New Hepatitis B Vaccine Shows Promising Results in Clinical Trials: Could Revolutionize Preventive Vaccination Efforts

There are two types of hepatitis. Acute disease is caused by hepatitis A virus, which is transmitted through contaminated water or food, and can also be caused by hepatitis B virus or hepatitis C virus. Blood-borne hepatitis is a chronic disease that often progresses to cirrhosis and liver cancer. /Select DB

The third-generation hepatitis B vaccine candidate developed by the CHA Vaccine Research Institute (261780), an affiliate of CHA Biotech, was found to show a high immune response even after a single vaccination. Accordingly, the DRC Vaccine Research Institute plans to develop this candidate material into Korea’s first two-dose hepatitis B preventive vaccine.

The CHA Vaccine Research Institute announced on the 28th that it had received a clinical trial results report with this content the day before. The CHA Vaccine Research Institute received approval for a domestic phase 1 clinical trial (IND) plan from the Food and Drug Safety Administration in June 2021, and completed administration to 30 adult men and women in November 2022.

Safety, responsiveness and immunogenicity were evaluated for approximately 4 months (48 weeks). As a result, when evaluating the seroprotection rate, which is the primary indicator, the protection rate was 92.86%, or 28 out of 29 patients, after the first administration. This means that with just one vaccination, enough serum is created to protect against the hepatitis B virus. According to the company, sufficient immunity was confirmed in all 29 patients after 48 weeks of follow-up after the third dose.

Hepatitis B is a disease caused by infection with a virus. According to the World Health Organization (WHO), 2 billion people worldwide are infected with the hepatitis B virus, and approximately 260 million of them carry the virus in their bodies. Such chronic hepatitis B patients develop liver cancer without cirrhosis, and the risk of developing liver cancer is four times higher than the general population.

For this reason, the US Centers for Disease Control and Prevention (CDC) published a policy recommending that adults aged 19 to 59 be vaccinated against hepatitis B in April 2022, and the hepatitis B vaccine market is growing. The problem is that the vaccination process for the current hepatitis B vaccine is cumbersome.

The hepatitis B vaccines approved in Korea are second generation vaccines such as GlaxoSmithKline (GSK)’s Engerix-B, MSD’s Recombivax, and LG Chem’s ‘Uvaxvi’. You must be vaccinated twice. In the United States and Europe, a third-generation vaccine requiring only two doses per month has been developed and approved for use, but has not yet been introduced in Korea.

Accordingly, the DRC Vaccine Research Institute plans to develop Korea’s first two-dose hepatitis B preventive vaccine. The company believes that reducing the number of vaccine doses can improve access to vaccinations and contribute to national health.

“Based on the successful results of phase 1 clinical trials, we plan to pursue global phase 2 clinical trials targeting 2 to 4 countries, including Korea,” said Yeom Jeong-seon, CEO of the Vaccine Research Institute CHA. “We will finalize the clinical. trial countries after a feasibility study and start the trial in 3 months in 2024.” “We will submit the IND during the quarter,” he said.

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