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.
"We are thrilled to start the clinical trials of a COVID-19 vaccine candidate in collaboration with SNU Hospitals and with support from KCDC/KNIH," said Dr. Jerome Kim, director general of IVI. "The trial is a crucial step in the development of an urgently needed COVID-19 vaccine. South Korea is one of the first countries in the world set to test a COVID-19 vaccine (after the US, China, UK, and Germany), and we are happy to collaborate with South Korean partners to accelerate clinical development of a COVID-19 vaccine through our partnership with INOVIO and CEPI."
Prof. Myung Don Oh of SNU Hospital, who will lead the clinical trial said, "Social distancing is making life challenging in all different aspects of our society including business, education, culture, sports, and international exchange, and we have reached a point where we cannot utilize social distancing further," adding "We have to return to normalcy and this launch of the vaccine clinical trial will provide significant momentum in easing fears over the pandemic and helping return to normalcy."
Dr. J. Joseph Kim, INOVIO's president & CEO, said, "As part of INOVIO's global coalition of COVID-19 vaccine collaborators, funders and manufacturers we look forward with enthusiasm to advance our DNA vaccine in partnership with the International Vaccine Institute (IVI) and Seoul National University Hospital to rapidly begin clinical trials in Korea, We will soon have phase 1 data from a US trial of INO-4800 and plan to begin phase 2/3 trials in mid-summer. We thank IVI and SNU Hospital for their work to speed the Korea trial of INO-4800."
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.
IVI and SNU Hospitals have collaborated in the past to conduct phase 1/2a trials for a MERS coronavirus vaccine. The MERS vaccine (INO-4700/GLS-5300) developed by INOVIO and South Korea's GeneOne Life Science and, in trials conducted so far, has achieved promising results