SK Bioscience's GBP510 approved for Phase 3 trials in Vietnam
SK Bioscience is set to speed up global Phase 3 clinical trials of its GBP510 Covid-19 vaccine candidate.
It recently won an approval to start Phase 3 clinical trials of the vaccine candidate in Vietnam, according to International Vaccine Institute (IVI), which will be running clinical trials for the company outside of Korea. SK Bioscience is conducting trials in Korea.
The global clinical trials are likely to take place in five foreign countries — New Zealand, Vietnam, Ukraine, Philippines and Thailand.
“We recently received the nod to start Phase 3 clinical trials in Vietnam,” an IVI spokesperson told the Korea JoongAng daily. “We are currently waiting for approvals from the other four countries, while Ukraine would be most likely to give permission shortly.”
SK Bioscience already obtained permission from Korea's Ministry of Food and Drug Safety in mid-August and has begun administering the candidate to participants. It is the first domestic Covid-19 vaccine candidate to get the nod to start Phase 3 clinical trials, the last round required for a vaccine.
GBP510's Phase 3 clinical trials will be conducted on a total of 3,990 people aged 18 and older using comparative-style clinical trials, which compare the immunogenicity of an already-authorized vaccine with a candidate under development in order to prove its efficacy. In total, 3,000 people will be injected with SK Bioscience’s GBP510, while 990 will get AstraZeneca vaccines. They will receive two doses of 0.5 milliliters (0.017 ounces) at four-week intervals.
SK Bioscience aims to test the candidate’s immunogenicity and safety through the Phase 3 clinical trials and release the interim results by the first half of next year.
Selected as the first vaccine candidate for Coalition for Epidemic Preparedness Innovation (CEPI)’s “Wave 2” initiative, SK Bioscience received a total of $213.7 million from CEPI and the Bill & Melinda Gates Foundation for the development of GBP510.
BY SARAH CHEA [email@example.com]