Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.
J Infect Dis. 2022 Nov 11;226(10):1731-1742. doi: 10.1093/infdis/jiac188.
Messenger RNA (mRNA)-1273 vaccine demonstrated 93.2% efficacy against coronavirus disease 2019 (COVID-19) in the Coronavirus Efficacy (COVE) trial. The humoral immunogenicity results are now reported.
Participants received 2 mRNA-1273 (100 µg) or placebo injections, 28 days apart. Immune responses were evaluated in a prespecified, randomly selected per-protocol immunogenicity population (n = 272 placebo; n = 1185 mRNA-1273). Serum binding antibodies (bAbs) and neutralizing antibodies (nAbs) to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-spike protein were assessed at days 1, 29, and 57 by baseline SARS-CoV-2-negative (n = 1197) and SARS-CoV-2-positive (n = 260) status, age, and sex.
SARS-CoV-2-negative vaccinees had bAb geometric mean AU/mL levels of 35 753 at day 29 that increased to 316 448 at day 57 and nAb inhibitory dilution 50% titers of 55 at day 29 that rose to 1081 at day 57. In SARS-CoV-2-positive vacinees, the first mRNA-1273 injection elicited bAb and nAb levels that were 11-fold (410 049) and 27-fold (1479) higher than in SARS-CoV-2-negative vaccinees, respectively, and were comparable to levels after 2 injections in uninfected participants. Findings were generally consistent by age and sex.
mRNA-1273 elicited robust serologic immune responses across age, sex, and SARS-CoV-2 status, consistent with its high COVID-19 efficacy. Higher immune responses in those previously infected support a booster-type effect. Clinical Trials Registration. NCT04470427.
信使 RNA（mRNA）-1273 疫苗在冠状病毒病功效（COVE）试验中对 2019 年冠状病毒病（COVID-19）显示出 93.2%的功效。现将体液免疫原性结果报告如下。
参与者接受 2 剂 mRNA-1273（100μg）或安慰剂，间隔 28 天。在一个预先指定的、随机选择的符合方案免疫原性人群中评估免疫反应（n=272 安慰剂；n=1185 mRNA-1273）。通过基线 SARS-CoV-2 阴性（n=1197）和 SARS-CoV-2 阳性（n=260）状态、年龄和性别，在第 1、29 和 57 天评估血清结合抗体（bAb）和对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）-刺突蛋白的中和抗体（nAb）。
SARS-CoV-2 阴性疫苗接种者在第 29 天的 bAb 几何平均 AU/mL 水平为 35753，在第 57 天增加到 316448，在第 29 天的 nAb 抑制稀释 50%滴度为 55，在第 57 天增加到 1081。在 SARS-CoV-2 阳性疫苗接种者中，第一剂 mRNA-1273 疫苗引发的 bAb 和 nAb 水平分别比 SARS-CoV-2 阴性疫苗接种者高 11 倍（410049）和 27 倍（1479），与未感染者的两剂后水平相当。按年龄和性别分类，结果基本一致。
mRNA-1273 在年龄、性别和 SARS-CoV-2 状态下均能引起强烈的血清免疫反应，与其 COVID-19 高功效一致。在先前感染过的人群中更高的免疫反应支持增强型作用。临床试验注册。NCT04470427。
