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Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial.
Medeiros-Ribeiro, Ana C; Aikawa, Nadia E; Saad, Carla G S; Yuki, Emily F N; Pedrosa, Tatiana; Fusco, Solange R G; Rojo, Priscila T; Pereira, Rosa M R; Shinjo, Samuel K; Andrade, Danieli C O; Sampaio-Barros, Percival D; Ribeiro, Carolina T; Deveza, Giordano B H; Martins, Victor A O; Silva, Clovis A; Lopes, Marta H; Duarte, Alberto J S; Antonangelo, Leila; Sabino, Ester C; Kallas, Esper G; Pasoto, Sandra G; Bonfa, Eloisa.
  • Medeiros-Ribeiro AC; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Aikawa NE; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Saad CGS; Pediatric Rheumatology Unit, Instituto da Criança, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Yuki EFN; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Pedrosa T; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Fusco SRG; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Rojo PT; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Pereira RMR; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Shinjo SK; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Andrade DCO; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Sampaio-Barros PD; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Ribeiro CT; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Deveza GBH; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Martins VAO; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Silva CA; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Lopes MH; Pediatric Rheumatology Unit, Instituto da Criança, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Duarte AJS; Infectious Disease Department, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Antonangelo L; Central Laboratory Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Sabino EC; Central Laboratory Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Kallas EG; Infectious Disease Department, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Pasoto SG; Instituto de Medicina Tropical, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Bonfa E; Infectious Disease Department, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Nat Med ; 27(10): 1744-1751, 2021 10.
Article in English | MEDLINE | ID: covidwho-1526090
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Autoimmune Diseases / Rheumatic Diseases / COVID-19 Vaccines / COVID-19 / Antibodies, Viral Type of study: Controlled clinical trial / Observational study / Randomized controlled trials Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Nat Med Journal subject: Molecular Biology / Medicine Year: 2021 Document Type: Article Affiliation country: S41591-021-01469-5

Full text: Available Collection: International databases Database: MEDLINE Main subject: Autoimmune Diseases / Rheumatic Diseases / COVID-19 Vaccines / COVID-19 / Antibodies, Viral Type of study: Controlled clinical trial / Observational study / Randomized controlled trials Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Nat Med Journal subject: Molecular Biology / Medicine Year: 2021 Document Type: Article Affiliation country: S41591-021-01469-5