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
Elsevier, 2021
Online
academicJournal
Zugriff:
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 ...
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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
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Autor/in / Beteiligte Person: | Munro, APS ; Janani, L ; Cornelius, V ; Aley, PK ; Babbage, G ; Baxter, D ; Bula, M ; Cathie, K ; Chatterjee, K ; Dodd, K ; Enever, Y ; Gokani, K ; Goodman, AL ; Green, CA ; Harndahl, L ; Haughney, J ; Hicks, A ; Van der Klaauw, AA ; Kwok, J ; Libri, V ; Llewelyn, MJ ; McGregor, AC ; Minassian, AM ; Moore, P ; Mughal, M ; Mujadidi, YF ; Murira, J ; Osanlou, O ; Osanlou, R ; Owens, DR ; Pacurar, M ; Palfreeman, A ; Pan, D ; Rampling, T ; Regan, K ; Saich, S ; Salkeld, J ; Saralaya, D ; Sharma, S ; Sheridan, R ; Sturdy, A ; Thomson, EC ; Todd, S ; Twelves, C ; Read, RC ; Charlton, S ; Hallis, B ; Ramsay, M ; Andrews, N ; Nguyen-Van-Tam, JS ; Snape, MD ; Liu, X ; Faust, SN ; COV-BOOST study group |
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Veröffentlichung: | Elsevier, 2021 |
Medientyp: | academicJournal |
ISSN: | 0140-6736 (print) |
DOI: | 10.1016/S0140-6736(21)02717-3 |
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