Published : Nov. 5, 2021 - 15:12
SK Bioscience’s vaccine manufacturing plant in Andong, North Gyeongsang Province (SK Bioscience)
SK Bioscience announced Friday positive results from phase 1 and 2 clinical studies of its COVID-19 vaccine candidate GBP510, increasing the prospect of Korea’s first homegrown coronavirus vaccine debuting next year.
The Korean firm said people who received the vaccine candidate had neutralizing antibodies at levels 3-6 times higher than those of people who recovered from COVID-19.
No severe side effects were reported during the clinical studies, it added.
The phase 1 and 2 clinical trials involved 328 healthy adults from 14 medical institutions in South Korea. The company administered GBP510, together with GlaxoSmithKline’s adjuvant.
SK Bioscience will report the clinical results to the local health authority.
The company plans to conduct the last, third-stage trial of the vaccine candidate, in Korea and five other countries -- Vietnam, New Zealand, Ukraine, the Philippines, and Thailand. The clinical trial will involve a total of 3,990 people aged 18 and older and will compare GBP510 against the COVID-19 vaccine by AstraZeneca.
Last month, Vietnamese authorities gave a nod to the phase 3 trial. The company is waiting for final approvals in other countries. The company expects to begin phase 3 clinical studies in other four countries as early as next month. The International Vaccine Institute is responsible for clinical trials of GBP510 overseas.
In South Korea, the Ministry of Food and Drug Safety granted its approval in August and the firm has begun administering the vaccine candidate to participants in the same month.
The vaccine candidate is a recombinant-protein vaccine based on novel two-component nanoparticles that can maximize the immune effect.
(ws@heraldcorp.com)