Medicago’s plant-derived vaccine candidate against COVID-19 uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GSK’s pandemic adjuvant. Two doses of 3.75μg of CoVLP are administered 21 days apart.
The Phase 3 portion of the study is an event-driven, randomized, observer-blinded, placebo-controlled, two-way cross-over design that will evaluate the efficacy and safety of the adjuvanted CoVLP formulation, compared to placebo. The study will enrol up to 30,000 subjects initially composed of healthy adults (18y to 65y) followed by elderly adults (65y+) and adults with comorbidities. The trial will take place in 10 countries pending regulatory approvals, starting with Canada and the United States, and will enrol males and females from ethnically and racially diverse populations.
The Phase 2 portion of the trial is approaching completion and results are expected to be made publicly available in April 2021.
SK bioscience and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine candidate