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Inactivated SARS-CoV-2 vaccine in primary Sjögren's syndrome: humoral response, safety, and effects on disease activity.
Pasoto, Sandra Gofinet; Halpern, Ari Stiel Radu; Guedes, Lissiane Karine Noronha; Ribeiro, Ana Cristina Medeiros; Yuki, Emily Neves Figueiredo; Saad, Carla Gonçalves Schahin; da Silva, Clovis Artur Almeida; de Vinci Kanda Kupa, Léonard; Villamarín, Lorena Elizabeth Betancourt; de Oliveira Martins, Victor Adriano; Martins, Carolina Campagnoli Machado Freire; Deveza, Giordano Bruno Henriques; Leon, Elaine Pires; Bueno, Cleonice; Pedrosa, Tatiana Nascimento; Santos, Roseli Eliana Beseggio; Soares, Renata; Aikawa, Nádia Emi; Bonfa, Eloisa.
  • Pasoto SG; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil. sandra.pasoto@hc.fm.usp.br.
  • Halpern ASR; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Guedes LKN; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Ribeiro ACM; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Yuki ENF; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Saad CGS; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • da Silva CAA; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • de Vinci Kanda Kupa L; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Villamarín LEB; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • de Oliveira Martins VA; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Martins CCMF; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Deveza GBH; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Leon EP; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Bueno C; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Pedrosa TN; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Santos REB; Central Laboratory Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
  • Soares R; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Aikawa NE; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
  • Bonfa E; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
Clin Rheumatol ; 41(7): 2079-2089, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1750715
ABSTRACT

INTRODUCTION:

There is no study specifically focused on SARS-CoV-2 vaccine in primary Sjögren's syndrome (pSS).

OBJECTIVES:

To assess the immunogenicity, safety, possible effects on disease activity, and autoantibody profile of the Sinovac-CoronaVac vaccine in pSS.

METHODS:

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.

RESULTS:

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).

CONCLUSION:

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. TRIAL REGISTRATION 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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Full text: Available Collection: International databases Database: MEDLINE Main subject: Sjogren&apos;s Syndrome / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Clin Rheumatol Year: 2022 Document Type: Article Affiliation country: S10067-022-06134-x

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Sjogren&apos;s Syndrome / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Clin Rheumatol Year: 2022 Document Type: Article Affiliation country: S10067-022-06134-x