Sanofi and GlaxoSmithKline began human testing Sept. 3 for their jointly developed COVID-19 vaccine candidate.
The two-dose candidate uses Sanofi's recombinant protein-based approach combined with a GlaxoSmithKline adjuvant that strengthens the body's immune response to the vaccine. Sanofi, the effort's lead partner, used the same approach for its licensed Flublok vaccine.
The trial is the first outside of China to utilize an approach for which there is already a licensed vaccine, according to STAT.
The drugmakers enrolled 440 healthy adults for the trial, which is taking place across 11 U.S. sites.
"The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat COVID-19," said Thomas Triomphe, Sanofi Pasteur's executive vice president and global head. "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."
The drugmakers hope to submit the vaccine for regulatory approval in the first half of 2021.