دورية أكاديمية
Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial
| العنوان: | Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial |
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| المؤلفون: | Stuart, ASV, Shaw, RH, Liu, X, Greenland, M, Aley, PK, Andrews, NJ, Cameron, JC, Charlton, S, Clutterbuck, EA, Collins, AM, Darton, T, Dinesh, T, Duncan, CJA, England, A, Faust, SN, Ferreira, DM, Finn, A, Goodman, AL, Green, CA, Hallis, B, Heath, PT, Hill, H, Horsington, BM, Lambe, T, Lazarus, R, Libri, V, Lillie, PJ, Mujadidi, YF, Payne, R, Plested, EL, Provstgaard-Morys, S, Ramasamy, MN, Ramsay, M, Read, RC, Robinson, H, Screaton, GR, Singh, N, Turner, DPJ, Turner, PJ, Vichos, I, White, R, Nguyen-Van-Tam, JS, Snape, MD |
| المساهمون: | Group, Com-COV2 Study |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2022 |
| المجموعة: | Oxford University Research Archive (ORA) |
| الوصف: | Background Given the importance of flexible use of different COVID-19 vaccines within the same schedule to facilitate rapid deployment, we studied mixed priming schedules incorporating an adenoviral-vectored vaccine (ChAdOx1 nCoV-19 [ChAd], AstraZeneca), two mRNA vaccines (BNT162b2 [BNT], Pfizer–BioNTech, and mRNA-1273 [m1273], Moderna) and a nanoparticle vaccine containing SARS-CoV-2 spike glycoprotein and Matrix-M adjuvant (NVX-CoV2373 [NVX], Novavax). Methods Com-COV2 is a single-blind, randomised, non-inferiority trial in which adults aged 50 years and older, previously immunised with a single dose of ChAd or BNT in the community, were randomly assigned (in random blocks of three and six) within these cohorts in a 1:1:1 ratio to receive a second dose intramuscularly (8–12 weeks after the first dose) with the homologous vaccine, m1273, or NVX. The primary endpoint was the geometric mean ratio (GMR) of serum SARS-CoV-2 anti-spike IgG concentrations measured by ELISA in heterologous versus homologous schedules at 28 days after the second dose, with a non-inferiority criterion of the GMR above 0·63 for the one-sided 98·75% CI. The primary analysis was on the per-protocol population, who were seronegative at baseline. Safety analyses were done for all participants who received a dose of study vaccine. The trial is registered with ISRCTN, number 27841311. Findings Between April 19 and May 14, 2021, 1072 participants were enrolled at a median of 9·4 weeks after receipt of a single dose of ChAd (n=540, 47% female) or BNT (n=532, 40% female). In ChAd-primed participants, geometric mean concentration (GMC) 28 days after a boost of SARS-CoV-2 anti-spike IgG in recipients of ChAd/m1273 (20 114 ELISA laboratory units [ELU]/mL [95% CI 18 160 to 22 279]) and ChAd/NVX (5597 ELU/mL [4756 to 6586]) was non-inferior to that of ChAd/ChAd recipients (1971 ELU/mL [1718 to 2262]) with a GMR of 10·2 (one-sided 98·75% CI 8·4 to ∞) for ChAd/m1273 and 2·8 (2·2 to ∞) for ChAd/NVX, compared with ChAd/ChAd. In BNT-primed participants, ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://ora.ox.ac.uk/objects/uuid:da01cb4e-98ba-4417-b888-9832a907d5feTest; https://doi.org/10.1016/s0140-6736Test(21)02718-5 |
| DOI: | 10.1016/s0140-6736(21)02718-5 |
| الإتاحة: | https://doi.org/10.1016/s0140-6736Test(21)02718-5 https://ora.ox.ac.uk/objects/uuid:da01cb4e-98ba-4417-b888-9832a907d5feTest |
| حقوق: | info:eu-repo/semantics/openAccess ; National Archives Open Government Licence (OGL) |
| رقم الانضمام: | edsbas.1B321BD3 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/s0140-6736(21)02718-5 |
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