Sanofi and GlaxoSmithKline (GSK) have announced that they are set to begin clinical testing of their recombinant protein-based COVID-19 vaccine in humans.
The partner drugmakers will study the vaccine candidate in 440 health adults in the US, and will evaluate the safety, immune response and tolerability of the shot.
The vaccine combines Sanofi’s baculovirus expression system, which is already used in its quadrivalent flu vaccine, and GSK’s AS03 adjuvant, which is designed to boost immune responses in participants.
Sanofi and GSK expect the first results from the clinical trial in early December, which will hopefully support the launch of a large-scale phase 3 trial in the same month.
“Sanofi and GSK bring proven science and technology to the fight against the global COVID-19 pandemic, with the shared objective of delivering a safe and effective vaccine. 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, executive vice president and global head of Sanofi Pasteur.
“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.
Sanofi and GSK announced their partnership in April, and at that time the companies said they expect to complete the development required for availability by the second half of 2021.
In July, the UK government agreed a deal with the drugmakers for 60 million doses of the protein-based vaccine. The deal ensures early access to the COVID-19 vaccine if it proves effective in clinical trials, with the first doses going to priority groups.
A week later, Sanofi and GSK forged another agreement with the US government for 100 million doses of their vaccine. The companies were also selected to be included in Operation Warp Speed, a targeted initiative which aims to deliver 300 million doses of a COVID-19 vaccine to American citizens, free of charge, by January 2021.
As part of this agreement, the US government is set to provide up to $2.1bn to support development of the vaccine, including clinical trails, the manufacturing scale-up and delivery of the initial 100 million doses.