GSK and Sanofi to begin new Phase II trial of their COVID-19 vaccine

pharmafile | February 22, 2021 | News story | Sales and Marketing COVID, COVID Vaccine, COVID-19, GSK, Sanofi 

GlaxoSmithKline (GSK) and Sanofi are set to begin a new Phase II study of their COVID-19 vaccine candidate, following setbacks that delayed the vaccine last year.

The trial will involve 720 volunteers aged 18 years and over, and will allow researchers to select the most appropriate antigen dosage for Phase III evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.

The randomised, double-blind, multi-centre trial in adults from the US, Honduras, and Panama will measure the safety, reactogenicity, and immunogenicity of two injections given 21 days apart. Half the participants will be older than 60 years.

This follows an announcement in December that the shot would have to be delayed after studies showed the vaccine to give an insufficient immune response in older participants.

Phase III testing will begin in the second quarter of this year, if the Phase II study is successful.

Sanofi has also commenced development work against new variants of coronavirus, which will be used to inform the next stages of the Sanofi-GSK vaccine development programme.

Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur, said: “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 I/II study. We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data.

“This new Phase II 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.”

Roger Connor, President of GSK Vaccines, added: “We are pleased to be starting this new Phase II study. The world needs multiple vaccines and we are confident that combining our proven pandemic adjuvant system with this improved antigen formulation will have significant potential as the pandemic evolves.”

Jack Goddard

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