SK bioscience and GSK start phase III trial of adjuvanted COVID-19 vaccine candidate.
The randomised, active-controlled global trial will enrol around 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 III trials to compare two different COVID-19 vaccine candidates.
The advance to Phase III study follows positive interim Phase 1/II data which 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 this ongoing study.
Results from the Phase III study are expected 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.
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