SK Bioscience, GSK Initiate Phase 3 Trial Of COVID-19 Vaccine Candidate

(RTTNews) - SK bioscience and GlaxoSmithKline plc (GSK.L, GSK) said Tuesday that they have initiated a phase 3 clinical study of SK's COVID-19 vaccine candidate, GBP510, in combination with GSK's pandemic adjuvant following positive interim phase 1/2 results.

The trial will enroll about 4,000 participants from a range of countries and will aim to evaluate GBP510's safety and immunogenicity compared to an active comparator - the AstraZeneca/Oxford University COVID-19 vaccine.

The study will be one of the first global Phase 3 trials to compare two different COVID-19 vaccine candidates, GlaxoSmithKline said in a statement.

The interim Phase 1/2 data showed that all participants who received the adjuvanted vaccine candidate developed strong neutralizing antibody responses, demonstrating a 100% seroconversion rate. Neutralizing antibody titres were between five and a maximum of eight times higher compared to sera from people recovered from COVID-19. No safety concerns have been identified to date in the ongoing study.

The company expects results from the phase 3 study in the first half of 2022 after which, subject to positive results and regulatory approval, the vaccine is expected to be supplied at scale worldwide through the COVAX facility.