Medicago, GSK Begin Phase 3 Trial Of Plant-derived COVID-19 Vaccine Candidate - Quick Facts


2021-03-16 21:30:14 RTTNews


Canadian biopharmaceutical company Medicago, Inc. and GlaxoSmithKline announced Tuesday the start of Phase 3 clinical testing of Medicago's plant-derived COVID-19 vaccine candidate in combination 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 enrollment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. 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 trial will enroll up to 30,000 volunteers worldwide and will take place in 10 countries pending regulatory approvals, starting with Canada and the United States, In parallel, Medicago has also initiated a feasibility study of a vaccine candidate to address the emerging COVID-19 variants. Medicago's plant-derived vaccine candidate against COVID-19 uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GSK's pandemic adjuvant. Two doses of 3.75 micrograms of CoVLP are administered 21 days apart. The plant-derived vaccine candidate, in combination with the pandemic adjuvant, was granted Fast Track designation by the US Food and Drug Administration (FDA) on February 17, 2021. For comments and feedback contact: Business News
加拿大生物制药公司Medicago,Inc.和葛兰素史克周二宣布,开始对Medicago的植物源COVID-19候选疫苗与GSK的大流行佐剂联合进行3期临床试验,这是正在进行的2/3期研究的一部分。 Medicago获得了加拿大和美国监管当局的批准,根据中期2阶段的阳性结果,将健康成年人纳入试验的第3阶段。 研究的第3阶段是一个事件驱动、随机、观察者盲法、安慰剂对照、双向交叉设计,将评估佐剂CoVLP制剂与安慰剂相比的疗效和安全性。 这项试验将在全球招募多达3万名志愿者,将在10个国家进行,等待监管机构的批准,首先是加拿大和美国, 同时,Medicago还启动了针对新出现的COVID-19变种的候选疫苗可行性研究。 Medicago针对COVID-19的候选植物源疫苗采用冠状病毒样颗粒(CoVLP)技术,该疫苗由表达为病毒样颗粒(VLPs)的重组spike(S)糖蛋白组成,并与GSK的大流行佐剂共同施用。每隔21天给药两次3.75微克的CoVLP。 该植物源疫苗候选物与大流行佐剂联合,于2021年2月17日获得美国食品和药物管理局(FDA)的快速通道指定。 如需评论和反馈,请联系 商业新闻