Topline findings from interim Phase 2 trial results include:
- All subjects who received an adjuvanted vaccine candidate developed significant antibody and cellular immune responses after two doses
- Similar antibody responses were observed in adults and in the elderly
- There were no severe adverse events reported
- The reactogenicity events were generally mild to moderate and short in duration
Phase 3 trials of the vaccine candidate got underway in March, with trial sites in Canada, US, Brazil, and the UK, and addition study locations to come on stream in the coming weeks.
“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, scientific and medical affairs at Medicago. “These results give us confidence as we continue to move forward with our Phase 3 clinical trial.”
Thomas Breuer, chief medical officer, GSK Vaccines, said 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.”