London: Global healthcare companies Sanofi and GSK today announced the start of the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine.
The vaccine candidate, developed in partnership by Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology.
The Phase 1/2 clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the COVID-19 vaccine candidate.
A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the United States, a company statement of GSK said.
The companies anticipate first results in early December 2020, to support the initiation of a Phase 3 trial in December 2020. If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021.
Sanofi is leading the clinical development and registration of the COVID-19 vaccine. Pre-clinical data showed an acceptable reactogenicity profile and data based on two injections of the adjuvanted recombinant vaccine showed high levels of neutralising antibodies that are comparable to levels in humans who recovered from the COVID-19 infection. Pre-clinical results will be published later this year. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021.