CoVLP SARS-CoV-2 Vaccine Description
The CoVLP SARS-CoV-2 vaccine uses living plants as bioreactors to produce non-infectious versions of viruses (called Virus-like Particles, or VLP). VLPs mimic the architecture of a virus but are non-infectious.
The technology Proficia® uses N. benthamiana plants, which is the most widely used experimental host in plant virology, due mainly to the large number of viruses that can successfully infect it. Its weakened immune system, the result of natural genetic changes over millennia, means genetic material can be successfully hosted by the plant and not rejected.
The VLPs present antigens to the individual's immune system in a highly efficient manner, eliciting a protective and long-lasting immune response.
VLPs mimic the native structure of viruses, allowing them to be easily recognized by the immune system. However, they lack core genetic material which makes them non-infectious and unable to replicate. In other words, they induce an immune response similar to a natural infection but without the inconveniences associated with it. VLPs can also be engineered to have antigens attached for use in vaccines or other immunotherapies, says the company.
Located in Quebec City, Canada, Medicago is a biopharmaceutical company and pioneer in plant-based therapeutics technology. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare.
CoVLP SARS-CoV-2 Vaccine Indication
CoVLP SARS-CoV-2 vaccine is indicated to prevent COVID-19 disease which is caused by the SARS-CoV-2 virus.
No pediatric vaccine efficacy has been disclosed.
CoVLP SARS-CoV-2 Vaccine News
November 12, 2020 - Medicago and GSK announce the start of Phase 2/3 clinical trials of its plant-derived vaccine candidate for COVID-19 to evaluate its efficacy, safety, 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.
Thomas Breuer, Chief Medical Officer GSK Vaccines said “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. We 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 us confident of delivering an efficacious vaccine with an acceptable safety profile in collaboration with Medicago.”
November 10, 2020 - 100 percent of subjects who received an adjuvanted vaccine candidate developed significant antibody and cellular immune responses after two doses.
October 23, 2020 - Medicago announced that it has reached an agreement to supply the Government of Canada with up to 76 million doses of its vaccine against COVID-19, subject to Health Canada approval. Medicago will also receive $173M in funding support from the Government of Canada for its vaccine research and development, and for the construction of its Quebec City manufacturing facility.
July 14, 2020 - Medicago began Phase I clinical trials for its plant-derived COVID-19 vaccine candidate yesterday, administering the first doses in healthy human volunteers. Medicago is also planning a Phase 2/3 trial to be initiated in October 2020.
July 8, 2020 - Dynavax Technologies Corporation and Medicago, a biopharmaceutical company creating vaccines and therapeutics by leveraging innovative plant-based technologies, today announced their collaboration to investigate an adjuvanted vaccine candidate to protect against COVID-19. The collaboration is evaluating the combination of Medicago's Coronavirus Virus-Like Particle (CoVLP) with Dynavax's advanced adjuvant, CpG 1018™. Adding CpG 1018, the adjuvant contained in Dynavax's U.S. FDA-approved adult hepatitis B vaccine, is intended to enhance the immune response of Medicago's COVID-19 vaccine which may decrease the total amount of antigen needed per dose, providing more doses to help protect a greater number of people.
March 12, 2020 - Medicago said it has produced a virus-like particle of the novel coronavirus, a first step towards producing a vaccine, which will now undergo pre-clinical testing for safety and efficacy.
CoVLP SARS-CoV-2 Vaccine Clinical Trial
Breaking news: The Phase 2 trial part is a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-derived vaccine candidate in subjects aged 18 and above. It will be conducted in multiples sites in Canada and, upon FDA allowance, in the United States and on a population composed of healthy adults (18-64y) and elderly adults (over 65y). Each age group will have over 300 subjects randomized 5:1 to receive the adjuvanted CoVLP vaccine candidate: placebo and with 2:1 stratification in older adults (65-74 and ≥75). All subjects will be followed for a period of 12 months after the last vaccination for the assessment of safety and durability of the immune responses to the vaccine candidate.
Clinical Trial NCT04450004: Safety, Tolerability, and Immunogenicity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years. Last Update Posted: October 23, 2020.
- The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in healthy adults 18 to 55 years of age, who have been tested for the absence of SARS-CoV-2 antibodies.
- The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people.
- Results: After 2-doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses which is encouraging and support further clinical evaluation,” said Nathalie Landry, Executive Vice President, Scientific, and Medical Affairs at Medicago. “We also observed that the antibody levels were higher after vaccination than those observed in convalescent sera from people who recovered from the disease.”