[Asia Economy Reporter Chunhee Lee] Cha Vaccine Institute announced on the 3rd that it has completed the Phase 1 clinical trial administration of the 3rd generation hepatitis B preventive vaccine ‘CVI-HBV-002’.
Cha Vaccine Institute received approval for the domestic Phase 1 clinical trial plan (IND) of CVI-HBV-002 from the Ministry of Food and Drug Safety in June last year. Since then, screening was conducted on 30 adults aged 19 to 64 who tested negative for hepatitis B antibodies, and CVI-HBV-002 was administered. The institute will conduct follow-up observations for one year to evaluate safety, tolerability, and exploratory immunogenicity to prepare for the next phase of clinical trials.
Hepatitis B is considered one of the most common viral liver diseases. According to the World Health Organization (WHO), 2 billion people worldwide, approximately one in three, have been infected with the hepatitis B virus, and about 260 million people are chronic carriers of the virus. In particular, 72% of liver cancer patients are affected by the hepatitis B virus, indicating a strong correlation between hepatitis B and liver diseases.
CVI-HBV-002 contains the 3rd generation antigen L-HBsAg and the immune adjuvant 'L-pampo'. L-HBsAg is a 3rd generation antigen independently developed by Cha Vaccine Institute, which has higher immunogenicity than the 2nd generation antigen. Similarly, L-pampo, an immune adjuvant also independently developed by Cha Vaccine Institute, induces both humoral and cellular immune responses simultaneously, making it more effective than other immune adjuvants that mainly induce humoral immunity.
Based on these strengths, Cha Vaccine Institute expects that CVI-HBV-002 can induce protective effects even in non-responders who do not form antibodies and thus have no protective effect despite receiving existing hepatitis B vaccines. Currently, the commercially available 2nd generation preventive vaccines have confirmed over 80% preventive efficacy and safety, but about 5-10% of recipients are reported as non-responders. Non-responders remain at lifelong risk of hepatitis B as they do not generate antibodies even after vaccination.
Jungseon Yeom, CEO of Cha Vaccine Institute, said, “Developing a premium hepatitis B vaccine expected to be effective for non-responders can greatly contribute to public health promotion. We will do our best to promptly complete follow-up clinical trials including this Phase 1 and commercialize the vaccine by transferring technology to overseas markets such as China and Eastern Europe.”
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