GlaxoSmithKline (GSK) and Sanofi have begun enrolling participants into a Phase III clinical study of their adjuvanted recombinant-protein COVID-19 vaccine candidate.
The study, which will include more than 35,000 volunteers aged 18 years and older, will aim to evaluate if the vaccine can prevent symptomatic COVID-19 vaccine in participants who have not previously been infected with SARS-CoV-2.
It will also seek to determine if the jab can prevent severe COVID-19 disease and asymptomatic infections.
Using a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original D.614 virus – also known as the Wuhan strain – while the second stage will evaluate a formulation targeting the B.1.351 or South African variant.
“We have adapted our vaccine development strategy based on forward-looking considerations as the virus continues to evolve, as well as anticipating what may be needed in a post-pandemic setting. This trial is testament to the urgency and agility in our approach to help overcome the ongoing impact of this pandemic,” said Thomas Triomphe, executive vice president, global head of Sanofi Pasteur.
The vaccine candidate has been advanced into Phase III testing following positive results from a Phase II trial, which showed the vaccine candidate achieved high rates of neutralising antibody responses across all adult age groups.
“We believe further solutions for COVID-19 are very much needed to help reach people around the world, especially as the pandemic evolves and variants continue to emerge. Adjusting our technology and study designs reflects this need and will further build the potential of this adjuvanted protein-based vaccine,” said Roger Connor, president of GSK Vaccines.
GSK and Sanofi are eyeing a potential approval for the COVID-19 vaccine in the fourth quarter of 2021, depending on the outcomes from the Phase III trial as well as regulatory reviews.