV-002 contains the third-generation recombinant protein antigen L-HBsAg and the immune enhancer L-pampo, independently developed by CHA Vaccine Research Institute.
L-HBsAg is a third-generation antigen and has a preventive effect 200 times higher than the currently used second-generation antigen. L-pampo simultaneously induces humoral and cellular immune responses.
Clinical results showed that the test subjects’ seroprotection rate (SPR) was ▲92.86% after the first administration, ▲100% after the second administration, ▲100% after the third administration, and ▲100% at the last visit after 48 weeks of long-term follow-up. This means that all test subjects achieved seroprotection.
This is an excellent result compared to the existing vaccine, which showed a seroprotection rate of 81.3% after three doses.
It was also confirmed that antibodies were formed quickly, showing a 100% seroprotection rate with just two doses. There were no serious adverse reactions in the adverse reaction evaluation.
In this clinical trial, subjects who received the existing hepatitis B vaccine but did not develop antibodies or had no history of hepatitis B vaccination and whose antibodies to hepatitis B were negative during screening also participated.
CHA Vaccine Research Institute plans to develop CVI-HBV-002 as Korea’s first two-dose hepatitis B preventive vaccine. Reducing the number of vaccine doses can increase access to vaccinations, ultimately contributing to improving national health.
Jeong-seon Yeom, CEO of CHA Vaccine Research Institute, said, “We will do our best for commercialization, including starting a global phase 2 clinical trial within this year and transferring technology to China and Eastern Europe.”
Meanwhile, hepatitis B is the most common viral liver disease. According to the World Health Organization (WHO), 2 billion people, or one in three people around the world, are infected with the hepatitis B virus. Approximately 260 million people chronically carry the hepatitis B virus.
The hepatitis B vaccine market for adults is gradually growing, with the U.S. CDC (Centers for Disease Control and Prevention) announcing a policy recommending that all adults between the ages of 19 and 59 be vaccinated against hepatitis B in 2022. .
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