Sanofi and GSK announced the initiation of a new phase II study to select the most appropriate antigen dosage for phase III evaluation of their adjuvanted recombinant protein COVID-19 vaccine.

Sanofi and GSK announced the initiation of a new Phase II study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase III evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate In parallel to the new Phase II study and recognizing the global emergence of new SARS-CoV-2 variants and their potential impact on vaccine efficacy, Sanofi has commenced development work against new variants, which will be used to inform next stages of the Sanofi/GSK development program. About the Phase II study : The new Phase II trial is a randomized, double-blind, multi-center dose finding study conducted in adults aged 18 years of age and older to evaluate the safety, reactogenicity, and immunogenicity of two injections given 21 days apart. The trial will include equal numbers of adults 18 to 59 years and those 60 years and above.Three different antigen doses with a fixed dose of adjuvant will be tested in a total study population of 720 volunteers, in the United States, Honduras and Panama. Results of the Phase II trial will inform the Phase III protocol. In December 2020, Phase 1/II study results showed an immune response comparable to patients who had recovered from COVID-19 in adults aged 18 to 49 years, but a lower immune response in older adults, likely due to an insufficient concentration of the antigen. If data from the new Phase II trial are positive, a global Phase III study is planned for Q2 2021. Positive results from the Phase III study would lead to regulatory submissions in the second half of 2021, with the vaccine expected to be available in Q4 2021, if approved. In parallel to the new Phase II study and recognizing the global emergence of new SARS-CoV-2 variants and their potential impact on vaccine efficacy, Sanofi has commenced development work against new variants, which will be used to inform next stages of the Sanofi/GSK development program.