Sanofi and GSK launch phase II study of their COVID-19 vaccine candidate

Sanofi and GlaxoSmithKline (GSK) announced the launch of a new Phase II study of their adjuvanted COVID-19 recombinant protein vaccine candidate.

The phase II trial is a randomized, double-blind, multicenter, dose-finding study and will evaluate the safety, reactogenicity and immunogenicity of two injections of the vaccine administered 21 days apart in 720 volunteers aged 18 years. and more. He will evaluate three different antigen doses with a fixed adjuvant dose in order to select the most appropriate dose of antigen for phase III evaluation.

Importantly, the companies said, the trial will include an equal number of adults aged 18 to 59 and 60 and older. This helps ensure that the selected dose works well for all ages, as phase I / II data released in December 2020 indicated that adults aged 50 and older had a weaker immune response to the vaccine than those aged 50 and over. 18 to 49 years old. The companies said this was most likely due to insufficient concentration of the antigen.

“Over the past few weeks, our teams have been working to refine the antigenic formulation of our recombinant protein vaccine, based on lessons learned from our initial Phase I / II study,” said Thomas Triomphe, Executive Vice President and Director by Sanofi Pasteur. “We are convinced that our vaccine candidate has great potential and we are very encouraged by the latest preclinical data. This new phase II study will allow us to identify the definitive formulation of the vaccine for adults of all ages. We have demonstrated our commitment to focus our efforts and capabilities on the global fight against the pandemic, and this new study brings us closer to achieving our primary goal of developing a COVID-19 vaccine with a good efficacy profile and harmlessness.

The companies added that, if the data from the new phase II trial is positive, a global phase III study is expected to start in the second quarter of 2021. The positive results of the phase III study would lead to regulatory submissions in the second half of the year. 2021., the vaccine is expected to be available in the fourth quarter of 2021, if approved.

In addition to the new trial, Sanofi has started work on developing vaccines that can fight emerging strains of SARS-CoV-2 that may impact vaccine efficacy. This research will be used to inform the next steps in the Sanofi / GSK development program.