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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

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

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Medeiros-Ribeiro, Ana C. [1] ; Aikawa, Nadia E. [1, 2] ; Saad, Carla G. S. [1] ; Yuki, Emily F. N. [1] ; Pedrosa, Tatiana [1] ; Fusco, Solange R. G. [1] ; Rojo, Priscila T. [1] ; Pereira, Rosa M. R. [1] ; Shinjo, Samuel K. [1] ; Andrade, Danieli C. O. [1] ; Sampaio-Barros, Percival D. [1] ; Ribeiro, Carolina T. [1] ; Deveza, Giordano B. H. [1] ; Martins, Victor A. O. [1] ; Silva, Clovis A. [2] ; Lopes, Marta H. [3] ; Duarte, Alberto J. S. [4] ; Antonangelo, Leila [4] ; Sabino, Ester C. [5, 3] ; Kallas, Esper G. [3] ; Pasoto, Sandra G. [1] ; Bonfa, Eloisa [1]
Total Authors: 22
Affiliation:
[1] Univ Sao Paulo, Hosp Clin HCFMUSP, Rheumatol Div, Fac Med, Sao Paulo - Brazil
[2] Univ Sao Paulo, Inst Crianca, Hosp Clin HCFMUSP, Pediat Rheumatol Unit, Fac Med, Sao Paulo - Brazil
[3] Univ Sao Paulo, Hosp Clin HCFMUSP, Infect Dis Dept, Fac Med, Sao Paulo - Brazil
[4] Univ Sao Paulo, Hosp Clin HCFMUSP, Cent Lab Div, Fac Med, Sao Paulo - Brazil
[5] Univ Sao Paulo, Inst Med Trop, Fac Med, Sao Paulo - Brazil
Total Affiliations: 5
Document type: Journal article
Source: Nature Medicine; v. 27, n. 10 JUL 2021.
Web of Science Citations: 25
Abstract

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. (AU)

FAPESP's process: 18/09937-9 - Analysis of the immune profile of saliva and serum of patients with primary Sjogren's Syndrome
Grantee:Victor Adriano de Oliveira Martins
Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
FAPESP's process: 17/14352-7 - Assessment of relevance of blood levels of drugs in the monitoring rheumatic autoimmune diseases: safety, effectiveness and adherence to therapy
Grantee:Tatiana Do Nascimento Pedrosa
Support Opportunities: Scholarships in Brazil - Post-Doctoral
FAPESP's process: 19/21173-7 - Evaluation of the treatment of cutaneous lupus erythematosus with thalidomide: clinical, laboratory and histological factors associated with clinical response and adverse effects
Grantee:Carolina Torres Ribeiro
Support Opportunities: Scholarships in Brazil - Scientific Initiation
FAPESP's process: 15/03756-4 - Assessment of relevance of blood levels of drugs in the monitoring rheumatic autoimmune diseases: safety, effectiveness and adherence to therapy
Grantee:Eloisa Silva Dutra de Oliveira Bonfá
Support Opportunities: Research Projects - Thematic Grants
FAPESP's process: 20/11677-5 - Analysis of the immune profile of saliva and serum of patients with primary Sjögren's Syndrome
Grantee:Giordano Bruno Henriques Deveza
Support Opportunities: Scholarships in Brazil - Scientific Initiation