Biology:CoVLP
Vaccine description | |
---|---|
Target disease | SARS-CoV-2 |
Type | vlp |
Clinical data | |
Routes of administration | Intramuscular |
Identifiers | |
DrugBank |
CoVLP is a COVID-19 vaccine candidate developed by Medicago and GlaxoSmithKline (GSK). It is a coronavirus virus-like particle vaccine grown in the Australian weed, Nicotiana benthamiana.[1][2][3]
The Medicago method to manufacture CoVLP is a "molecular farming" technology regarded as rapid, low-cost, and safe.[1][4] It has been proposed specifically for production of COVID-19 vaccines.[5][6]
As of January 2021, the Medicago CoVLP vaccine candidate was in a Phase II-III clinical trial in Canada and the United States, involving 30,918 participants.[7]
Technology
CoVLP is an example of a virus-like particle vaccine, consisting of a molecular complex which closely resembles a virus, but is non-infectious because its contains no viral genetic material.[1] It uses recombinant spike proteins derived from SARS-CoV-2.[8][9]
The virus-like particles are produced by creating a bacterium engineered with genes of the virus, then introducing the bacteria into Nicotiana benthamiana plants.[1] The plants take up the bacteria virus-derived generic material, producing in its leaves the virus-like particles, which are then harvested and extracted.[3][10]
In use since the 1990s, the method of using a plant like N. benthamiana has been called "molecular farming" or a "plant-based factory", having vaccine manufacturing advantages of rapid, low-cost production of proteins, large scalability for production, and safety of using plants for pharmaceutical production.[1][4] It has been proposed specifically for production of COVID-19 vaccines.[5][6]
Development
Medicago is developing the COVID-19 vaccine candidate, CoVLP, in collaboration with the governments of Canada and Quebec, and by using an adjuvant manufactured by GlaxoSmithKline (GSK).[8] The GSK adjuvant is intended to enhance the immune response to CoVLP, reducing the amount of antigen required per dose, thereby facilitating mass production of vaccine doses.[11][12]
Clinical research
Phase I
Beginning in August 2020, coVLP was in a Phase I clinical trial at two locations in Quebec to evaluate its safety and immune response.[13]
Phase II-III
In November 2020, Medicago-GSK started a Phase II-III clinical trial for CoVLP, enrolling 30,918 participants in three Canadian provinces and three locations in the United States.[7][9] The Phase II-III trial has a primary completion date of December 2021 and the estimated completion date of April 2022.[7] Phase III of the clinical trial was started on 16 March 2021 with the same number of participants.[14]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 LeBlanc, Zacharie; Waterhouse, Peter; Bally, Julia (2020-12-22). "Plant-based vaccines: The way ahead?". Viruses 13 (1): 5. doi:10.3390/v13010005. ISSN 1999-4915. PMID 33375155.
- ↑ "The hunt for a vaccine: Canadian company begins human testing of COVID-19 candidate". CTV News. 2020-07-14. https://www.ctvnews.ca/health/coronavirus/the-hunt-for-a-vaccine-canadian-company-begins-human-testing-of-covid-19-candidate-1.5022960.
- ↑ 3.0 3.1 "Canada's Medicago begins human trials of plant-based COVID-19 vaccine". National Post (Reuters). 2020-07-14. https://nationalpost.com/news/canada/canadas-medicago-begins-human-trials-of-plant-based-covid-19-vaccine.
- ↑ 4.0 4.1 Fischer, Rainer; Buyel, Johannes F. (2020). "Molecular farming – The slope of enlightenment (Review)". Biotechnology Advances 40: 107519. doi:10.1016/j.biotechadv.2020.107519. ISSN 0734-9750. PMID 31954848.
- ↑ 5.0 5.1 Dhama, Kuldeep; Natesan, Senthilkumar; Iqbal Yatoo, Mohd.; Patel, Shailesh Kumar; Tiwari, Ruchi; Saxena, Shailendra K; Harapan, Harapan (2020-12-01). "Plant-based vaccines and antibodies to combat COVID-19: current status and prospects (Review)". Human Vaccines and Immunotherapeutics 16 (12): 2913–2920. doi:10.1080/21645515.2020.1842034. ISSN 2164-5515. PMID 33270484.
- ↑ 6.0 6.1 "Plant bio-factories contributing to the COVID-19 fight". Drug Target Review. 15 April 2020. https://www.drugtargetreview.com/news/60116/plant-bio-factories-contributing-to-the-covid-19-fight/.
- ↑ 7.0 7.1 7.2 Clinical trial number NCT04636697 for "Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults" at ClinicalTrials.gov
- ↑ 8.0 8.1 "GSK partners with Medicago to develop plant-based Covid-19 vaccine". Pharmaceutical Technology. 8 July 2020. https://www.pharmaceutical-technology.com/news/gsk-medicago-covid-19-vaccine/.
- ↑ 9.0 9.1 "Medicago and GSK start of Phase II/III clinical trials of adjuvanted COVID-19 vaccine candidate". Drug Discovery World. 13 November 2020. https://www.ddw-online.com/medicago-and-gsk-start-of-phase-ii-iii-clinical-trials-of-adjuvanted-covid-19-vaccine-candidate-8329-202011/.
- ↑ "VLP technologies and production platform". Medicago. https://www.medicago.com/en/technologies/.
- ↑ Chung, Jee Young; Thone, Melissa N.; Kwon, Young Jik (2021). "COVID-19 vaccines: The status and perspectives in delivery points of view". Advanced Drug Delivery Reviews 170: 1–25. doi:10.1016/j.addr.2020.12.011. ISSN 0169-409X. PMID 33359141.
- ↑ "GSK signs deal with Medicago for COVID-19 vaccine". PMLive. 8 July 2020. https://www.pmlive.com/pharma_news/gsk_signs_deal_with_medicargo_for_covid-19_vaccine_1344532.
- ↑ Clinical trial number NCT04450004 for "Safety, Tolerability and Immunogenicity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years" at ClinicalTrials.gov
- ↑ "Medicago and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine candidate". GlaxoSmithKline. 16 March 2021. https://www.gsk.com/en-gb/media/press-releases/medicago-and-gsk-start-phase-3-trial-of-adjuvanted-covid-19-vaccine-candidate/.