Journal article

Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial

Keith J Chappell, Francesca L Mordant, Zheyi Li, Danushka K Wijesundara, Paula Ellenberg, Julia A Lackenby, Stacey TM Cheung, Naphak Modhiran, Michael S Avumegah, Christina L Henderson, Kym Hoger, Paul Griffin, Jillian Bennet, Luca Hensen, Wuji Zhang, Thi HO Nguyen, Sara Marrero-Hernandez, Kevin J Selva, Amy W Chung, Mai H Tran Show all

LANCET INFECTIOUS DISEASES | ELSEVIER SCI LTD | Published : 2021

Abstract

BACKGROUND: Given the scale of the ongoing COVID-19 pandemic, the development of vaccines based on different platforms is essential, particularly in light of emerging viral variants, the absence of information on vaccine-induced immune durability, and potential paediatric use. We aimed to assess the safety and immunogenicity of an MF59-adjuvanted subunit vaccine for COVID-19 based on recombinant SARS-CoV-2 spike glycoprotein stabilised in a pre-fusion conformation by a novel molecular clamp (spike glycoprotein-clamp [sclamp]). METHODS: We did a phase 1, double-blind, placebo-controlled, block-randomised trial of the sclamp subunit vaccine in a single clinical trial site in Brisbane, QLD, Aus..

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