GlaxoSmithKline (GSK) has initiated the Phase 1/2 clinical trial of the adjuvanted Covid-19 vaccine, which has been developed by the company in partnership with French pharmaceutical firm Sanofi.

The vaccine candidate has been developed leveraging the recombinant protein-based technology, similar to the Sanofi’s seasonal influenza vaccines, with GSK’s pandemic adjuvant technology.

In the pre-clinical studies, two injections of the adjuvanted recombinant vaccine showed an acceptable reactogenicity profile, and elevated levels of neutralising antibodies, similar to that of people who recovered from the Covid-19 infection.

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.

“This builds on the confidence shown by governments already in the potential of this protein-based adjuvanted vaccine candidate, which utilises established technology from both companies and can be produced at scale by two of the leading vaccine manufacturers globally.

“We now look forward to the data from the study, and if positive, beginning a Phase 3 trial by the end of the year.”

Sanofi and GSK are scaling up manufacturing of the components for Covid-19 vaccine

The Phase 1/2 study is a randomised, double-blind and placebo-controlled clinical trial, designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the Covid-19 vaccine candidate, a total of 440 healthy adults, enrolled across 11 investigational sites in the US.

Early results from the study are expected in early December 2020, which would support the beginning of Phase 3 trial, and the company intends to seek regulatory approval in the first half of 2021 if the data are sufficient for the application.

Furthermore, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant, with an aim to manufacture up to one billion doses in 2021.

The Biomedical Advanced Research and Development Authority (BARDA) has provided funding support for the development of the adjuvanted Covid-19 vaccine candidate.

Sanofi Pasteur executive vice president and global head Thomas Triomphe said: “Sanofi and GSK bring proven science and technology to the fight against the global Covid-19 pandemic, with the shared objective of delivering a safe and effective vaccine.

“The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat Covid-19.

“Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December. Positive data will enable a prompt start of the pivotal phase 3 trial by the end of this year.”