GlaxoSmithKline (GSK) and Canadian biopharma company Medicago have launched a Phase III trial of their adjuvanted plant-derived COVID-19 vaccine candidate.
The vaccine candidate uses Coronavirus-Like-Particle (CoVLP) technology, composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) administered alongside GSK’s pandemic adjuvant.
Medicago said it has received approval from Canadian and US regulatory authorities to begin enrolment of healthy adults into the Phase III trial based on ‘positive interim Phase II results’.
The adjuvanted plant-derived vaccine candidate received a fast track designation from the US Food and Drug Administration (FDA) in February 2021.
The Phase III portion of the study will evaluate the efficacy and safety of the adjuvanted CoVLP formulation and will enrol up to 30,000 participants.
Initially, the trial will enrol healthy adults aged 18 to 65 years old, followed by elderly adults aged 65 and over and adults with comorbidities.
The companies added that the Phase II trial of the vaccine is nearing completion, with results expected to be made public in April 2021.
“We are pleased to take the significant step of initiating the Phase III clinical trial at sites around the world,” said Takashi Nagao, chief executive officer and president of Medicago.
“This brings us one step closer to delivering an important new COVID-19 vaccine and contributing to the global fight against the pandemic along with our partner GSK,” he added.