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, 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.
On March 16, 2021, Takashi Nagao, CEO, and President of Medicago, stated in a press release, “We are pleased to take the significant step of initiating the Phase 3 clinical trial at sites around the world. This brings us one step closer to delivering an important new COVID-19 vaccine and contributing to the global fight against the pandemic along with our partner GSK.”
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
March 16, 2021 - Medicago and GlaxoSmithKline (GSK) announced the start of Phase 3 clinical testing of Medicago's plant-derived COVID-19 vaccine candidate combined with GSK's pandemic adjuvant as part of the ongoing Phase 2/3 study. Medicago received approval from Canadian and US regulatory authorities to proceed with the enrollment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. In parallel, Medicago has also initiated a vaccine candidate's feasibility study to address the emerging COVID-19 variants.
February 17, 2021 - The vaccine candidate, combined with the pandemic adjuvant, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Fast Track designation allows the FDA to expedite the development and review of new medicines and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
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.
November 10, 2020 - 100 percent of subjects who received an adjuvanted vaccine candidate developed significant antibody and cellular immune responses after two doses.
November 6, 2020 - Non-peer-reviewed study: Phase 1 trial of a Candidate Recombinant Virus-Like Particle Vaccine for Covid-19 Disease Produced in Plants. Conclusion CoVLP ± adjuvants was well-tolerated. Several adjuvanted formulations elicited strong humoral and T cell responses after dose 2. Even at the lowest CoVLP+AS03 dose, NtAb titers were ∼10-times higher than in convalescent serum with a balanced IFNγ and IL-4 response. These findings support the transition of CoVLP (3.75μg+AS03) to further clinical evaluation.
October 23, 2020 - Medicago announced that it had reached an agreement to supply Canada's Government 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 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 evaluates 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 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 had 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 Trials
Clinical Trial NCT04636697: Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults. This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile.
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 the safety and durability of the immune responses to the vaccine candidate.
The Phase 3 portion of the study is an event-driven, randomized, observer-blinded, placebo-controlled, two-way cross-over design that will evaluate the efficacy and safety of the adjuvanted CoVLP formulation compared to placebo. The study will enroll up to 30,000 subjects initially composed of healthy adults (18y to 65y), followed by elderly adults (65y+) and adults with comorbidities. The trial will occur in 10 countries pending regulatory approvals, starting with Canada and the United States, and will enroll males and females from ethnically and racially diverse populations. Information about how to participate in this clinical trial is available here.
Clinical Trial NCT04450004: Safety, Tolerability, and Immunogenicity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years.
- 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 supports 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.”