Medicago and GSK have announced the beginning of Phase 2/3 clinical trials of plant-derived vaccine candidate for Covid-19.
The study is being done to assess its safety, efficacy and immunogenicity. Based on the positive Phase 1 results and the approval of Canadian regulatory authorities, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant.
While Medicago is a biopharmaceutical company headquartered in Quebec City, GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago, said, “Ourr Phase 1 results of the adjuvanted vaccine candidate were very encouraging and fully support further clinical evaluation.”
According to Thomas Breuer, Chief Medical Officer GSK Vaccines, “This is the first of several GSK Covid-19 vaccine candidate collaborations to start Phase 2/3 clinical testing and an important step forward in our contribution to the global fight against the pandemic.”
Promising Phase 1 results
He said they are delighted with the very promising Phase 1 results of Medicago’s Covid-19 vaccine candidate in combination with GSK’s pandemic adjuvant.
Proven dose-sparing and a high immune response due to GSK’s adjuvant make them confident of delivering an efficacious vaccine with an acceptable safety profile in collaboration with Medicago, Breuer added.
The Coronavirus-Like Particle Covid-19 vaccine candidate, shortly CoVLP, is composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs).
The research is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP- 2 doses of 3.75 µg CoVLP combined with GSK’s pandemic adjuvant given 21 days apart.
It has an acceptable immunogenicity and safety profile in healthy adults in the age-group of 18 to 64 years and in elderly subjects aged 65 and above.