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Artigo Acesso aberto Produção Nacional Revisado por pares
BIBTEX RIS

Systemic autoimmune myopathies: a prospective phase 4 controlled trial of an inactivated virus vaccine against SARS-CoV-2

2021; Oxford University Press; Volume: 61; Issue: 8 Linguagem: Inglês

10.1093/rheumatology/keab773

ISSN

1462-0332

Autores

Samuel Katsuyuki Shinjo, Fernando Henrique Carlos de Souza, Isabela Bruna Pires Borges, Alexandre Moura dos Santos, Renata Miossi, Rafael Giovani Missé, Ana Cristina de Medeiros Ribeiro, Carla Gonçalves Schahin Saad, Emily Figueiredo Neves Yuki, Sandra Gofinet Pasoto, Léonard de Vinci Kanda Kupa, Carina Ceneviva, Júlia Celestino Seraphim, Tatiana do Nascimento Pedrosa, Margarete B. G. Vendramini, Clóvis A. Silva, Nádia Emi Aikawa, Eloísa Bonfá,

Tópico(s)

SARS-CoV-2 and COVID-19 Research

Resumo

To evaluate immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in systemic autoimmune myopathies (SAMs) and the possible influence of baseline disease parameters, comorbidities and therapy on immune response.This prospective controlled study included 53 patients with SAMs and 106 non-immunocompromised control group (CTRL). All participants received two doses of the Sinovac-CoronaVac vaccine (28-day interval). Immunogenicity was assessed by anti-SARS-CoV-2 S1/S2 IgG seroconversion (SC), anti-S1/S2 IgG geometric mean titre (GMT), factor increase GMT (FI-GMT), neutralizing antibodies (NAb) positivity, and median neutralizing activity after each vaccine dose (D0 and D28) and six weeks after the second dose (D69). Participants with pre-vaccination positive IgG serology and/or NAb and those with RT-PCR confirmed COVID-19 during the protocol were excluded from immunogenicity analysis.Patients and CTRL had comparable sex (P>0.99) and age (P=0.90). Immunogenicity of 37 patients and 79 CTRL-naïve participants revealed at D69, a moderate but significantly lower SC (64.9% vs 91.1%, P<0.001), GMT [7.9 (95%CI 4.7-13.2) vs 24.7 (95%CI 30.0-30.5) UA/ml, P<0.001] and frequency of NAb (51.4% vs 77.2%, P 0.05).Sinovac-CoronaVac is safe and has a moderate short-term immunogenicity in SAMs, but reduced compared with CTRL. We further identified that immunosuppression is associated with diminished NAb positivity.COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS (CoronavRheum), http://clinicaltrials.gov/ct2/show/NCT04754698.

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