GSK and Sanofi Launch Phase 2 Vaccine Study After Delay
GlaxoSmithKline (GSK) and Sanofi have launched a phase 2 study evaluating their adjuvanted recombinant COVID-19 candidate, after delaying the trial by more than two months.
The trial will enroll 720 volunteers aged 18 years and older to determine the “most appropriate antigen dosage” for an upcoming phase 3 study, the companies said Monday.
In December, GSK and Sanofi suffered a setback during their phase 1/2 trial, when their vaccine was found to produce only a weak immune response in older patients.
But the companies claim they have refined the vaccine’s antigen formulation and hope to launch a phase 3 trial during the second quarter of this year, with a potential vaccine rollout occurring during the last quarter of 2021, contingent upon regulatory approval.