TY - JOUR
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AU - Pacurar, Mihaela
AU - Palfreeman, Adrian
AU - Pan, Daniel
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AU - Saich, Stephen
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AU - Saralaya, Dinesh
AU - Sharma, Sunil
AU - Sheridan, Ray
AU - Sturdy, Ann
AU - Thomson, Emma C.
AU - Todd, Shirley
AU - Twelves, Chris
AU - Read, Robert C.
AU - Charlton, Sue
AU - Hallis, Bassam
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AU - Andrews, Nick
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AU - Snape, Matthew D.
AU - Liu, Xinxue
AU - Faust, Saul N.
AU - Riordan, Andrew
AU - Ustianowski, Andrew
AU - Rogers, Chris A
AU - Hughes, Stephen
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AU - Stockport, Jane
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AU - Grundy, Lynne
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AU - Coughlan, Tricia
AU - van Welsenes, Donald
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AU - Whittley, Sarah
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AU - Hamal, Shama
AU - Adams, Kirsty
AU - Baker, Holly
AU - Driver, Kimberley
AU - Turner, Nicola
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AU - Merida-Morillas, Marta
AU - Sakagami, Yukari
AU - Andrews, Antonette
AU - Goncalves-Cordeiro, Lillian
AU - Stokes, Matthew
AU - Ambihapathy, Wythehi
AU - Spencer, Joanne
AU - Parungao, Nina
AU - Berry, Lisa
AU - Cullinane, James
AU - Presland, Laura
AU - Ross-Russell, Amy
AU - Warren, Sarah
AU - Baker, Jonathan
AU - Oliver, Abigail
AU - Buadi, Amanda
AU - Lee, Kim
AU - Haskell, Louise
AU - Romani, Rossana
AU - Bentley, Ian
AU - Whitbred, Tim
AU - Fowler, Simon
AU - Gavin, John
AU - Magee, Alan
AU - Watson, Tara
AU - Nightingale, Kari
AU - Marius, Phedra
AU - Summerton, Eloise
AU - Locke, Emily
AU - Honey, Thomas
AU - Lingwood, Aidan
AU - de la Haye, Anastasia
AU - Elliott, Ryan Stephen
AU - Underwood, Karen
AU - King, Mikayala
AU - Davies-Dear, Sharon
AU - Horsfall, Emily
AU - Chalwin, Olivia
AU - Burton, Holly
AU - Edwards, Christopher J.
AU - Welham, Benjamin
AU - Garrahy, Sarah
AU - Hall, Fran
AU - Ladikou, Eleni
AU - Mullan, Dee
AU - Hansen, Daniel
AU - Campbell, Marion
AU - Dos Santos, Filipa
AU - Habash-Bailey, Haniah
AU - Lakeman, Nicki
AU - Branney, Debbie
AU - Vamplew, Luke
AU - Hogan, Alison
AU - Frankham, Jorden
AU - Wiselka, Martin
AU - Vail, Dennyl
AU - Wenn, Victoria
AU - Renals, Valerie
AU - Ellis, Kate
AU - Lewis-Taylor, Jessica
AU - Magan, Javier
AU - Hardy, Anna
AU - Appleby, Kim
PY - 2021
DA - December
TI - Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial
JO - Lancet
EP - 2276
VL - 398
IS - 10318
DO - http://dx.doi.org/10.1016/S0140-6736(21)02717-3
AB - Background: Few data exist on the comparative safety and immunogenicity of different COVID-19 vaccines given as a third (booster) dose. To generate data to optimise selection of booster vaccines, we investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines as a third dose after two doses of ChAdOx1 nCov-19 (Oxford–AstraZeneca; hereafter referred to as ChAd) or BNT162b2 (Pfizer–BioNtech, hearafter referred to as BNT). Methods: COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of third dose booster vaccination against COVID-19. Participants were aged older than 30 years, and were at least 70 days post two doses of ChAd or at least 84 days post two doses of BNT primary COVID-19 immunisation course, with no history of laboratory-confirmed SARS-CoV-2 infection. 18 sites were split into three groups (A, B, and C). Within each site group (A, B, or C), participants were randomly assigned to an experimental vaccine or control. Group A received NVX-CoV2373 (Novavax; hereafter referred to as NVX), a half dose of NVX, ChAd, or quadrivalent meningococcal conjugate vaccine (MenACWY) control (1:1:1:1). Group B received BNT, VLA2001 (Valneva; hereafter referred to as VLA), a half dose of VLA, Ad26.COV2.S (Janssen; hereafter referred to as Ad26) or MenACWY (1:1:1:1:1). Group C received mRNA1273 (Moderna; hereafter referred to as m1273), CVnCov (CureVac; hereafter referred to as CVn), a half dose of BNT, or MenACWY (1:1:1:1). Participants and all investigatory staff were blinded to treatment allocation. Coprimary outcomes were safety and reactogenicity and immunogenicity of anti-spike IgG measured by ELISA. The primary analysis for immunogenicity was on a modified intention-to-treat basis; safety and reactogenicity were assessed in the intention-to-treat population. Secondary outcomes included assessment of viral neutralisation and cellular responses. This trial is registered with ISRCTN, number 73765130. Findings: Between June 1 and June 30, 2021, 3498 people were screened. 2878 participants met eligibility criteria and received COVID-19 vaccine or control. The median ages of ChAd/ChAd-primed participants were 53 years (IQR 44–61) in the younger age group and 76 years (73–78) in the older age group. In the BNT/BNT-primed participants, the median ages were 51 years (41–59) in the younger age group and 78 years (75–82) in the older age group. In the ChAd/ChAD-primed group, 676 (46·7%) participants were female and 1380 (95·4%) were White, and in the BNT/BNT-primed group 770 (53·6%) participants were female and 1321 (91·9%) were White. Three vaccines showed overall increased reactogenicity: m1273 after ChAd/ChAd or BNT/BNT; and ChAd and Ad26 after BNT/BNT. For ChAd/ChAd-primed individuals, spike IgG geometric mean ratios (GMRs) between study vaccines and controls ranged from 1·8 (99% CI 1·5–2·3) in the half VLA group to 32·3 (24·8–42·0) in the m1273 group. GMRs for wild-type cellular responses compared with controls ranged from 1·1 (95% CI 0·7–1·6) for ChAd to 3·6 (2·4–5·5) for m1273. For BNT/BNT-primed individuals, spike IgG GMRs ranged from 1·3 (99% CI 1·0–1·5) in the half VLA group to 11·5 (9·4–14·1) in the m1273 group. GMRs for wild-type cellular responses compared with controls ranged from 1·0 (95% CI 0·7–1·6) for half VLA to 4·7 (3·1–7·1) for m1273. The results were similar between those aged 30–69 years and those aged 70 years and older. Fatigue and pain were the most common solicited local and systemic adverse events, experienced more in people aged 30–69 years than those aged 70 years or older. Serious adverse events were uncommon, similar in active vaccine and control groups. In total, there were 24 serious adverse events: five in the control group (two in control group A, three in control group B, and zero in control group C), two in Ad26, five in VLA, one in VLA-half, one in BNT, two in BNT-half, two in ChAd, one in CVn, two in NVX, two in NVX-half, and one in m1273. Interpretation: All study vaccines boosted antibody and neutralising responses after ChAd/ChAd initial course and all except one after BNT/BNT, with no safety concerns. Substantial differences in humoral and cellular responses, and vaccine availability will influence policy choices for booster vaccination. Funding: UK Vaccine Taskforce and National Institute for Health Research.
PB - Elsevier
UR - http://eprints.gla.ac.uk/259998/
KW - Coronavirus (COVID-19)
ER