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@article{Szubert:2023:10.1016/j.eclinm.2022.101823,
author = {Szubert, AJ and Pollock, KM and Cheeseman, HM and Alagaratnam, J and Bern, H and Bird, O and Boffito, M and Byrne, R and Cole, T and Cosgrove, CA and Faust, SN and Fidler, S and Galiza, E and Hassanin, H and Kalyan, M and Libri, V and McFarlane, LR and Milinkovic, A and O'Hara, J and Owen, DR and Owens, D and Pacurar, M and Rampling, T and Skene, S and Winston, A and Woolley, J and Yim, YTN and Dunn, DT and McCormack, S and Shattock, RJ and COVAC, 1 Study Team},
doi = {10.1016/j.eclinm.2022.101823},
journal = {EClinicalMedicine},
pages = {1--13},
title = {COVAC1 phase 2a expanded safety and immunogenicity study of a self-amplifying RNA vaccine against SARS-CoV-2.},
url = {http://dx.doi.org/10.1016/j.eclinm.2022.101823},
volume = {56},
year = {2023}
}

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TY  - JOUR
AB  - BACKGROUND: Lipid nanoparticle (LNP) encapsulated self-amplifying RNA (saRNA) is well tolerated and immunogenic in SARS-CoV-2 seronegative and seropositive individuals aged 18-75. METHODS: A phase 2a expanded safety and immunogenicity study of a saRNA SARS-CoV-2 vaccine candidate LNP-nCoVsaRNA, was conducted at participating centres in the UK between 10th August 2020 and 30th July 2021. Participants received 1 μg then 10 μg of LNP-nCoVsaRNA, ∼14 weeks apart. Solicited adverse events (AEs) were collected for one week post-each vaccine, and unsolicited AEs throughout. Binding and neutralisating anti-SARS-CoV-2 antibody raised in participant sera was measured by means of an anti-Spike (S) IgG ELISA, and SARS-CoV-2 pseudoneutralisation assay. (The trial is registered: ISRCTN17072692, EudraCT 2020-001646-20). FINDINGS: 216 healthy individuals (median age 51 years) received 1.0 μg followed by 10.0 μg of the vaccine. 28/216 participants were either known to have previous SARS-CoV2 infection and/or were positive for anti-Spike (S) IgG at baseline. Reactogenicity was as expected based on the reactions following licensed COVID-19 vaccines, and there were no serious AEs related to vaccination. 80% of baseline SARS-CoV-2 naïve individuals (147/183) seroconverted two weeks post second immunization, irrespective of age (18-75); 56% (102/183) had detectable neutralising antibodies. Almost all (28/31) SARS-CoV-2 positive individuals had increased S IgG binding antibodies following their first 1.0 μg dose with a ≥0.5log10 increase in 71% (22/31). INTERPRETATION: Encapsulated saRNA was well tolerated and immunogenic in adults aged 18-75 years. Seroconversion rates in antigen naïve were higher than those reported in our dose-ranging study. Further work is required to determine if this difference is related to a longer dosing interval (14 vs. 4 weeks) or dosing with 1.0 μg followed by 10.0 μg. Boosting of S IgG an
AU  - Szubert,AJ
AU  - Pollock,KM
AU  - Cheeseman,HM
AU  - Alagaratnam,J
AU  - Bern,H
AU  - Bird,O
AU  - Boffito,M
AU  - Byrne,R
AU  - Cole,T
AU  - Cosgrove,CA
AU  - Faust,SN
AU  - Fidler,S
AU  - Galiza,E
AU  - Hassanin,H
AU  - Kalyan,M
AU  - Libri,V
AU  - McFarlane,LR
AU  - Milinkovic,A
AU  - O'Hara,J
AU  - Owen,DR
AU  - Owens,D
AU  - Pacurar,M
AU  - Rampling,T
AU  - Skene,S
AU  - Winston,A
AU  - Woolley,J
AU  - Yim,YTN
AU  - Dunn,DT
AU  - McCormack,S
AU  - Shattock,RJ
AU  - COVAC,1 Study Team
DO  - 10.1016/j.eclinm.2022.101823
EP  - 13
PY  - 2023///
SN  - 2589-5370
SP  - 1
TI  - COVAC1 phase 2a expanded safety and immunogenicity study of a self-amplifying RNA vaccine against SARS-CoV-2.
T2  - EClinicalMedicine
UR  - http://dx.doi.org/10.1016/j.eclinm.2022.101823
UR  - https://www.ncbi.nlm.nih.gov/pubmed/36684396
UR  - https://www.sciencedirect.com/science/article/pii/S2589537022005521?via%3Dihub
UR  - http://hdl.handle.net/10044/1/102639
VL  - 56
ER  -

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