Sanofi and GSK initiate global Phase 3 clinical efficacy study of the COVID-19 vaccine candidate
The randomized, double-blind, placebo-controlled study will enroll over 35,000 adult volunteers (18 years +) across the US, Asia, Africa, and Latin America, to assess the safety, efficacy, and immunogenicity of an adjuvanted recombinant-protein COVID-19 vaccine candidate. This follows promising interim Phase 2 results showing that the vaccine candidate
achieved high rates of neutralizing antibody responses in adults, including that with evidence of prior SARS-CoV-2 infection.
The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults; secondary endpoints are the prevention of both severe COVID-19 disease as well as asymptomatic infection. The study’s two-stage design will evaluate vaccine formulations targeting the original D.614 virus (Wuhan), and subsequently the B.1. 351 (South African) variant and the diversity of geographies will allow for evaluation across various circulating variants.
Clinical studies to assess the ability of the vaccine candidate to generate a strong booster response regardless of the initial vaccine platform will also be initiated following the encouraging Phase 2 results. “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 a testament to the urgency and agility in our approach to
helping overcome the ongoing impact of this pandemic,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. “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” added Roger Conner, President of GSK Vaccines. The vaccine could be approved/authorized, pending positive outcomes from the study, in Q4 2021. The vaccine will be ready for rapid access if approved.
About the GSK/Sanofi Partnership
Sanofi’s recombinant technology combined with GSK’s adjuvant offers stability at temperatures used for routine vaccines, ensuring it is easy to both implement and distribute at a global scale via existing infrastructures. It also has the potential to generate high and sustained immune responses and to prevent virus transmission.