Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine.
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine.
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DOI：
10.1056/nejmoa2107659
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发表时间：
2021-09-23
期刊：
影响因子：
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通讯作者：
2019nCoV-302 Study Group
中科院分区：
文献类型：
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作者：
Heath PT;Galiza EP;Baxter DN;Boffito M;Browne D;Burns F;Chadwick DR;Clark R;Cosgrove C;Galloway J;Goodman AL;Heer A;Higham A;Iyengar S;Jamal A;Jeanes C;Kalra PA;Kyriakidou C;McAuley DF;Meyrick A;Minassian AM;Minton J;Moore P;Munsoor I;Nicholls H;Osanlou O;Packham J;Pretswell CH;San Francisco Ramos A;Saralaya D;Sheridan RP;Smith R;Soiza RL;Swift PA;Thomson EC;Turner J;Viljoen ME;Albert G;Cho I;Dubovsky F;Glenn G;Rivers J;Robertson A;Smith K;Toback S;2019nCoV-302 Study Group
NVX-CoV2373疫苗(Novavax)是一种针对SARS-CoV-2(SARS-CoV-2)的重组纳米颗粒疫苗，它包含原型毒株的全长尖峰糖蛋白和Matrix-M佐剂，研究的早期临床数据表明，该疫苗是安全的，并与健康成年参与者的强大免疫反应有关。关于这种疫苗在更大人群中的有效性、免疫原性和安全性，还需要更多的数据。在第三阶段中，我们在英国的33个地点进行了随机、观察者盲法、安慰剂对照试验，我们以1：1的比例分配年龄在18岁到84岁之间的成年人接受两次肌肉注射5-μg剂量的NVX-CoV2373或安慰剂，相隔21天。主要疗效终点是病毒学确认的轻度、中度或重度SARS-CoV-2感染，在基线血清学阴性的参与者中，在第二次注射后至少7天发病。共有15,187名参与者接受了随机化，其中14,039人纳入了按方案进行的疗效人群。在参与者中，27.9%的人年龄在65岁或以上，44.6%的人有并存疾病。疫苗组的10名参与者和安慰剂组的96名参与者报告了感染，症状出现在第二次注射后至少7天，疫苗有效率为89.7%(95%可信区间[CI]，80.2至94.6)。疫苗组的10例病例中没有住院或死亡报告。报告了5例严重感染，均为安慰剂组。事后分析显示，对B.1.1.7(或α)变异体的有效率为86.3%(95%CI，71.3至93.5)，对非B.1.1.7变异体的有效率为96.4%(95%CI，73.8至99.5)。一般情况下，反应性是温和的和短暂的。两组严重不良事件发生率低且相似。成年参与者接种两剂NVX-CoV2373疫苗，对SARS-CoV-2感染的保护率为89.7%，对B.1.1.7变异株表现出高效率。(由Novavax提供资金；EudraCT编号，2020年-004123-16。)
Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population. In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline. A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups. A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16.)