Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.
The randomised, double blind and placebo-controlled trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the experimental COVID-19 vaccine candidate.
First results are expected early December and, if positive, will pave the way for initiation of a Phase III trial in the same month. If successful, the companies intend to request regulatory approval in the first half of 2021.
Preclinical data – due to be published later this year – show an acceptable reactogenicity profile following two injections of the adjuvanted recombinant vaccine, and high levels of neutralising antibodies comparable to levels in humans who recovered from COVID-19 infection.
Sanofi and GSK are currently scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021.
“The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat COVID-19,” said Thomas Triomphe, executive vice president and Global head of Sanofi Pasteur. “Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December.”
Roger Connor, President of GSK Vaccines, added: “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.”
Development of the vaccine is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
By: Selina McKee
Source: Pharma Times
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