GSK, Sanofi COVID vaccine Phase 2 trial shows strong immune responses across all adult age groups
Paris: The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers.
A global pivotal Phase 3 study is expected to start in the coming weeks.
The Phase 2 interim results showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses, with acceptable tolerability and with no safety concerns. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old). After a single injection, high neutralizing antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
"Our Phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and booster vaccines, which can be stored at normal temperatures, increases", said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. "With these favorable results, we are set to progress to a global Phase 3 efficacy study. We look forward to generating additional data and working with our partners around the world to make our vaccine available as quickly as possible."
The randomized, double-blind, multi-center-dose-ranging study was conducted in healthy adults aged 18 years of age and older, including those with high risk medical conditions, to evaluate the safety, reactogenicity, and immunogenicity of two injections given 21 days apart, with 3 antigen dose levels of 5, 10 and 15 µg. Beginning in February 2021, the study enrolled 722 volunteers in the U.S. and Honduras. It included equivalent numbers of adults 18 to 59 years and those 60 years and above.
Read also: Sanofi enters three-year collaboration with Stanford Medicine to advance immunology research
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