Sanofi and GSK have announced the commencement of Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine.
The vaccine candidate that was developed by both firms uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology.
The companies in a statement said that the Phase 1/2 clinical trial is a randomised, double blind and placebo-controlled trial.
It is designed to evaluate the safety, reactogenicity and immunogenicity of the vaccine candidate.
They added that a total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the United States.
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, we are planning to request regulatory approval in the first half of 2021,” the statement said.
Speaking on the development, Executive Vice President and Global Head of Sanofi Pasteur, 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.”
Also speaking, President of GSK Vaccines, 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 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.