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

2021; Nature Portfolio; Volume: 27; Issue: 10 Linguagem: Inglês

10.1038/s41591-021-01469-5

1546-170X

Ana Cristina de Medeiros Ribeiro, Nádia Emi Aikawa, Carla Gonçalves Schahin Saad, Emily Figueiredo Neves Yuki, Tatiana do Nascimento Pedrosa, Solange Fusco, Priscila Tagliaferro Rojo, Rosa Maria Rodrigues Pereira, Samuel Katsuyuki Shinjo, Danieli Andrade, Percival D. Sampaio‐Barros, Carolina Torres Ribeiro, Giordano B. H. Deveza, Victor A. O. Martins, Clóvis A. Silva, Marta Heloísa Lopes, Alberto J. S. Duarte, Leila Antonângelo, Éster Cerdeira Sabino, Esper G. Kallás, Sandra Gofinet Pasoto, Eloísa Bonfá,

Immunodeficiency and Autoimmune Disorders

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.