GSK, Sanofi Kick Off Phase 2 Vaccine Trial Following December 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.
Specifically, the study will evaluate a two-dose regimen administered 21 days apart for safety, reactogenicity and immunogenicity in the U.S., Honduras and Panama. The companies also say they have begun work on targeting coronavirus variants.
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 (DID, Dec. 14, 2020).
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.
Sanofi also announced Monday it would help Johnson & Johnson produce its vaccine starting the third quarter of this year, at the rate of 12 million doses per month.
And Sanofi said in late January that it would perform late-stage manufacturing of Pfizer/BioNTech’s vaccine starting this summer to help supply the EU with more than 125 million doses. ― Jason Scott