Imperial College London

DrVincenzoLibri

Faculty of MedicineNational Heart & Lung Institute

Honorary Clinical Lecturer
 
 
 
//

Contact

 

+44 (0)20 3313 1677v.libri

 
 
//

Location

 

NIHR Imperial Clinical Research FacilityICTEM buildingHammersmith Campus

//

Summary

 

Publications

Citation

BibTex format

@article{Voysey:2021:10.1016/S0140-6736(21)00432-3,
author = {Voysey, M and Clemens, SAC and Madhi, SA and Weckx, LY and Folegatti, PM and Aley, PK and Angus, B and Baillie, VL and Barnabas, SL and Bhorat, QE and Bibi, S and Briner, C and Cicconi, P and Clutterbuck, EA and Collins, AM and Cutland, CL and Darton, TC and Dheda, K and Dold, C and Duncan, CJA and Emary, KRW and Ewer, KJ and Flaxman, A and Fairlie, L and Faust, SN and Feng, S and Ferreira, DM and Finn, A and Galiza, E and Goodman, AL and Green, CM and Green, CA and Greenland, M and Hill, C and Hill, HC and Hirsch, I and Izu, A and Jenkin, D and Joe, CCD and Kerridge, S and Koen, A and Kwatra, G and Lazarus, R and Libri, V and Lillie, PJ and Marchevsky, NG and Marshall, RP and Mendes, AVA and Milan, EP and Minassian, AM and McGregor, A and Mujadidi, YF and Nana, A and Padayachee, SD and Phillips, DJ and Pittella, A and Plested, E and Pollock, KM and Ramasamy, MN and Ritchie, AJ and Robinson, H and Schwarzbold, AV and Smith, A and Song, R and Snape, MD and Sprinz, E and Sutherland, RK a},
doi = {10.1016/S0140-6736(21)00432-3},
journal = {The Lancet},
pages = {881--891},
title = {Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials},
url = {http://dx.doi.org/10.1016/S0140-6736(21)00432-3},
volume = {397},
year = {2021}
}

RIS format (EndNote, RefMan)

TY  - JOUR
AB - BackgroundThe ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered.MethodsWe present data from three single-blind randomised controlled trials—one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)—and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5×1010 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2×1010 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked
AU - Voysey,M
AU - Clemens,SAC
AU - Madhi,SA
AU - Weckx,LY
AU - Folegatti,PM
AU - Aley,PK
AU - Angus,B
AU - Baillie,VL
AU - Barnabas,SL
AU - Bhorat,QE
AU - Bibi,S
AU - Briner,C
AU - Cicconi,P
AU - Clutterbuck,EA
AU - Collins,AM
AU - Cutland,CL
AU - Darton,TC
AU - Dheda,K
AU - Dold,C
AU - Duncan,CJA
AU - Emary,KRW
AU - Ewer,KJ
AU - Flaxman,A
AU - Fairlie,L
AU - Faust,SN
AU - Feng,S
AU - Ferreira,DM
AU - Finn,A
AU - Galiza,E
AU - Goodman,AL
AU - Green,CM
AU - Green,CA
AU - Greenland,M
AU - Hill,C
AU - Hill,HC
AU - Hirsch,I
AU - Izu,A
AU - Jenkin,D
AU - Joe,CCD
AU - Kerridge,S
AU - Koen,A
AU - Kwatra,G
AU - Lazarus,R
AU - Libri,V
AU - Lillie,PJ
AU - Marchevsky,NG
AU - Marshall,RP
AU - Mendes,AVA
AU - Milan,EP
AU - Minassian,AM
AU - McGregor,A
AU - Mujadidi,YF
AU - Nana,A
AU - Padayachee,SD
AU - Phillips,DJ
AU - Pittella,A
AU - Plested,E
AU - Pollock,KM
AU - Ramasamy,MN
AU - Ritchie,AJ
AU - Robinson,H
AU - Schwarzbold,AV
AU - Smith,A
AU - Song,R
AU - Snape,MD
AU - Sprinz,E
AU - Sutherland,RK
AU - Thomson,EC
AU - Torok,ME
AU - Toshner,M
AU - Turner,DPJ
AU - Vekemans,J
AU - Villafana,TL
AU - White,T
AU - Williams,CJ
AU - Douglas,AD
AU - Hill,AVS
AU - Lambe,T
AU - Gilbert,SC
AU - Pollard,AJ
DO - 10.1016/S0140-6736(21)00432-3
EP - 891
PY - 2021///
SN - 0140-6736
SP - 881
TI - Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials
T2 - The Lancet
UR - http://dx.doi.org/10.1016/S0140-6736(21)00432-3
UR - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000626603400026&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR - https://www.sciencedirect.com/science/article/pii/S0140673621004323?via%3Dihub
UR - http://hdl.handle.net/10044/1/89707
VL - 397
ER -