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@article{Stuart:2021:10.1016/S0140-6736(21)02718-5,
author = {Stuart, ASV and Shaw, RH and Liu, X and Greenland, M and Aley, PK and Andrews, NJ and Cameron, JC and Charlton, S and Clutterbuck, EA and Collins, AM and Darton, T and Dinesh, T and Duncan, CJA and England, A and Faust, SN and Ferreira, DM and Finn, A and Goodman, AL and Green, CA and Hallis, B and Heath, PT and Hill, H and Horsington, BM and Lambe, T and Lazarus, R and Libri, V and Lillie, PJ and Mujadidi, YF and Payne, R and Plested, EL and Provstgaard-Morys, S and Ramasamy, MN and Ramsay, M and Read, RC and Robinson, H and Screaton, GR and Singh, N and Turner, DPJ and Turner, PJ and Vichos, I and White, R and Nguyen-Van-Tam, JS and Snape, MD and Com-COV2, Study Group},
doi = {10.1016/S0140-6736(21)02718-5},
journal = {The Lancet},
pages = {36--49},
title = {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},
url = {http://dx.doi.org/10.1016/S0140-6736(21)02718-5},
volume = {399},
year = {2021}
}

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TY  - JOUR
AB  - 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&middo
AU  - Stuart,ASV
AU  - Shaw,RH
AU  - Liu,X
AU  - Greenland,M
AU  - Aley,PK
AU  - Andrews,NJ
AU  - Cameron,JC
AU  - Charlton,S
AU  - Clutterbuck,EA
AU  - Collins,AM
AU  - Darton,T
AU  - Dinesh,T
AU  - Duncan,CJA
AU  - England,A
AU  - Faust,SN
AU  - Ferreira,DM
AU  - Finn,A
AU  - Goodman,AL
AU  - Green,CA
AU  - Hallis,B
AU  - Heath,PT
AU  - Hill,H
AU  - Horsington,BM
AU  - Lambe,T
AU  - Lazarus,R
AU  - Libri,V
AU  - Lillie,PJ
AU  - Mujadidi,YF
AU  - Payne,R
AU  - Plested,EL
AU  - Provstgaard-Morys,S
AU  - Ramasamy,MN
AU  - Ramsay,M
AU  - Read,RC
AU  - Robinson,H
AU  - Screaton,GR
AU  - Singh,N
AU  - Turner,DPJ
AU  - Turner,PJ
AU  - Vichos,I
AU  - White,R
AU  - Nguyen-Van-Tam,JS
AU  - Snape,MD
AU  - Com-COV2,Study Group
DO  - 10.1016/S0140-6736(21)02718-5
EP  - 49
PY  - 2021///
SN  - 0140-6736
SP  - 36
TI  - 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
T2  - The Lancet
UR  - http://dx.doi.org/10.1016/S0140-6736(21)02718-5
UR  - https://www.ncbi.nlm.nih.gov/pubmed/34883053
UR  - http://hdl.handle.net/10044/1/93015
VL  - 399
ER  -

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