Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.
The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.
Prevention of symptomatic COVID-19 in SARS-CoV-2 naive adults constitutes the primary endpoint, while the prevention of severe COVID-19 disease and prevention of asymptomatic infection makes up the secondary endpoints.
Stage one of the study will investigate the efficacy of the vaccine formulation targeting the original D.614 virus (Wuhan) while a second stage will evaluate a second formulation targeting the South African (B.1.351) variant. The global study offers a chance to evaluate the vaccine candidate against a number of circulating variants across the world, the companies said.
Additionally, after observing encouraging interim Phase 2 results, the companies plan to begin clinical studies to assess the vaccine candidate’s ability to generate a strong booster response regardless of the initial platform received.
GlaxoSmithKline and Sanofi in December confirmed a delay in their adjuvanted recombinant protein-based COVID-19 vaccine owing to an inadequate immune response in older adults in a Phase 1/2 trial. Sanofi has since agreed with Pfizer and BioNTech to support the manufacturing of their vaccine.
“We are encouraged to see first vaccinations starting to take place in such an important, pivotal Phase 3 study, as we believe that our unique technology platform will provide a clinically relevant vaccine option,” EVP & global head of Sanofi Pasteur Thomas Triomphe said in the release. “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.”
“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,” added GSK vaccines president Roger Connor. “Adjusting our technology and study designs reflects this need and will further build the potential of this adjuvanted protein-based vaccine. We are grateful to the volunteers who will take part in the trials and hope the results will add to the encouraging data we’ve seen so far so we can make the vaccine available as quickly as possible.”