| Title: |
Omicron BA.1-containing mRNA-1273 boosters compared with the original COVID-19 vaccine in the UK: a randomised, observer-blind, active-controlled trial |
| Authors: |
Lee, Ivan T; Cosgrove, Catherine A; Moore, Patrick; Bethune, Claire; Nally, Rhiannon; Bula, Marcin; Kalra, Philip A; Clark, Rebecca; Dargan, Paul I; Boffito, Marta; Sheridan, Ray; Moran, Ed; Darton, Thomas C; Burns, Fiona; Saralaya, Dinesh; Duncan, Christopher JA; Lillie, Patrick J; San Francisco Ramos, Alberto; Galiza, Eva P; Heath, Paul T; Girard, Bethany; Parker, Christy; Rust, Dondi; Mehta, Shraddha; de Windt, Elizabeth; Sutherland, Andrea; Tomassini, Joanne E; Dutko, Frank J; Chalkias, Spyros; Deng, Weiping; Chen, Xing; Feng, Jing; Tracy, LaRee; Zhou, Honghong; Miller, Jacqueline M; Das, Rituparna; Study Investigators |
| Source: |
The Lancet Infectious Diseases , 23 (9) pp. 1007-1019. (2023) |
| Publisher Information: |
Elsevier |
| Publication Year: |
2023 |
| Collection: |
University College London: UCL Discovery |
| Subject Terms: |
Study Investigators |
| Description: |
BACKGROUND: The omicron BA.1 bivalent booster is used globally. Previous open-label studies of the omicron BA.1 (Moderna mRNA-1273.214) booster showed superior neutralising antibody responses against omicron BA.1 and other variants compared with the original mRNA-1273 booster. We aimed to compare the safety and immunogenicity of omicron BA.1 monovalent and bivalent boosters with the original mRNA-1273 vaccine in a large, randomised controlled trial. METHODS: In this large, randomised, observer-blind, active-controlled, phase 3 trial in the UK (28 hospital and vaccination clinic sites), individuals aged 16 years or older who had previously received two injections of any authorised or approved COVID-19 vaccine, with or without an mRNA vaccine booster (third dose), were randomly allocated (1:1) using interactive response technology to receive 50 μg omicron BA.1 monovalent or bivalent vaccines or 50 μg mRNA-1273 administered as boosters via deltoid intramuscular injection. The primary outcomes were safety and immunogenicity at day 29, including prespecified non-inferiority and superiority of booster immune responses, based on the neutralising antibody geometric mean concentration (GMC) ratios of the monovalent and bivalent boosters compared with mRNA-1273. Safety was assessed in all participants who received first or second boosters, and primary immunogenicity outcomes were assessed in all participants who received the planned booster dose, had pre-booster and day 29 antibody data, had no major protocol deviations, and who were SARS-CoV-2-negative. The study is registered with EudraCT (2022-000063-51) and ClinicalTrials.gov (NCT05249829) and is ongoing. FINDINGS: Between Feb 16 and March 24, 2022, 724 participants were randomly allocated to receive omicron BA.1 monovalent (n=366) or mRNA-1273 (n=357), and between April 2 and June 17, 2022, 2824 participants were randomly allocated to receive omicron BA.1 bivalent (n=1418) or mRNA-1273 (n=1395) vaccines as second boosters. Median durations (months) between the most ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/10173629/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/10173629/2/Chataway_CMI%20in%20PMS%20-%20accepted%20author%20version.pdf; https://discovery.ucl.ac.uk/id/eprint/10173629/ |
| Rights: |
open |
| Accession Number: |
edsbas.7A73B164 |
| Database: |
BASE |