The adjuvanted recombinant COVID-19 vaccine produced by Sanofi and GSK has demonstrated strong immune responses across all adult age groups in its Phase II trial.
These positive results come after GSK and Sanofi’s original COVID-19 vaccine fell through due to a dosing error. Additionally, Medicago and GSK recently announced the start of Phase III clinical testing of Medicago’s plant-derived COVID-19 vaccine.
The trial, comprised of 722 volunteers, found that the vaccine achieved strong rates of neutralising antibody responses in line with those measured in people who have recovered from COVID-19.
The results demonstrated 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) with acceptable tolerability, and with no safety concerns.
Seroconversion is the development of specific antibodies in the blood as a result of infection or immunisation.
The antibody levels elicited by the vaccine 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 neutralising antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, which suggests the vaccine has strong potential for development as a booster shot.
A Phase III trial is expected to start in the coming weeks.
Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur said: “Our Phase II 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.
“With these favourable results, we are set to progress to a global Phase III 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.”
Roger Connor, President of GSK Vaccines said: “These positive data show the potential of this protein-based adjuvanted vaccine candidate in the broader context of the pandemic, including the need to address variants and to provide for booster doses.
“We believe that this vaccine candidate can make a significant contribution to the ongoing fight against COVID-19 and will move to Phase III as soon as possible to meet our goal of making it available before the end of the year.”
This is a syndicated feed from Pharmafile