Pharmaceutical giants, Sanofi and GlaxoSmithKline have jointly announced the commencement of phase II clinical trial for an adjuvant COVID-19 vaccine.
The vaccine candidate, jointly developed by the two global companies, uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology.
In a recent statement, President of GSK Vaccines, Roger Connor, disclosed that the randomised, double-blind and placebo-controlled clinical trial was designed to evaluate the safety, tolerability and immune response of the COVID-19 vaccine candidate.
“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 adjuvant vaccine candidate, which utilises established technology from both companies.
“We now look forward to the data from the study, and if positive, beginning a phase III trial by the end of the year,” he said.
A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the United States.
Connor disclosed that both companies anticipate the first results in early December 2020, to support the initiation of a Phase III 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,” he said.
The Executive Vice President and Global Head of Sanofi Pasteur, Thomas Triomphe equally noted that Sanofi and GSK have brought proven science and technology to fight the global pandemic as well as to deliver 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,” he said.
Triomphe further stressed that both pharma giants are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021