Journal article

Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose booster

TM Nolan, G Deliyannis, M Griffith, S Braat, LF Allen, J Audsley, AW Chung, M Ciula, NA Gherardin, ML Giles, TP Gordon, SL Grimley, L Horng, DC Jackson, JA Juno, K Kedzierska, SJ Kent, SR Lewin, M Littlejohn, HA McQuilten Show all

Ebiomedicine | ELSEVIER | Published : 2023

Abstract

Background: SARS-CoV-2 booster vaccination should ideally enhance protection against variants and minimise immune imprinting. This Phase I trial evaluated two vaccines targeting SARS-CoV-2 beta-variant receptor-binding domain (RBD): a recombinant dimeric RBD-human IgG1 Fc-fusion protein, and an mRNA encoding a membrane-anchored RBD. Methods: 76 healthy adults aged 18–64 y, previously triple vaccinated with licensed SARS-CoV-2 vaccines, were randomised to receive a 4th dose of either an adjuvanted (MF59®, CSL Seqirus) protein vaccine (5, 15 or 45 μg, N = 32), mRNA vaccine (10, 20, or 50 μg, N = 32), or placebo (saline, N = 12) at least 90 days after a 3rd boost vaccination or SARS-CoV-2 infec..

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