Global vaccine giants Sanofi and GSK have initiated the phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine.
The vaccine candidate is developed in partnership by Sanofi and GSK. It uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s pandemic adjuvant technology.
In July 2020, Sanofi and GSK announced a collaborative effort with the US government to supply up to 100 million doses of their COVID-19 recombinant protein-based vaccine to meet the US government’s Operation Warp Speed.
A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the US to evaluate the safety and immunogenicity of the vaccine in a randomised, double-blind and placebo- controlled trial.
The companies anticipate first results of the vaccine by early December 2020 and plan to start a phase 3 trial in the same month. They expect to file for regulatory approval in the first half of 2021.
Sanofi is leading the clinical development and registration of the COVID-19 vaccine. Preclinical 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.