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Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine.
Hager, Karen J; Pérez Marc, Gonzalo; Gobeil, Philipe; Diaz, Ricardo S; Heizer, Gretchen; Llapur, Conrado; Makarkov, Alexander I; Vasconcellos, Eduardo; Pillet, Stéphane; Riera, Fernando; Saxena, Pooja; Geller Wolff, Priscila; Bhutada, Kapil; Wallace, Garry; Aazami, Hessam; Jones, Christine E; Polack, Fernando P; Ferrara, Luciana; Atkins, Judith; Boulay, Iohann; Dhaliwall, Jiwanjeet; Charland, Nathalie; Couture, Manon M J; Jiang-Wright, Julia; Landry, Nathalie; Lapointe, Sophie; Lorin, Aurélien; Mahmood, Asif; Moulton, Lawrence H; Pahmer, Emmy; Parent, Julie; Séguin, Annie; Tran, Luan; Breuer, Thomas; Ceregido, Maria-Angeles; Koutsoukos, Marguerite; Roman, François; Namba, Junya; D'Aoust, Marc-André; Trepanier, Sonia; Kimura, Yosuke; Ward, Brian J.
  • Hager KJ; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Pérez Marc G; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Gobeil P; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Diaz RS; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Heizer G; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Llapur C; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Makarkov AI; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Vasconcellos E; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Pillet S; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Riera F; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Saxena P; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Geller Wolff P; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Bhutada K; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Wallace G; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Aazami H; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Jones CE; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Polack FP; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Ferrara L; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Atkins J; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Boulay I; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Dhaliwall J; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Charland N; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Couture MMJ; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Jiang-Wright J; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Landry N; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Lapointe S; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Lorin A; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Mahmood A; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Moulton LH; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Pahmer E; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Parent J; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Séguin A; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Tran L; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Breuer T; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Ceregido MA; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Koutsoukos M; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Roman F; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Namba J; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • D'Aoust MA; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Trepanier S; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Kimura Y; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
  • Ward BJ; From Medicago, Quebec, QC (K.J.H., P.G., G.H., A.I.M., S.P., P.S., K.B., J.A., I.B., J.D., N.C., M.M.J.C., J.J.-W., N.L., S.L., A.L., A.M., E.P., J.P., A.S., L.T., J.N., M.-A.D., S.T., Y.K., B.J.W.), Dawson Clinical Research, Guelph, ON (G.W.), and Research Institute of the McGill University Health
N Engl J Med ; 386(22): 2084-2096, 2022 06 02.
Article in English | MEDLINE | ID: covidwho-1830290
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 11 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.).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 / Adjuvants, Vaccine Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 / Adjuvants, Vaccine Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Language: English Journal: N Engl J Med Year: 2022 Document Type: Article