Medicago and GlaxoSmithKline (GSK) have reported 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 I testing.
Immunogenicity, as measured by the neutralizing 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 Phase III trial of the vaccine candidate launched on March 16, 2021. Trial sites are currently enrolling 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.
Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago said: “We are very excited to see such positive results from the Phase II data. After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespectively of age. These results give us confidence as we continue to move forward with our Phase III clinical trial. We hope to add another tool in the global fight against COVID-19, particularly as cross-protection emerges as an important consideration in vaccination efforts worldwide.”
Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “We are delighted to see that the results suggest a very strong immune response, Medicago’s COVID-19 vaccine candidate combined with GSK’s pandemic adjuvant was also well tolerated, reinforcing its potential benefits. We now look forward to the outcome of the ongoing Phase 3 trial of this refrigerator-stable vaccine candidate as the next step forward in our contribution to the global response to the pandemic.”