From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).
N Engl J Med. 2022 Feb 10;386(6):531-543. doi: 10.1056/NEJMoa2116185. Epub 2021 Dec 15.
BACKGROUND: NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b-3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America. METHODS: We conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary objective was to determine vaccine efficacy against reverse-transcriptase-polymerase-chain-reaction-confirmed Covid-19 occurring at least 7 days after the second dose. Vaccine efficacy against moderate-to-severe disease and against different variants was also assessed. RESULTS: Of the 29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% ≥65 years of age) received at least one dose: 19,714 received vaccine and 9868 placebo. Over a period of 3 months, 77 cases of Covid-19 were noted - 14 among vaccine recipients and 63 among placebo recipients (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6; P<0.001). Ten moderate and 4 severe cases occurred, all in placebo recipients, yielding vaccine efficacy against moderate-to-severe disease of 100% (95% CI, 87.0 to 100). Most sequenced viral genomes (48 of 61, 79%) were variants of concern or interest - largely B.1.1.7 (alpha) (31 of the 35 genomes for variants of concern, 89%). Vaccine efficacy against any variant of concern or interest was 92.6% (95% CI, 83.6 to 96.7). Reactogenicity was mostly mild to moderate and transient but was more frequent among NVX-CoV2373 recipients than among placebo recipients and was more frequent after the second dose than after the first dose. CONCLUSIONS: NVX-CoV2373 was safe and effective for the prevention of Covid-19. Most breakthrough cases were caused by contemporary variant strains. (Funded by Novavax and others; PREVENT-19 ClinicalTrials.gov number, NCT04611802.).
背景：NVX-CoV2373 是一种佐剂增强的重组刺突蛋白纳米颗粒疫苗，在英国和南非的 2b-3 期临床试验中显示出对预防 2019 年冠状病毒病（COVID-19）的临床疗效，但尚未在北美进行疗效测试。
方法：我们在美国和墨西哥进行了一项 2021 年上半年的 3 期、随机、观察者设盲、安慰剂对照试验，以评估 NVX-CoV2373 在未感染过严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的成年人（≥18 岁）中的疗效和安全性。参与者按照 2:1 的比例随机分配接受两剂 NVX-CoV2373 或安慰剂，间隔 21 天。主要目的是确定第二剂后至少 7 天发生的逆转录酶-聚合酶链反应确认的 COVID-19 的疫苗有效性。还评估了疫苗对中度至重度疾病和不同变体的疗效。
结果：在 2020 年 12 月 27 日至 2021 年 2 月 18 日期间进行随机分组的 29949 名参与者中，共有 29582 名（中位数年龄为 47 岁；12.6%≥65 岁）接受了至少一剂：19714 名接受了疫苗，9868 名接受了安慰剂。在 3 个月的时间里，共出现了 77 例 COVID-19 病例-14 例在疫苗接种者中，63 例在安慰剂接种者中（疫苗有效性为 90.4%；95%置信区间[CI]，82.9 至 94.6；P<0.001）。有 10 例中度和 4 例严重病例，均发生在安慰剂组，这表明疫苗对中度至重度疾病的疗效为 100%（95%CI，87.0 至 100）。大多数测序的病毒基因组（61 个中的 48 个，79%）是关注或感兴趣的变体-主要是 B.1.1.7（alpha）（35 个关注变体中的 31 个，89%）。对任何关注或感兴趣的变体的疫苗有效性为 92.6%（95%CI，83.6 至 96.7）。不良反应主要为轻度至中度且短暂，但在 NVX-CoV2373 接种者中比安慰剂接种者更常见，且在第二剂后比第一剂后更常见。
结论：NVX-CoV2373 安全有效，可预防 COVID-19。大多数突破性病例是由当代变体株引起的。（由 Novavax 等资助；PREVENT-19 临床试验.gov 编号，NCT04611802。）
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