Medicago and GSK announce positive interim Phase II results for adjuvanted COVID-19 vaccine candidate.

Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline are pleased to report positive interim Phase II clinical trial safety and immunogenicity data for Medicago’s plant-derived COVID-19 vaccine candidate, which has been tested in combination with GSK’s pandemic adjuvant. These results are part of the ongoing Phase II/III study and reiterate the promising profile observed during Phase 1 testing. Immunogenicity, as measured by the neutralising antibody titer, was high: about 10 times higher than those in a panel of sera from patients recovering from COVID-19. No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration. The interim data from Phase II in adults and in the elderly have been published on an online preprint server at MedRxiv. i. This publication focuses on presenting safety and tolerability results, and immunogenicity, as measured by neutralizing antibody (NAb) and cell mediated immunity (IFN-y and IL-4 ELISpot) responses, in adults aged 18-64 (adults) and older adults aged 65+ (older adults). ii.Medicago’s vaccine candidate with GSK’s pandemic adjuvant exhibited an acceptable safety profile and adverse events (AEs) were primarily mild or moderate and of transient duration. iii.AEs in older adults were more limited than those observed in the adult population. iv.Medicago’s vaccine candidate with GSK’s pandemic adjuvant induced a significant humoral immune response of similar strength in both age cohorts after two doses. v. The vaccine candidate induced a greater humoral response in adults than older adults after a single dose but after the second dose both age cohorts responded with NAb titers that were about 10 times higher than those in a panel of sera from patients recovering from COVID-19.