Dataset Information

Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine.

ABSTRACT:

Background

Coronavirus-like particles (CoVLP) that are produced in plants and display the prefusion spike glycoprotein of the original strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are combined with an adjuvant (Adjuvant System 03 [AS03]) to form the candidate vaccine.

Methods

In this phase 3, multinational, randomized, placebo-controlled trial conducted at 85 centers, we assigned adults (≥18 years of age) in a 1:1 ratio to receive two intramuscular injections of the CoVLP+AS03 vaccine or placebo 21 days apart. The primary objective of the trial was to determine the efficacy of the CoVLP+AS03 vaccine in preventing symptomatic coronavirus disease 2019 (Covid-19) beginning at least 7 days after the second injection, with the analysis performed after the detection of at least 160 cases.

Results

A total of 24,141 volunteers participated in the trial; the median age of the participants was 29 years. Covid-19 was confirmed by polymerase-chain-reaction assay in 165 participants in the intention-to-treat population; all viral samples that could be sequenced contained variants of the original strain. Vaccine efficacy was 69.5% (95% confidence interval [CI], 56.7 to 78.8) against any symptomatic Covid-19 caused by five variants that were identified by sequencing. In a post hoc analysis, vaccine efficacy was 78.8% (95% CI, 55.8 to 90.8) against moderate-to-severe disease and 74.0% (95% CI, 62.1 to 82.5) among the participants who were seronegative at baseline. No severe cases of Covid-19 occurred in the vaccine group, in which the median viral load for breakthrough cases was lower than that in the placebo group by a factor of more than 100. Solicited adverse events were mostly mild or moderate and transient and were more frequent in the vaccine group than in the placebo group; local adverse events occurred in 92.3% and 45.5% of participants, respectively, and systemic adverse events in 87.3% and 65.0%. The incidence of unsolicited adverse events was similar in the two groups up to 21 days after each dose (22.7% and 20.4%) and from day 43 through day 201 (4.2% and 4.0%).

Conclusions

The CoVLP+AS03 vaccine was effective in preventing Covid-19 caused by a spectrum of variants, with efficacy ranging from 69.5% against symptomatic infection to 78.8% against moderate-to-severe disease. (Funded by Medicago; ClinicalTrials.gov number, NCT04636697.).

SUBMITTER: Hager KJ

PROVIDER: S-EPMC9127773 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine.

Hager Karen J KJ Pérez Marc Gonzalo G Gobeil Philipe P Diaz Ricardo S RS Heizer Gretchen G Llapur Conrado C Makarkov Alexander I AI Vasconcellos Eduardo E Pillet Stéphane S Riera Fernando F Saxena Pooja P Geller Wolff Priscila P Bhutada Kapil K Wallace Garry G Aazami Hessam H Jones Christine E CE Polack Fernando P FP Ferrara Luciana L Atkins Judith J Boulay Iohann I Dhaliwall Jiwanjeet J Charland Nathalie N Couture Manon M J MMJ Jiang-Wright Julia J Landry Nathalie N Lapointe Sophie S Lorin Aurélien A Mahmood Asif A Moulton Lawrence H LH Pahmer Emmy E Parent Julie J Séguin Annie A Tran Luan L Breuer Thomas T Ceregido Maria-Angeles MA Koutsoukos Marguerite M Roman François F Namba Junya J D'Aoust Marc-André MA Trepanier Sonia S Kimura Yosuke Y Ward Brian J BJ

The New England journal of medicine 20220504 22

<h4>Background</h4>Coronavirus-like particles (CoVLP) that are produced in plants and display the prefusion spike glycoprotein of the original strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are combined with an adjuvant (Adjuvant System 03 [AS03]) to form the candidate vaccine.<h4>Methods</h4>In this phase 3, multinational, randomized, placebo-controlled trial conducted at 85 centers, we assigned adults (≥18 years of age) in a 1:1 ratio to receive two intramuscular inject ...[more]

PMID: 35507508

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Dataset Information

Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine.

Background

Methods

Results

Conclusions

Publications

Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine.

Similar Datasets

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