COVID-19: Sanofi, GSK launch clinical trial for protein-based vaccine candidate

French pharmaceutical giant Sanofi and British drugmaker GSK have started a clinical trial for protein-based COVID-19 vaccine candidate amid global vaccine race. Sanofi and GSK said in a joint statement on September 3 that they kicked-off the “Phase ½” clinical trial for their adjuvanted COVID-19 vaccine. 

According to the pharma companies, the vaccine candidate uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology. The clinical trial is a randomized, double-blind and placebo-controlled trial designed to evaluate the safety, tolerability and immune response of the COVID-19 vaccine candidate. 

A total of 440 volunteers have been enrolled in the Phase ½ study across 11 investigational sites in the United States and the companies anticipate first results in early December. If the results are positive, the companies will initiate Phase 3 trial by the end of the year. They will then move for regulatory approval in the first half of 2021 if they get sufficient data for licensure application.

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Phase 3 trial by year-end

Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said in a statement that Sanofi and GSK bring proven science and technology to the fight against the global COVID-19 pandemic. Triomphe stated that the initiation of the clinical study is an important step and brings them closer to a potential vaccine which could help defeat COVID-19. 

“Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December. Positive data will enable a prompt start of the pivotal phase 3 trial by the end of this year,” he added.

The vaccine candidate has been developed in collaboration with the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services. Roger Connor, president of GSK Vaccines said in a statement that the clinical trial is an important moment in the progress towards addressing the pandemic.

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