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

The Lancet - Tập 398 - Trang 2258-2276 - 2021
Alasdair P S Munro1,2, Leila Janani3, Victoria Cornelius3, Parvinder K Aley4,5, Gavin Babbage1, David Baxter6, Marcin Bula7, Katrina Cathie1,2, Krishna Chatterjee8, Kate Dodd7, Yvanne Enever9, Karishma Gokani10, Anna L Goodman11,12, Christopher A Green10, Linda Harndahl13, John Haughney14, Alexander Hicks13, Agatha A van der Klaauw15, Jonathan Kwok16, Teresa Lambe4,5
1NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK
2Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK
3Imperial Clinical Trials Unit, Imperial College London, London, UK
4Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
5NIHR Oxford Biomedical Research Centre, Oxford, UK
6Stockport NHS Foundation Trust, Stockport, UK
7NIHR Liverpool and Broadgreen Clinical Research Facility, Liverpool, UK
8NIHR Cambridge Clinical Research Facility, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
9PHARMExcel. Welwyn Garden City, Hertfordshire, UK
10NIHR/Wellcome Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
11Department of Infection, Guy's and St Thomas’ NHS Foundation Trust, London, UK
12MRC Clinical Trials Unit, University College London, London, UK
13Portsmouth Hospitals University NHS Trust, Portsmouth, UK
14Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde, Glasgow, UK
15Wellcome-MRC Institute of Metabolic Science, Department of Clinical Biochemistry, University of Cambridge, Cambridge, UK
16Cancer Research UK Oxford Centre, University of Oxford, Oxford, UK

Tài liệu tham khảo

Andrews, 2021, Vaccine effectiveness and duration of protection of Comirnaty, Vaxzevria and Spikevax against mild and severe COVID-19 in the UK, medRxiv Singanayagam, 2021, Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study, Lancet Infect Dis Pouwels, 2021, Effect of Delta variant on viral burden and vaccine effectiveness against new SARS-CoV-2 infections in the UK, Nat Med, 10.1038/s41591-021-01548-7 Tartof, 2021, Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study, Lancet, 398, 1407, 10.1016/S0140-6736(21)02183-8 Chemaitelly, 2021, Waning of BNT162b2 vaccine protection against SARS-CoV-2 infection in Qatar, N Engl J Med, 10.1056/NEJMoa2114114 Bar-On, 2021, Protection of BNT162b2 vaccine booster against COVID-19 in Israel, N Engl J Med, 385, 1393, 10.1056/NEJMoa2114255 Barda, 2021, Effectiveness of a third dose of the BNT162b2 mRNA COVID-19 vaccine for preventing severe outcomes in Israel: an observational study, Lancet, 10.1016/S0140-6736(21)02249-2 Liu, 2021, Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial, Lancet, 398, 856, 10.1016/S0140-6736(21)01694-9 Nordstrom, 2021, Effectiveness of heterologous ChAdOx1 nCoV-19 and mRNA prime-boost vaccination against symptomatic COVID-19 infection in Sweden: a nationwide cohort study, Lancet Reg Health Eur, 10.1016/j.lanepe.2021.100249 Shaw, 2021, Heterologous prime-boost COVID-19 vaccination: initial reactogenicity data, Lancet, 397, 2043, 10.1016/S0140-6736(21)01115-6 Polack, 2020, Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine, N Engl J Med, 383, 2603, 10.1056/NEJMoa2034577 Baden, 2021, Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine, N Engl J Med, 384, 403, 10.1056/NEJMoa2035389 Heath, 2021, Safety and efficacy of NVX-CoV2373 COVID-19 vaccine, N Engl J Med, 385, 1172, 10.1056/NEJMoa2107659 Hulme, 2021, Comparative effectiveness of ChAdOx1 versus BNT162b2 COVID-19 vaccines in health and social care workers in England: a cohort study using OpenSAFELY, medRxiv Deng, 2020, Primary exposure to SARS-CoV-2 protects against reinfection in rhesus macaques, Science, 369, 818, 10.1126/science.abc5343 Corbett, 2021, Immune correlates of protection by mRNA-1273 vaccine against SARS-CoV-2 in nonhuman primates, Science, 373, 10.1126/science.abj0299 Hall, 2021, SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN), Lancet, 397, 1459, 10.1016/S0140-6736(21)00675-9 Feng, 2021, Correlates of protection against symptomatic and asymptomatic SARS-CoV-2 infection, Nat Med, 27, 2032, 10.1038/s41591-021-01540-1 Tan, 2021, Early induction of functional SARS-CoV-2-specific T cells associates with rapid viral clearance and mild disease in COVID-19 patients, Cell Rep, 34, 10.1016/j.celrep.2021.108728 Tarke, 2021, Impact of SARS-CoV-2 variants on the total CD4+ and CD8+ T cell reactivity in infected or vaccinated individuals, Cell Rep Med, 2 Geers, 2021, SARS-CoV-2 variants of concern partially escape humoral but not T cell responses in COVID-19 convalescent donors and vaccine recipients, Sci Immunol, 6, 10.1126/sciimmunol.abj1750 Stuart ASV, Shaw RH, Liu X, et al. Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial. Lancet (in press). Atmar, 2021, Heterologous SARS-CoV-2 booster vaccinations—preliminary Report, medRxiv Li, 2021, Heterologous prime-boost immunization with CoronaVac and Convidecia, medRxiv Flaxman, 2021, Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002), Lancet, 398, 981, 10.1016/S0140-6736(21)01699-8 Falsey, 2021, SARS-CoV-2 neutralization with BNT162b2 vaccine dose 3, N Engl J Med, 385, 1627, 10.1056/NEJMc2113468 Choi, 2021, Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis, Nat Med, 27, 2025, 10.1038/s41591-021-01527-y Parry, 2021, Extended interval BNT162b2 vaccination enhances peak antibody generation in older people, medRxiv Sallusto, 2010, From vaccines to memory and back, Immunity, 33, 451, 10.1016/j.immuni.2010.10.008