GlaxoSmithKline and Sanofi on Monday announced the start of a new Phase 2 trial involving their protein-based COVID-19 vaccine candidate after facing a setback in December. The companies had said previous trials showed an insufficient immune response in older people which sent them back to the drawing board.
In a news release posted Monday, the companies announced the initiation of a new Phase 2 study involving 720 volunteers ages 18 and older, which they hope will help determine the appropriate antigen dosage for Phase 3 evaluation.
“Over the past few weeks, our teams have worked to refine the antigen formulation of our recombinant-protein vaccine, based on learnings from our initial Phase 1/2 study,” Thomas Triomphe, executive vice president and head of Sanofi Pasteur, said in the news release. “We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data. This new Phase 2 study will enable us to identify the final vaccine formulation for adults of all ages. We have demonstrated our commitment to focusing efforts and capabilities towards the global fight against the pandemic, and this new study takes us a step closer to achieving our primary goal of developing a COVID-19 vaccine with a good efficacy and safety profile.”
The companies are hopeful that if the trial results are positive, Phase 3 can begin in the second quarter of 2021, putting the vaccine on track to be available in the fourth quarter.
The news release said Sanofi has also commenced development work against new variants.