French pharmaceutical firm Sanofi and British drugmaker GlaxoSmithKline (GSK) have commenced the phase 1/2 clinical of the Covid-19 adjuvanted recombinant protein-based vaccine candidate.
Both firms have worked together to develop a vaccine candidate, which applies the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s pandemic adjuvant technology.
Sanofi Pasteur global head and executive vice president Thomas Triomphe said: “The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat Covid-19.”
The randomized, double-blind and placebo-controlled trial will assess the safety, reactogenicity (tolerability), and immunogenicity (immune response) of the Covid-19 vaccine candidate.
Sanofi and GSK will recruit up to 440 healthy adults in the phase 1/2 clinical study across 11 investigational sites in the US.
Both firms expect initial data from the trial this December, which will be used to begin a phase 3 trial during the same month.
The companies intend to apply for regulatory approval in the first half of 2021 if sufficient data is generated for licensure application,
Sanofi is taking responsibility for the clinical development and registration of the Covdi-19 vaccine.
According to Sanofi, preclinical data demonstrated an acceptable reactogenicity profile, and data based on two injections of the adjuvanted recombinant vaccine showed significant levels of neutralizing antibodies that are comparable to levels in humans who recovered from the Covid-19 infection.
Simultaneously, both companies will also scale up the production of the antigen and adjuvant with an aim to manufacture up to one billion doses next year.
GSK Vaccines president Roger Connor said: “Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing.”
In August, Sanofi and GSK announce a collaborative effort with the US government to advance the development and manufacturing of a Covid-19 recombinant protein-based vaccine.