Benkeser David, Fong Youyi, Janes Holly E, Kelly Elizabeth J, Hirsch Ian, Sproule Stephanie, Stanley Ann Marie, Maaske Jill, Villafana Tonya, Houchens Christopher R, Martins Karen, Jayashankar Lakshmi, Castellino Flora, Ayala Victor, Petropoulos Christos J, Leith Andrew, Haugaard Deanne, Webb Bill, Lu Yiwen, Yu Chenchen, Borate Bhavesh, van der Laan Lars W P, Hejazi Nima S, Carpp Lindsay N, Randhawa April K, Andrasik Michele P, Kublin James G, Isaacs Margaret Brewinski, Makhene Mamodikoe, Tong Tina, Robb Merlin L, Corey Lawrence, Neuzil Kathleen M, Follmann Dean, Hoffman Corey, Falsey Ann R, Sobieszczyk Magdalena, Koup Richard A, Donis Ruben O, Gilbert Peter B
Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
NPJ Vaccines. 2023 Mar 11;8(1):36. doi: 10.1038/s41541-023-00630-0.
In the phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine conducted in the U.S., Chile, and Peru, anti-spike binding IgG concentration (spike IgG) and pseudovirus 50% neutralizing antibody titer (nAb ID50) measured four weeks after two doses were assessed as correlates of risk and protection against PCR-confirmed symptomatic SARS-CoV-2 infection (COVID-19). These analyses of SARS-CoV-2 negative participants were based on case-cohort sampling of vaccine recipients (33 COVID-19 cases by 4 months post dose two, 463 non-cases). The adjusted hazard ratio of COVID-19 was 0.32 (95% CI: 0.14, 0.76) per 10-fold increase in spike IgG concentration and 0.28 (0.10, 0.77) per 10-fold increase in nAb ID50 titer. At nAb ID50 below the limit of detection (< 2.612 IU50/ml), 10, 100, and 270 IU50/ml, vaccine efficacy was -5.8% (-651%, 75.6%), 64.9% (56.4%, 86.9%), 90.0% (55.8%, 97.6%) and 94.2% (69.4%, 99.1%). These findings provide further evidence towards defining an immune marker correlate of protection to help guide regulatory/approval decisions for COVID-19 vaccines.
在美国、智利和秘鲁进行的AZD1222（ChAdOx1 nCoV-19）疫苗3期试验中，在两剂疫苗接种四周后测量的抗刺突结合IgG浓度（刺突IgG）和假病毒50%中和抗体滴度（nAb ID50）被评估为针对PCR确诊的有症状SARS-CoV-2感染（COVID-19）的风险和保护相关性指标。这些对SARS-CoV-2阴性参与者的分析基于疫苗接种者的病例队列抽样（两剂接种后4个月内有33例COVID-19病例，463例非病例）。每10倍刺突IgG浓度增加，COVID-19的调整后风险比为0.32（95%CI：0.14，0.76）；每10倍nAb ID50滴度增加，调整后风险比为0.28（0.10，0.77）。在nAb ID50低于检测下限（<2.612 IU50/ml）、10、100和270 IU50/ml时，疫苗效力分别为-5.8%（-651%，75.6%）、64.9%（56.4%，86.9%）、90.0%（55.8%，97.6%）和94.2%（69.4%，99.1%）。这些发现为确定保护的免疫标志物相关性提供了进一步证据，以帮助指导COVID-19疫苗的监管/批准决策。
