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News|Articles|September 1, 2021
SK Bioscience and GSK Start Phase III Trial of Adjuvanted COVID-19 Vaccine Candidate
Author(s)Pharmaceutical Technology Editors
SK and GSK announce the initiation of a Phase III clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant.
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SK bioscience (SK) and GlaxoSmithKline (GSK) announced the initiation of a Phase III clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant following positive interim Phase I/II results in an Aug. 31, 2021 press release. The Phase III clinical study is a randomized, active-controlled global trial that will enroll approximately 4,000 participants. It will evaluate GBP510’s safety and immunogenicity compared to the AstraZeneca/Oxford University COVID-19 vaccine. This will be one of the first global Phase III trials to compare two different COVID-19 vaccine candidates.
Interim Phase I/II data showed that participants who received the adjuvanted vaccine candidate developed strong neutralizing antibody responses, demonstrating a 100% seroconversion rate. No safety concerns have been identified to date in the ongoing study.
Results from the Phase III study are expected in the first half of 2022. The vaccine is then expected to be supplied worldwide through the COVAX facility, pending positive results and regulatory approval.
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