Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.
Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.
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DOI：
10.1101/2021.08.09.21261290
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发表时间：
2022-01-07
期刊：
影响因子：
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通讯作者：
Koup, Richard A
中科院分区：
文献类型：
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作者：
Gilbert, Peter B;Montefiori, David C;Koup, Richard A
背景：在冠状病毒效力(COVE)试验中，针对冠状病毒病-19(新冠肺炎)的mRNA1273疫苗估计效力为94%。方法：通过病例队列抽样，在第1天(第1剂)、第29天(第2剂)和第57天测定4种血清抗体标志物：抗SPEKE的免疫球蛋白结合抗体(BABS)、抗SPEKE受体结合域(RBD)的BABS和经世卫组织国际标准(CID50和CID80)校准的50%和80%抑制性假病毒中和抗体效价。没有SARS-CoV-2感染证据的参与者包括在内。结果：第57天的尖峰免疫球蛋白、RBD免疫球蛋白、CID50和CID80中和水平分别与新冠肺炎的风险呈负相关：危险比为0.66(95%可信区间0.50，0.88；p=0.005)；0.57(0.40，0.82；p=0.002)；0.42(0.27，0.65；p=0.002)。
BACKGROUND: In the Coronavirus Efficacy (COVE) trial, estimated mRNA-1273 vaccine efficacy against coronavirus disease-19 (COVID-19) was 94%. SARS-CoV-2 antibody measurements were assessed as correlates of COVID-19 risk and as correlates of protection.METHODS: Through case-cohort sampling, participants were selected for measurement of four serum antibody markers at Day 1 (first dose), Day 29 (second dose), and Day 57: IgG binding antibodies (bAbs) to Spike, bAbs to Spike receptor-binding domain (RBD), and 50% and 80% inhibitory dilution pseudovirus neutralizing antibody titers calibrated to the WHO International Standard (cID50 and cID80). Participants with no evidence of previous SARS-CoV-2 infection were included. Cox regression assessed in vaccine recipients the association of each Day 29 or 57 serologic marker with COVID-19 through 126 or 100 days of follow-up, respectively, adjusting for risk factors.RESULTS: Day 57 Spike IgG, RBD IgG, cID50, and cID80 neutralization levels were each inversely correlated with risk of COVID-19: hazard ratios 0.66 (95% CI 0.50, 0.88; p=0.005); 0.57 (0.40, 0.82; p=0.002); 0.42 (0.27, 0.65; p