Sanofi-GSK Phase III trial begins for COVID-19 vaccine
pharmafile | May 27, 2021 | News story | |
Sanofi and GSK have begun their Phase III clinical study to assess the safety, efficacy, and immunogenicity of their COVID-19 vaccine today.
The global, randomised, double-blind placebo-controlled Phase III study will include more than 35,000 volunteers aged 18 and older from several countries, inluding sites in the US, Asia, Africa, and Latin America.
The design of the Phase III trial, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the vaccine against a variety of circulating variants.
The Phase III study follows the interim Phase II results which showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralising antibody responses in all adult age groups, with 95 to 100% seroconversion rates.
After a single injection, high neutralising antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
Thomas Triomphe, Executive Vice President, Global Head of Sanofi Pasteur, said: “We are encouraged to see first vaccinations starting to take place in such an important, pivotal Phase III study, as we believe that our unique technology platform will provide a clinically-relevant vaccine option.
“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 help overcome the ongoing impact of this pandemic.”
Roger Connor, President of GSK Vaccines, said, “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. 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.”
Lilly Subbotin
