SK, GlaxoSmithKline Announce Phase 3 Study for COVID-19 Vaccine Candidate

SK Bioscience Co and GlaxoSmithKline (GSK) plc announced the start of a phase 3 clinical study for SK’s COVID-19 vaccine candidate, GBP510, in conjunction with GSK’s pandemic adjuvant, following positive results from the phase 1/2 trial.

“We are grateful that we were able to advance to the phase 3 study with the unprecedented support of global initiatives, including GSK, Coalition for Epidemic Preparedness Initiative, and the Bill & Melinda Gates Foundation,” Jaeyong Ahn, SK’s CEO, said in a statement. “Taking this important step towards overcoming the global pandemic situation, SK and GSK will bring our technical expertise together for the development of an adjuvanted protein-based vaccine candidate, GBP510.”

Phase 3 will consist of an active-controlled global randomized trial of about 4000 participants to evaluate the vaccine’s immunogenicity and safety while comparing it with the AstraZeneca/Oxford University COVID-19 vaccine, according to the statement.

This study will be the first global phase 3 to compare 2 different COVID-19 vaccine candidates.

“While many countries have made good progress with vaccinations, there remains a need for accessible and affordable COVID-19 vaccines to ensure equitable access and to protect people across the world,” Thomas Breuer, GSK’s chief global health officer, said in the statement. “We are pleased to contribute with GSK’s pandemic adjuvant and to be working with SK to deliver the vaccine at scale via COVAX if it is approved.”

Phase 1/2 showed that all participants who received the adjuvanted vaccine candidate developed a strong antibody response.

These neutralizing antibodies were between 5 and 8 times higher compared with individuals recovered from COVID-19, according to the statement.

There have been no identified safety concerns to date.

The vaccine, combined with GSK’s pandemic adjuvant, targets the binding domain spike protein of SARS-CoV-2 and was developed in collaboration with the Institute for Protein Design at the University of Washington as part of the Wave 2 vaccine investment project for more accessible and affordable COVID-19 vaccines, according to the statement.

Results are expected within the first half of 2022, and the vaccine is expected to be supplied worldwide through the COVAX facility, dependent on positive results and approval.

Reference

SK Bioscience and GSK start phase 3 trial of adjuvanted COVID-19 vaccine candidate. GlaxoSmithKline. News release. August 31, 2021. Accessed August 31, 2021. https://www.gsk.com/en-gb/media/press-releases/sk-bioscience-and-gsk-start-phase-3-trial-of-adjuvanted-covid-19-vaccine-candidate/