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Inactivated SARS-CoV-2 vaccine in primary Sjögren’s syndrome: humoral response, safety, and effects on disease activity

2022; Springer Science+Business Media; Volume: 41; Issue: 7 Linguagem: Inglês

10.1007/s10067-022-06134-x

ISSN

1434-9949

Autores

Sandra Gofinet Pasoto, Ari Stiel Radu Halpern, Lissiane Karine Noronha Guedes, Ana Cristina de Medeiros Ribeiro, Emily Figueiredo Neves Yuki, Carla Gonçalves Schahin Saad, Clóvis A. Silva, Léonard de Vinci Kanda Kupa, Lorena Elizabeth Betancourt Villamarín, Victor Adriano de Oliveira Martins, Carolina Campagnoli Machado Freire Martins, Giordano B. H. Deveza, Elaine Pires Leon, Cleonice Bueno, Tatiana do Nascimento Pedrosa, Roseli Eliana Beseggio Santos, Renata Soares, Nádia Emi Aikawa, Eloísa Bonfá,

Tópico(s)

Dermatological and COVID-19 studies

Resumo

There is no study specifically focused on SARS-CoV-2 vaccine in primary Sjögren's syndrome (pSS).To assess the immunogenicity, safety, possible effects on disease activity, and autoantibody profile of the Sinovac-CoronaVac vaccine in pSS.Fifty-one pSS patients and 102 sex- and age-balanced controls without autoimmune diseases were included in a prospective phase 4 trial of the Sinovac-CoronaVac vaccine (two doses 28 days apart, D0/D28). Participants were assessed in three face-to-face visits (D0/D28 and six weeks after the 2nd dose (D69)) regarding adverse effects; clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI); anti-SARS-CoV-2 S1/S2 IgG (seroconversion (SC) and geometric mean titers (GMT)); neutralizing antibodies (NAb); and pSS autoantibody profile.Patients and controls had comparable female sex frequency (98.0% vs. 98.0%, p = 1.000) and mean age (53.5 ± 11.7 vs. 53.4 ± 11.4 years, p = 0.924), respectively. On D69, pSS patients presented moderate SC (67.5% vs. 93.0%, p < 0.001) and GMT (22.5 (95% CI 14.6-34.5) vs. 59.6 (95% CI 51.1-69.4) AU/mL, p < 0.001) of anti-SARS-CoV-2 S1/S2 IgG but lower than controls, and also, moderate NAb frequency (52.5% vs. 73.3%, p = 0.021) but lower than controls. Median neutralizing activity on D69 was comparable in pSS (58.6% (IQR 43.7-63.6)) and controls (64% (IQR 46.4-81.1)) (p = 0.219). Adverse events were mild. clinESSDAI and anti-Ro(SS-A)/anti-La(SS-B) levels were stable throughout the study (p > 0.05).Sinovac-CoronaVac vaccine is safe in pSS, without a deleterious impact on disease activity, and has a moderate short-term humoral response, though lower than controls. Thus, a booster dose needs to be studied in these patients.ClinicalTrials.gov Identifier: NCT04754698. Key Points • Sinovac-CoronaVac vaccine is safe in pSS, without a detrimental effect on systemic disease activity, and has a moderate short-term humoral response • A booster dose should be considered in these patients.

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