- Recruitment of global Phase III clinical trial of ‘GBP510’ completed, with vaccine expected to be authorized in the first half of 2022
- A booster dose study is concurrently being planned to bring additional vaccine to the global COVID-19 vaccine market
January 19, 2022 SEOUL, Korea — The International Vaccine Institute (IVI) and SK bioscience announced on January 18 that they have completed the recruitment of participants for the Phase III global clinical trial of GBP510, SKBS’ COVID-19 vaccine candidate. The Phase III clinical trial is the final stage of development to verify the safety and immunogenicity of the vaccine.
The 4,037 participants in the Phase III clinical trial of GBP510 are adults aged 18 and older, including 570 people in Korea and 3,467 in five other countries in Europe, Southeast Asia, and Oceania. This trial was conducted across 38 clinical trial sites (including 16 in Korea). IVI and SK bioscience are jointly conducting the global clinical study dubbed the ‘COVID vaccine Clinical and Operational Alliance (COCOA).’
As the next step, the Korea National Institute of Health and IVI are also sequentially receiving and analyzing samples from all the participating countries with the aim to speed up regulatory submissions as soon as immunogenicity data is made available. The COCOA consortium is also conducting additional clinical trials of GBP510 as a booster vaccine to respond to additional variants of concern. There will be two parallel booster dose clinical trials, one in Korea for the phase I/ II trial participants and one for the COCOA study. The booster dose will be provided after 6 months of receiving the primary series to understand its effect on immune responses. Additional studies of the vaccine are being planned, including a clinical trial in children and adolescents.
Based on the results of the Phase III and booster clinical trials, SK bioscience will submit applications for WHO certification and emergency use authorization of GBP510 in each participating country. GBP510 was the first COVID-19 vaccine candidate to be selected as a part of Wave 2, a project initiated by the Coalition for Epidemic Preparedness Innovations (CEPI) in 2020 to support promising vaccine candidates. Once licensed, hundreds of millions of GBP510 doses will be made available to the COVAX Facility for procurement and equitable allocation worldwide. GBP510 is expected to become an additional tool in the ongoing fight against the COVID-19 pandemic.
GBP510 is a recombinant protein-based COVID-19 vaccine candidate developed jointly with the Institute for Protein Design (IPD) at the University of Washington, adjuvanted with GlaxoSmithKline’s (GSK) adjuvant (AS03). The recombinant protein platform adopted for GBP510 has been also used for the development of current influenza (flu), hepatitis B, and cervical cancer vaccines. The vaccine is expected to contribute to increasing the global vaccination coverage including in low-income countries through a relatively easier distribution method, as it can be stored in normal cold-chain conditions of 2 to 8 degrees Celsius, and could create a market differentiated by inducing inoculation to people who are reluctant to take currently authorized COVID-19 vaccines.
Dr. Sushant Sahastrabuddhe, Associate Director General at IVI and Director of the COCOA program said, “This is a major milestone that we have achieved with our partners in 6 countries and would like to thank all the participants, investigators, site staff, partner CROs and the amazing teams at IVI and SK bioscience. This was a challenging study with many restrictions because of COVID-19 related lockdowns. However, with the support from our partners in these countries (Korea, New Zealand, The Philippines, Thailand, Vietnam and Ukraine), we managed to complete recruitment in time. We look forward to collaborating with SK bioscience, KNIH and all partners in the countries involved to successfully complete the trial and bring a new COVID-19 vaccine to the global health market.”
About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a nonprofit inter-governmental organization established in 1997 at the initiative of the United Nations Development Programme (UNDP). IVI has 36 countries and the World Health Organization (WHO) on its treaty, including the Republic of Korea, Sweden, India, and Finland as state funders.
Our mandate is to make vaccines available and accessible for the world’s most vulnerable people. We focus on infectious diseases of global health importance such as cholera, typhoid, shigella, salmonella, schistosomiasis, chikungunya, group A strep, Hepatitis A, HPV, TB, HIV, MERS, COVID-19, as well as antimicrobial resistance. For more information, please visit https://www.ivi.int
Phone: +82 2 881 1439