Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine
Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine
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DOI：
10.1056/nejmoa2026920
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发表时间：
2020-12-10
影响因子：
158.5
通讯作者：
Glenn, Gregory M.
中科院分区：
文献类型：
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作者：
Keech, Cheryl;Albert, Gary;Glenn, Gregory M.
背景NVX-CoV2373是一种重组SARS-CoV-2纳米粒疫苗，由SARS-CoV-2全长S蛋白和Matrix-M1佐剂组成。方法我们启动了一项随机、安慰剂对照的1-2期试验，在131名健康成年人中评价rSARS-CoV-2疫苗(5和25µg剂量，加或不加Matrix-M1佐剂，观察者不知道试验组分配)的安全性和免疫原性。在第一阶段，疫苗接种包括两次肌肉注射，相隔21天。主要结果是反应性；根据食品和药物管理局的毒性评分，评估安全性的实验室数值(血清化学和血液学)；以及免疫球蛋白抗体(以酶联免疫吸附分析[ELISA]单位)。次要结果包括主动不良反应、野生型病毒中和试验(微量中和试验)和T细胞应答(细胞因子染色)。将免疫球蛋白G和微量中和试验结果与32份(免疫球蛋白G)和29份(中和)新冠肺炎恢复期血清标本进行比较。我们在第35天进行了初步分析。结果随机后，83名参与者被分配接受有佐剂的疫苗和25名没有佐剂的疫苗，23名参与者被分配接受安慰剂。未发现严重不良反应。在大多数参与者中，反应性缺失或轻微，更常见于佐剂，持续时间较短(平均，
BackgroundNVX-CoV2373 is a recombinant severe acute respiratory syndrome coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins and Matrix-M1 adjuvant.MethodsWe initiated a randomized, placebo-controlled, phase 1-2 trial to evaluate the safety and immunogenicity of the rSARS-CoV-2 vaccine (in 5-mu g and 25-mu g doses, with or without Matrix-M1 adjuvant, and with observers unaware of trial-group assignments) in 131 healthy adults. In phase 1, vaccination comprised two intramuscular injections, 21 days apart. The primary outcomes were reactogenicity; laboratory values (serum chemistry and hematology), according to Food and Drug Administration toxicity scoring, to assess safety; and IgG anti-spike protein response (in enzyme-linked immunosorbent assay [ELISA] units). Secondary outcomes included unsolicited adverse events, wild-type virus neutralization (microneutralization assay), and T-cell responses (cytokine staining). IgG and microneutralization assay results were compared with 32 (IgG) and 29 (neutralization) convalescent serum samples from patients with Covid-19, most of whom were symptomatic. We performed a primary analysis at day 35.ResultsAfter randomization, 83 participants were assigned to receive the vaccine with adjuvant and 25 without adjuvant, and 23 participants were assigned to receive placebo. No serious adverse events were noted. Reactogenicity was absent or mild in the majority of participants, more common with adjuvant, and of short duration (mean,