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Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19.

作者信息

Ward Brian J, Gobeil Philipe, Séguin Annie, Atkins Judith, Boulay Iohann, Charbonneau Pierre-Yves, Couture Manon, D'Aoust Marc-André, Dhaliwall Jiwanjeet, Finkle Carolyn, Hager Karen, Mahmood Asif, Makarkov Alexander, Cheng Matthew P, Pillet Stéphane, Schimke Patricia, St-Martin Sylvie, Trépanier Sonia, Landry Nathalie

机构信息

Medicago Inc., Quebec City, Quebec, Canada.

Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.

出版信息

Nat Med. 2021 Jun;27(6):1071-1078. doi: 10.1038/s41591-021-01370-1. Epub 2021 May 18.


DOI:10.1038/s41591-021-01370-1
PMID:34007070
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8205852/
Abstract

Several severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are being deployed, but the global need greatly exceeds the supply, and different formulations might be required for specific populations. Here we report Day 42 interim safety and immunogenicity data from an observer-blinded, dose escalation, randomized controlled study of a virus-like particle vaccine candidate produced in plants that displays the SARS-CoV-2 spike glycoprotein (CoVLP: NCT04450004 ). The co-primary outcomes were the short-term tolerability/safety and immunogenicity of CoVLP formulations assessed by neutralizing antibody (NAb) and cellular responses. Secondary outcomes in this ongoing study include safety and immunogenicity assessments up to 12 months after vaccination. Adults (18-55 years, n = 180) were randomized at two sites in Quebec, Canada, to receive two intramuscular doses of CoVLP (3.75 μg, 7.5 μg, and 15 μg) 21 d apart, alone or adjuvanted with AS03 or CpG1018. All formulations were well tolerated, and adverse events after vaccination were generally mild to moderate, transient and highest in the adjuvanted groups. There was no CoVLP dose effect on serum NAbs, but titers increased significantly with both adjuvants. After the second dose, NAbs in the CoVLP + AS03 groups were more than tenfold higher than titers in Coronavirus 2019 convalescent sera. Both spike protein-specific interferon-γ and interleukin-4 cellular responses were also induced. This pre-specified interim analysis supports further evaluation of the CoVLP vaccine candidate.

摘要

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本文引用的文献

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Front Immunol. 2020-9-30

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