| Title: |
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 |
| Authors: |
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; Lambe, T; 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 |
| Publisher Information: |
Elsevier |
| Publication Year: |
2025 |
| Collection: |
Oxford University Research Archive (ORA) |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1016/s0140-6736(21)02717-3 |
| Availability: |
https://doi.org/10.1016/s0140-6736(21)02717-3; https://ora.ox.ac.uk/objects/uuid:7e83fea4-a53e-4064-afab-03014b09fb22 |
| Rights: |
info:eu-repo/semantics/openAccess ; CC Attribution (CC BY) |
| Accession Number: |
edsbas.41348258 |
| Database: |
BASE |