作者
Nathalie Charland, Philipe Gobeil, Stéphane Pillet, Iohann Boulay, Annie Séguin, Alexander Makarkov, Gretchen Heizer, Kapil Bhutada, Asif Mahmood, Sonia Trépanier, Karen Hager, Julia Jiang-Wright, Judith Atkins, Pooja Saxena, Matthew P Cheng, Donald C Vinh, Philippe Boutet, François Roman, Robbert Van Der Most, Maria Angeles Ceregido, Marc Dionne, Guy Tellier, Jean-Sébastien Gauthier, Brandon Essink, Michael Libman, Jason Haffizulla, André Fréchette, Marc-André D’Aoust, Nathalie Landry, Brian J Ward
发表日期
2022/11/9
期刊
npj Vaccines
卷号
7
期号
1
页码范围
142
出版商
Nature Publishing Group UK
简介
The rapid spread of SARS-CoV-2 continues to impact humanity on a global scale with rising total morbidity and mortality. Despite the development of several effective vaccines, new products are needed to supply ongoing demand and to fight variants. We report herein a pre-specified interim analysis of the phase 2 portion of a Phase 2/3, randomized, placebo-controlled trial of a coronavirus virus-like particle (CoVLP) vaccine candidate, produced in plants that displays the SARS-CoV-2 spike glycoprotein, adjuvanted with AS03 (NCT04636697). A total of 753 participants were recruited between 25th November 2020 and 24th March 2021 into three groups: Healthy Adults (18–64 years: N = 306), Older Adults (≥65 years: N = 282) and Adults with Comorbidities (≥18 years: N = 165) and randomized 5:1 to receive two intramuscular doses of either vaccine (3.75 µg CoVLP/dose+AS03) or placebo, 21 days apart …
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N Charland, P Gobeil, S Pillet, I Boulay, A Séguin… - npj Vaccines, 2022