INOVIO, the International Vaccine Institute (IVI), and Seoul National University Hospital announced a partnership to start a Phase 1/2 clinical trial of INOVIO’s COVID-19 vaccine INO-4800 in South Korea.
The 2-stage trial of INO-4800, the first clinical study of COVID-19 vaccine in Korea, will assess the safety, tolerability, and immunogenicity of the candidate vaccine in 40 healthy adults aged 19-50 years, and will further expand to enroll an additional 120 people aged 19-64 years.
The trial, which aims to start later in June, is funded by the Coalition for Epidemic Preparedness Innovations (CEPI) through INOVIO and is supported by the Korea Center for Disease Control and Prevention/Korea National Institute of Health. In normal circumstances, it would generally take several years to start clinical trials of a new vaccine. In the midst of the COVID-19 pandemic, however, the trial in Korea will be conducted just two months after a similar clinical study began in the United States in early April 2020.
The speedy regulatory approval was made possible with support from the Korean Ministry of Food and Drug Safety following its adoption in April of a fast-track approval process for clinical trials of COVID-19 vaccines and therapeutics that are developed with a proven safety platform. Such vaccines, including DNA vaccines, can be exempt from toxicology tests leveraging the available preclinical data using the DNA platform, and expediting clinical trial review process. The DNA vaccine of US-based INOVIO to be tested was one of the first technologies to receive support from CEPI, greatly accelerating the development process of the COVID-19 vaccine.