| 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, I.T.; Cosgrove, C.A.; Moore, P.; Bethune, C.; Nally, R.; Bula, M.; Kalra, P.A.; Clark, R.; Dargan, P.I.; Boffito, M.; Sheridan, R.; Moran, E.; Darton, T.C.; Burns, F.; Saralaya, D.; Duncan, C.J.A.; Lillie, P.J.; San Francisco Ramos, A.; Galiza, E.P.; Heath, P.T.; Girard, B.; Parker, C.; Rust, D.; Mehta, S.; de Windt, E.; Sutherland, A.; Tomassini, J.E.; Dutko, F.J.; Chalkias, S.; Deng, W.; Chen, X.; Feng, J.; Tracy, L.; Zhou, H.; Miller, J.M.; Das, R.; Browne, D.; Chadwick, D.; Emmett, S.; Galloway, J.; Jones, L.; Kaminski, R.; Lazarus, R.; Palfreeman, A.; Ramos, A.S.F.; Rampling, T.; Sahdev, A.; Soiza, R. |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2023 |
| Collection: |
White Rose Research Online (Universities of Leeds, Sheffield & York) |
| 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 |
| ISSN: |
1473-3099 |
| Relation: |
https://eprints.whiterose.ac.uk/id/eprint/201207/8/THELANCETID-D-23-00405_Lee_et_al_Omicron-BA.1_boosters_Text_CLEAN_Final_04-26-23_.pdf; Lee, I.T., Cosgrove, C.A., Moore, P. et al. (63 more authors) (2023) Omicron BA.1-containing mRNA-1273 boosters compared with the original COVID-19 vaccine in the UK: a randomised, observer-blind, active-controlled trial. The Lancet Infectious Diseases, 23 (9). pp. 1007-1019. ISSN: 1473-3099 |
| Availability: |
https://eprints.whiterose.ac.uk/id/eprint/201207/ |
| Rights: |
cc_by_nc_nd_4 |
| Accession Number: |
edsbas.87AAC6EA |
| Database: |
BASE |