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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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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]

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