<br>ENSEMBLE 单剂 Ad26.COV2.S 剂量疫苗功效临床试验的免疫相关性分析,Nature Microbiology

当前位置： X-MOL 学术 › Nat. Microbiol. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

ENSEMBLE 单剂 Ad26.COV2.S 剂量疫苗功效临床试验的免疫相关性分析
Nature Microbiology ( IF 20.5 ) Pub Date : 2022-11-10 , DOI: 10.1038/s41564-022-01262-1
Youyi Fong _{1,

2} , Adrian B McDermott ₃ , David Benkeser ₄ , Sanne Roels ₅ , Daniel J Stieh ₆ , An Vandebosch ₅ , Mathieu Le Gars ₆ , Griet A Van Roey ₆ , Christopher R Houchens ₇ , Karen Martins ₇ , Lakshmi Jayashankar ₇ , Flora Castellino ₇ , Obrimpong Amoa-Awua ₃ , Manjula Basappa ₃ , Britta Flach ₃ , Bob C Lin ₃ , Christopher Moore ₃ , Mursal Naisan ₃ , Muhammed Naqvi ₃ , Sandeep Narpala ₃ , Sarah O'Connell ₃ , Allen Mueller ₃ , Leo Serebryannyy ₃ , Mike Castro ₃ , Jennifer Wang ₃ , Christos J Petropoulos ₈ , Alex Luedtke ₉ , Ollivier Hyrien _{1,

2} , Yiwen Lu ₁ , Chenchen Yu ₁ , Bhavesh Borate ₁ , Lars W P van der Laan _{1,

9} , Nima S Hejazi _{1,

10} , Avi Kenny ₁₁ , Marco Carone ₁₁ , Daniel N Wolfe ₇ , Jerald Sadoff ₆ , Glenda E Gray _{12,

13} , Beatriz Grinsztejn ₁₄ , Paul A Goepfert ₁₅ , Susan J Little ₁₆ , Leonardo Paiva de Sousa ₁₄ , Rebone Maboa ₁₇ , April K Randhawa ₁ , Michele P Andrasik ₁ , Jenny Hendriks ₆ , Carla Truyers ₅ , Frank Struyf ₅ , Hanneke Schuitemaker ₆ , Macaya Douoguih ₆ , James G Kublin ₁ , Lawrence Corey _{1,

18} , Kathleen M Neuzil ₁₉ , Lindsay N Carpp ₁ , Dean Follmann ₂₀ , Peter B Gilbert _{1,

2,

11} , Richard A Koup ₃ , Ruben O Donis ₇ , , ,

Affiliation

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Janssen R&D, a division of Janssen Pharmaceutica NV, Beerse, Belgium.
Janssen Vaccines and Prevention, Leiden, the Netherlands.
Biomedical Advanced Research and Development Authority, Washington, DC, USA.
LabCorp-Monogram Biosciences, South San Francisco, CA, USA.
Department of Statistics, University of Washington, Seattle, WA, USA.
Division of Biostatistics, School of Public Health, Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Department of Biostatistics, University of Washington School of Public Health, Seattle, WA, USA.
Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
South African Medical Research Council, Cape Town, South Africa.
Evandro Chagas National Institute of Infectious Diseases-Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Division of Infectious Diseases, University of California San Diego, La Jolla, CA, USA.
Ndlovu Elandsdoorn Site, Dennilton, Limpopo, South Africa.
Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.
Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

在临床试验中测量疾病获得和保护的免疫相关性是改进疫苗设计的先决条件。我们分析了疫苗接种后 4 周的结合抗体和中和抗体测量值，作为 ENSEMBLE 的第 3 期双盲安慰剂对照阶段中度至重度危重症 COVID-19 风险的相关性，直至疫苗接种后 83 天。单剂量的 Ad26.COV2.S。我们还评估了试验队列中保护的相关性。在我们测量的三种抗体免疫标记中，我们发现大多数支持 50% 抑制稀释 (ID ₅₀ ) 中和抗体滴度作为风险和保护的相关性。 ID ₅₀每增加 10 倍，结果风险比为 0.49（95% 置信区间 0.29、0.81； P = 0.006）；在不可量化的 ID ₅₀ (<2.7 IU ₅₀ ml ⁻¹ ) 时，疫苗功效为 60% (43%, 72%)，在 ID ₅₀ = 96.3 IU ₅₀ ml −1 时，疫苗功效增加至 89% (78%, 96%) ^{- 1} . ENSEMBLE-US、mRNA-1273 疫苗的 COVE 试验和 AZD1222 疫苗的 COV002-UK 试验通过 ID ₅₀滴度曲线比较疫苗功效，支持 ID ₅₀滴度作为试验和疫苗类型之间保护的相关性。

"点击查看英文标题和摘要"

更新日期：2022-11-11

点击分享查看原文

点击收藏

公开下载

阅读更多本刊新发论文本刊介绍/投稿指南