Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial

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art_MEDEIROS-RIBEIRO_Immunogenicity_and_safety_of_the_CoronaVac_inactivated_vaccine_2021.PDF (3.62 MB)
Citações na Scopus
135
Tipo de produção
article
Data de publicação
2021
DOI
Scopus
Web of Science
PubMed
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ISSN da Revista
Título do Volume
Editora
NATURE PORTFOLIO
Autores
Citação
NATURE MEDICINE, v.27, n.10, p.1744-+, 2021
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
CoronaVac, an inactivated SARS-CoV-2 vaccine, has been approved for emergency use in several countries. However, its immunogenicity in immunocompromised individuals has not been well established. We initiated a prospective phase 4 controlled trial (no. NCT04754698, CoronavRheum) in 910 adults with autoimmune rheumatic diseases (ARD) and 182 age- and sex-frequency-matched healthy adults (control group, CG), who received two doses of CoronaVac. The primary outcomes were reduction of >= 15% in both anti-SARS-CoV-2 IgG seroconversion (SC) and neutralizing antibody (NAb) positivity 6 weeks (day 69 (D69)) after the second dose in the ARD group compared with that in the CG. Secondary outcomes were IgG SC and NAb positivity at D28, IgG titers and neutralizing activity at D28 and D69 and vaccine safety. Prespecified endpoints were met, with lower anti-SARS-Cov-2 IgG SC (70.4 versus 95.5%, P < 0.001) and NAb positivity (56.3 versus 79.3%, P < 0.001) at D69 in the ARD group than in the CG. Moreover, IgG titers (12.1 versus 29.7, P < 0.001) and median neutralization activity (58.7 versus 64.5%, P = 0.013) were also lower at D69 in patients with ARD. At D28, patients with ARD presented with lower IgG frequency (18.7 versus 34.6%, P < 0.001) and NAb positivity (20.6 versus 36.3%, P < 0.001) than that of the CG. There were no moderate/severe adverse events. These data support the use of CoronaVac in patients with ARD, suggesting reduced but acceptable short-term immunogenicity. The trial is still ongoing to evaluate the long-term effectiveness/immunogenicity. In a large prospective phase 4 trial, vaccination with CoronaVac, an inactivated SARS-CoV-2 vaccine, elicited significantly lower virus-specific IgG antibodies and neutralizing antibodies in patients with autoimmune rheumatic diseases than in age- and sex-matched healthy control trial participants.
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https://observatorio.fm.usp.br/handle/OPI/43737
Referências
  1. [Anonymous], 2007, GUID IND CLIN DAT NE
  2. [Anonymous], 2021, WHO DRAFT GUID ADV
  3. [Anonymous], 2021, DIZ TEXT BUL PROFF S
  4. [Anonymous], 2020, COR B COMPL
  5. [Anonymous], NOTICIAS CORONAVIRUS
  6. [Anonymous], WHO COR COVID 19 DAS
  7. AREND WP, 1990, ARTHRITIS RHEUM, V33, P1129
  8. Avanzato VA, 2020, CELL, V183, P1901, DOI 10.1016/j.cell.2020.10.049
  9. Baden LR, 2021, NEW ENGL J MED, V384, P403, DOI 10.1056/NEJMoa2035389
  10. Barrett JR, 2021, NAT MED, V27, P279, DOI 10.1038/s41591-020-01179-4
  11. Boyarsky B.J., ANN RHEUM DIS
  12. Boyarsky BJ, 2021, JAMA-J AM MED ASSOC, V325, P2204, DOI 10.1001/jama.2021.7489
  13. Boyarsky BJ, 2021, JAMA-J AM MED ASSOC, V325, P1784, DOI 10.1001/jama.2021.4385
  14. Bueno S.M., 2021, INTERIM REPORT SAFET, DOI [10.1101/2021.03.31.21254494, DOI 10.1101/2021.03.31.21254494]
  15. Buss LF, 2021, SCIENCE, V371, P288, DOI 10.1126/science.abe9728
  16. Choi B, 2020, NEW ENGL J MED, V383, P2291, DOI 10.1056/NEJMc2031364
  17. Committee for Medicinal Products for Human Use (CHMP), 2018, GUID RISK MAN SYST M
  18. Corman VM, 2020, EUROSURVEILLANCE, V25, P23, DOI 10.2807/1560-7917.ES.2020.25.3.2000045
  19. Coronavirus Brasil, PAIN COR
  20. Coutinho, MODEL BASED ESTIMATI, DOI [10.1101/2021.03.03.21252706v(2021), DOI 10.1101/2021.03.03.21252706V(2021)]
  21. de Souza WM, 2020, NAT HUM BEHAV, V4, P856, DOI 10.1038/s41562-020-0928-4
  22. Dejnirattisai W, 2021, CELL, V184, P2939, DOI 10.1016/j.cell.2021.03.055
  23. Faria NR, 2021, SCIENCE, V372, P815, DOI [10.1126/science.abh2644Article, 10.1126/science.abh2644, 10.1101/2021.02.26.21252554]
  24. Folegatti PM, 2020, LANCET, V396, P467, DOI 10.1016/S0140-6736(20)31604-4
  25. Funk T, 2021, EUROSURVEILLANCE, V26, DOI 10.2807/1560-7917.ES.2021.26.16.2100348
  26. Furer V, 2021, ANN RHEUM DIS, V80, P1330, DOI 10.1136/annrheumdis-2021-220647
  27. Geisen UM, 2021, ANN RHEUM DIS, V80, P1306, DOI 10.1136/annrheumdis-2021-220272
  28. Gianfrancesco M, 2021, ANN RHEUM DIS, V80, pE88, DOI 10.1136/annrheumdis-2020-218328
  29. Grainger R, 2021, BEST PRACT RES CL RH, V35, DOI 10.1016/j.berh.2020.101657
  30. Hallal PC, 2020, LANCET GLOB HEALTH, V8, pE1390, DOI 10.1016/S2214-109X(20)30387-9
  31. Harpaz R, 2016, JAMA-J AM MED ASSOC, V316, P2547, DOI 10.1001/jama.2016.16477
  32. Harris PA, 2009, J BIOMED INFORM, V42, P377, DOI 10.1016/j.jbi.2008.08.010
  33. Hunter PR, 2021, BMJ-BRIT MED J, V373, DOI 10.1136/bmj.n958
  34. KAPLAN JE, 1990, J ACQ IMMUN DEF SYND, V3, P1096
  35. LEAVITT RY, 1990, ARTHRITIS RHEUM, V33, P1101, DOI 10.1002/art.1780330807
  36. Lee JJ, 2014, ARTHRITIS RES THER, V16, DOI 10.1186/s13075-014-0435-y
  37. Lundberg IE, 2017, ANN RHEUM DIS, V76, P1955, DOI 10.1136/annrheumdis-2017-211468
  38. Mikuls TR, 2021, ARTHRITIS RHEUMATOL, V73, pE1, DOI 10.1002/art.41596
  39. Miyakis S, 2006, J THROMB HAEMOST, V4, P295, DOI 10.1111/j.1538-7836.2006.01753.x
  40. Mulligan MJ, 2020, NATURE, V586, P589, DOI 10.1038/s41586-020-2639-4
  41. Pablos JL, 2020, ANN RHEUM DIS, V79, P1544, DOI 10.1136/annrheumdis-2020-218296
  42. Palacios R, EFFICACY SAFETY COVI
  43. Petri M, 2012, ARTHRITIS RHEUM-US, V64, P2677, DOI 10.1002/art.34473
  44. Rambaut A, 2020, VIROLOGICAL
  45. Romano CM, REAL TIME PCR PROTOC
  46. Rubbert-Roth A, 2021, LANCET RHEUMATOL, V3, pE470, DOI 10.1016/S2665-9913(21)00186-7
  47. Rudwaleit M, 2009, ANN RHEUM DIS, V68, P777, DOI 10.1136/ard.2009.108233
  48. Saad CGS, 2011, ANN RHEUM DIS, V70, P1068, DOI 10.1136/ard.2011.150250
  49. Seyahi E, 2021, RHEUMATOL INT, V41, P1429, DOI 10.1007/s00296-021-04910-7
  50. Shoenfeld Y, 2011, J AUTOIMMUN, V36, P4, DOI 10.1016/j.jaut.2010.07.003
  51. Simon D, 2021, ANN RHEUM DIS, V80, P1312, DOI 10.1136/annrheumdis-2021-220461
  52. Spiera R, 2021, ANN RHEUM DIS, V80, P1357, DOI 10.1136/annrheumdis-2021-220604
  53. Strangfeld A, 2021, ANN RHEUM DIS, V80, P930, DOI 10.1136/annrheumdis-2020-219498
  54. Taylor SC, 2021, J CLIN MICROBIOL, V59, DOI 10.1128/JCM.02438-20
  55. Tillett W, 2012, J RHEUMATOL, V39, P154, DOI 10.3899/jrheum.110845
  56. van den Hoogen F, 2013, ANN RHEUM DIS, V72, P1747, DOI [10.1136/annrheumdis-2013-204424, 10.1002/art.38098]
  57. Vitali C, 2002, ANN RHEUM DIS, V61, P554, DOI 10.1136/ard.61.6.554
  58. Vogels CBF, 2021, PLOS BIOL, V19, DOI 10.1371/journal.pbio.3001236
  59. Zhang, EXPERT REV VACCINES, DOI [10.1080/14760584.2021(2021, DOI 10.1080/14760584.2021(2021]
  60. Zhang YJ, 2021, LANCET INFECT DIS, V21, P181, DOI 10.1016/S1473-3099(20)30843-4

Coleções
Artigos e Materiais de Revistas Científicas - FM/MCM
Artigos e Materiais de Revistas Científicas - COVID-19
Artigos e Materiais de Revistas Científicas - FM/MIP
Artigos e Materiais de Revistas Científicas - FM/MPE
Artigos e Materiais de Revistas Científicas - FM/MPT
Artigos e Materiais de Revistas Científicas - HC/ICHC
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