Biopharmaceutical company Medicago has reported interim results of the Phase I clinical trial of the plant-derived vaccine for Covid-19.
The study results indicated that all subjects showed a promising antibody response following two doses of the firm’s Covid-19 adjuvanted vaccine candidate.
Medicago scientific and medical affairs executive vice-president Nathalie Landry said: “These are very promising results. After two doses, the adjuvanted vaccine candidate induced robust neutralising antibody and cellular immune responses, which is encouraging and support further clinical evaluation.
“We also observed that the antibody levels were higher after vaccination than those observed in convalescent sera from people who recovered from the disease.”
No severe adverse events were found during the trial, while reactogenicity events were found to be not just generally mild to moderate, but also short in duration.
Phase I is a randomised, partially blinded trial involving 180 healthy subjects of males and females in the age group of 18 to 55 years.
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The study evaluated dosages of 3.75, 7.5 or 15 micrograms of the recombinant Coronavirus Virus-Like Particle (CoVLP) vaccine candidate only or in a prime-boost regimen with an adjuvant.
A liquid formulation, CoVLP can be stored at 2°C to 8°C.
The firm tested the vaccine candidate with each of the two adjuvants, one with GSK’s pandemic adjuvant technology, and the other with Dynavax’s CpG 1018.
During the study, the humoral and cell-mediated immune responses were found with both adjuvants.
Backed by the Phase I data, Medicago intends to go ahead with the Phase II/III clinical trial of its Covid-19 vaccine candidate, subject to approval from regulatory authorities.
Medicago president and CEO Dr Bruce D Clark said: “The positive results of our Phase I clinical trial are a step forward in the fight against the Covid-19 pandemic and we are confidently moving forward to our Phase II/III trial.
“We’re pleased that Medicago’s innovative manufacturing technology is helping to diversify the classes of Covid-19 vaccines candidates in development. In addition to supplying up to 76 million doses to the Government of Canada, we are ready to participate globally in the fight against Covid-19.
“We would like to express our gratitude to the clinical trial participants who have generously dedicated their time to support the advancement of Medicago’s Covid-19 vaccine candidate. We also would like to extend our thanks to our partners GSK and Dynavax, as well as the clinical investigators.”