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Plant-Based COVID-19 Vaccine Candidate Starts Phase 3 Trial
Saturday, 2021/04/03 | 06:30:36

Photo Source: Medicago.

 

Medicago, the Quebec City-based biopharmaceutical company, and GlaxoSmithKline (GSK) have announced the start of Phase 3 clinical testing of Medicago's plant-derived COVID-19 vaccine candidate in combination with GSK's pandemic adjuvant, as part of the ongoing Phase 2/3 study.

 

Medicago received approval from Canadian and US regulatory authorities to proceed with the enrollment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. The vaccine candidate, in combination with the pandemic adjuvant, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) on February 17, 2021. Fast Track designation allows the FDA to expedite the development and review of new medicines and vaccines intended to treat or prevent serious conditions and address an unmet medical need.

 

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 enroll 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 enroll males and females from ethnically and racially diverse populations. Medicago's plant-derived COVID-19 vaccine candidate 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 3.75 micrograms of CoVLP are administered 21 days apart.

 

For more details, read the media release from Medicago.

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