Based on positive phase I clinical trial results, Medicago decided to launch the phase II/III trial with GSK's pandemic adjuvant.
The candidate, coronavirus-like particle (CoVLP), is composed of a recombinant spike glycoprotein expressed as virus-like particles. The candidate will be given in combination with GSK's pandemic adjuvant which offers dose sparing and high immune response.
In the study, the companies will confirm the chosen formulation and dose regimen of CoVLP (two doses of 3.75 µg of CoVLP combined with the adjuvant given 21 days apart).
The phase II trial is a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant vaccine in subjects over 18 years of age (adults 18-64 years and individuals over 65 years). It will be conducted in sites in Canada and the U.S. All subjects will be followed for a period of 12 months after the last vaccination.
The phase III part of the study will begin before the end of 2020 and is an event-driven, randomized, observer-blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation compared to placebo in over 30,000 subjects in North America, Latin America, and/or Europe and within the same population as the phase II portion or amongst a broader one pending approval by regulatory authorities.
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