Quebec City-based Medicago and GlaxoSmithKline (GSK) have announced the positive interim Phase 2 clinical trial safety and immunogenicity data for Medicago’s plant-derived COVID-19 vaccine candidate, which was tested in combination with GSK’s pandemic adjuvant. These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.
The results show that immunogenicity, as measured by the neutralizing antibody titer, was high at 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. “We are very excited to see such positive results from the Phase 2 data.
After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespectively of age,” said Nathalie Landry, Executive Vice President of Scientific and Medical Affairs at Medicago. The Phase 3 trial of Medicago’s vaccine candidate was launched on March 16, 2021. Trial sites include subjects in Canada, the United States, the United Kingdom, and Brazil, with additional sites expected to be added in the coming weeks. The vaccine candidate has received Fast Track designation by the FDA in the United States, and Health Canada has initiated a review of Medicago’s COVID-19 rolling submission under the Interim Order.