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Medicago, GSK Start Phase 2/3 Trials Of Adjuvanted COVID-19 Vaccine Candidate

Medicago said that it has decided to start phase 2/3 clinical trials of its plant-derived vaccine candidate for COVID-19 to evaluate its efficacy, safety, and immunogenicity. The COVID-19 vaccine candidate will contain GlaxoSmithKline plc.'s (GSK.L,GSK) pandemic adjuvant.

The move was based on the positive Phase 1 results and the approval of Canadian regulatory authorities.

Thomas Breuer, Chief Medical Officer GSK Vaccines said "...We are delighted with the very promising Phase 1 results of Medicago's COVID-19 vaccine candidate in combination with GSK's pandemic adjuvant."

The Coronavirus-Like Particle COVID-19 vaccine candidate, CoVLP is composed of recombinant spike (S) glycoprotein expressed as virus-like particles or VLPs.

According to the company, the study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP (two doses of 3.75 µg CoVLP combined with GSK's pandemic adjuvant given 21 days apart) has an acceptable immunogenicity and safety profile in healthy adults 18-64 years of age and in elderly subjects aged 65 and over.

The Phase 2 trial will evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-derived vaccine candidate in subjects aged 18 and above.

Medicago noted that the phase 3 part of the study should start before the end of 2020. The phase 3 clinical trial will enroll over 30,000 volunteers worldwide.

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