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GSK, Medicago launch phase 2/3 clinical trials of plant-derived COVID-19 vaccine

Vaccine candidate yielded positive phase 1 results

GlaxoSmithKline (GSK) and Medicago have are set to launch phase 2/3 trials of a plant-derived COVID-19 vaccine candidate, after the shot yielded positive results in phase 1.

The vaccine candidate combines Medicago’s recombinant coronavirus virus-like particles (CoVLP) with GSK’s pandemic adjuvant system.

Medicago’s CoVLPs mimic the structure of the SARS-CoV-2 virus that causes COVID-19, which allows them to be recognised and targeted by the immune system.

In an early study of the vaccine, Canada-headquartered Medicago said that all subjects vaccinated with the experimental shot developed "a promising antibody response after two doses".

The company added that it will use a lower dose of the vaccine, combined with GSK’s adjuvant, in the upcoming phase 2/3 studies. Adjuvants are typically used to boost the immune response of a specific vaccine candidate.

They are of particular use in a pandemic situation, as the boosted immune response can reduce the amount of antigen required per dose, allowing for more vaccine doses to be manufactured and distributed.

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

Each age group – 18-64 years and over 65 years – will have over 300 subjects randomised to receive the adjuvanted CoVLP vaccine or placebo.

The phase 3 study portion, which is set to begin before the end 2020, will evaluate the efficacy and safety of the CoVLP formulation compared to placebo in over 30,000 subjects.

“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,” said Thomas Breuer, chief medical officer, GSK Vaccines.

“We are delighted with the very promising phase 1 results of Medicago’s COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant,” he added.

GSK has already offered its pandemic adjuvant system in previous deals focused on targeting COVID-19, including a collaboration with Sanofi for a recombinant protein-based vaccine.

Sanofi and GSK initiated a phase 1/2 study of the vaccine candidate in September and anticipate first results in early December, to support a phase 3 study launch before the end of the year.

Another deal was also agreed in February with China-based Clover Pharmaceuticals that saw GSK’s adjuvant platform utilised for the development of the biotech’s coronavirus vaccine candidate, COVID-19 S-Trimer.

On 25 September, Clover said that it intends to start a phase 2/3 trial of S-Trimer before the end of 2020.

Article by
Lucy Parsons

12th November 2020

From: Research



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