Imperial College London
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ProfessorVictoriaCornelius

Faculty of Medicine, School of Public Health

Professor in Medical Statistics and Trials Methodology
 
 
 
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Contact

 

+44 (0)20 7594 1218v.cornelius

 
 
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Assistant

 

Mrs Ranjit Rayat +44 (0)20 7594 3445

 
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Location

 

111Stadium HouseWhite City Campus

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Summary

 

Publications

Citation

BibTex format

@article{Munro:2022:10.1016/S1473-3099(22)00271-7,
author = {Munro, APS and Feng, S and Janani, L and Cornelius, V and Aley, PK and Babbage, G and Baxter, D and Bula, M and Cathie, K and Chatterjee, K and Dodd, K and Enever, Y and Qureshi, E and Goodman, AL and Green, CA and Harndahl, L and Haughney, J and Hicks, A and van, der Klaauw AA and Kanji, N and Libri, V and Llewelyn, MJ and McGregor, AC and Maallah, M and Minassian, AM and Moore, P and Mughal, M and Mujadidi, YF and Holliday, K and Osanlou, O and Osanlou, R and Owens, DR and Pacurar, M and Palfreeman, A and Pan, D and Rampling, T and Regan, K and Saich, S and Bawa, T and Saralaya, D and Sharma, S and Sheridan, R and Thomson, EC and Todd, S and Twelves, C and Read, RC and Charlton, S and Hallis, B and Ramsay, M and Andrews, N and Lambe, T and Nguyen-Van-Tam, JS and Snape, MD and Liu, X and Faust, SN and COV-BOOST, study group},
doi = {10.1016/S1473-3099(22)00271-7},
journal = {Lancet Infectious Diseases},
pages = {1131--1141},
title = {Safety, immunogenicity, and reactogenicity of BNT162b2 and mRNA-1273 COVID-19 vaccines given as fourth-dose boosters following two doses of ChAdOx1 nCoV-19 or BNT162b2 and a third dose of BNT162b2 (COV-BOOST): a multicentre, blinded, phase 2, randomised trial},
url = {http://dx.doi.org/10.1016/S1473-3099(22)00271-7},
volume = {22},
year = {2022}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BACKGROUND: Some high-income countries have deployed fourth doses of COVID-19 vaccines, but the clinical need, effectiveness, timing, and dose of a fourth dose remain uncertain. We aimed to investigate the safety, reactogenicity, and immunogenicity of fourth-dose boosters against COVID-19. METHODS: The COV-BOOST trial is a multicentre, blinded, phase 2, randomised controlled trial of seven COVID-19 vaccines given as third-dose boosters at 18 sites in the UK. This sub-study enrolled participants who had received BNT162b2 (Pfizer-BioNTech) as their third dose in COV-BOOST and randomly assigned them (1:1) to receive a fourth dose of either BNT162b2 (30 μg in 0·30 mL; full dose) or mRNA-1273 (Moderna; 50 μg in 0·25 mL; half dose) via intramuscular injection into the upper arm. The computer-generated randomisation list was created by the study statisticians with random block sizes of two or four. Participants and all study staff not delivering the vaccines were masked to treatment allocation. The coprimary outcomes were safety and reactogenicity, and immunogenicity (anti-spike protein IgG titres by ELISA and cellular immune response by ELISpot). We compared immunogenicity at 28 days after the third dose versus 14 days after the fourth dose and at day 0 versus day 14 relative to the fourth dose. Safety and reactogenicity were assessed in the per-protocol population, which comprised all participants who received a fourth-dose booster regardless of their SARS-CoV-2 serostatus. Immunogenicity was primarily analysed in a modified intention-to-treat population comprising seronegative participants who had received a fourth-dose booster and had available endpoint data. This trial is registered with ISRCTN, 73765130, and is ongoing. FINDINGS: Between Jan 11 and Jan 25, 2022, 166 participants were screened, randomly assigned, and received either full-dose BNT162b2 (n=83) or half-dose mRNA-1273 (n=83) as a fourth dose. The median age of these participants was 70
AU  - Munro,APS
AU  - Feng,S
AU  - Janani,L
AU  - Cornelius,V
AU  - Aley,PK
AU  - Babbage,G
AU  - Baxter,D
AU  - Bula,M
AU  - Cathie,K
AU  - Chatterjee,K
AU  - Dodd,K
AU  - Enever,Y
AU  - Qureshi,E
AU  - Goodman,AL
AU  - Green,CA
AU  - Harndahl,L
AU  - Haughney,J
AU  - Hicks,A
AU  - van,der Klaauw AA
AU  - Kanji,N
AU  - Libri,V
AU  - Llewelyn,MJ
AU  - McGregor,AC
AU  - Maallah,M
AU  - Minassian,AM
AU  - Moore,P
AU  - Mughal,M
AU  - Mujadidi,YF
AU  - Holliday,K
AU  - Osanlou,O
AU  - Osanlou,R
AU  - Owens,DR
AU  - Pacurar,M
AU  - Palfreeman,A
AU  - Pan,D
AU  - Rampling,T
AU  - Regan,K
AU  - Saich,S
AU  - Bawa,T
AU  - Saralaya,D
AU  - Sharma,S
AU  - Sheridan,R
AU  - Thomson,EC
AU  - Todd,S
AU  - Twelves,C
AU  - Read,RC
AU  - Charlton,S
AU  - Hallis,B
AU  - Ramsay,M
AU  - Andrews,N
AU  - Lambe,T
AU  - Nguyen-Van-Tam,JS
AU  - Snape,MD
AU  - Liu,X
AU  - Faust,SN
AU  - COV-BOOST,study group
DO  - 10.1016/S1473-3099(22)00271-7
EP  - 1141
PY  - 2022///
SN  - 1473-3099
SP  - 1131
TI  - Safety, immunogenicity, and reactogenicity of BNT162b2 and mRNA-1273 COVID-19 vaccines given as fourth-dose boosters following two doses of ChAdOx1 nCoV-19 or BNT162b2 and a third dose of BNT162b2 (COV-BOOST): a multicentre, blinded, phase 2, randomised trial
T2  - Lancet Infectious Diseases
UR  - http://dx.doi.org/10.1016/S1473-3099(22)00271-7
UR  - https://www.ncbi.nlm.nih.gov/pubmed/35550261
UR  - https://www.sciencedirect.com/science/article/pii/S1473309922002717?via%3Dihub
UR  - http://hdl.handle.net/10044/1/98005
VL  - 22
ER  -
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