Anti-SARS-CoV-2 inactivated vaccine in patients with ANCA-associated vasculitis: Immunogenicity, safety, antibody decay and the booster dose

Authors

  • Rosa M.R. Pereira Universidade de São Paulo
  • Marilia A. Dagostin Universidade de São Paulo https://orcid.org/0000-0002-3203-768X
  • Valeria F. Caparbo Universidade de São Paulo
  • Lucas P. Sales Universidade de São Paulo https://orcid.org/0000-0003-2439-2240
  • Sandra G. Pasoto Universidade de São Paulo
  • Clovis A. Silva Universidade de São Paulo
  • Emily F.N. Yuki Universidade de São Paulo https://orcid.org/0000-0001-8801-405X
  • Carla G.S. Saad Universidade de São Paulo
  • Ana C. Medeiros-Ribeiro Universidade de São Paulo
  • Leonard V.K. Kupa Universidade de São Paulo
  • Solange R.G. Fusco Universidade de São Paulo
  • Victor A.O. Martins Universidade de São Paulo https://orcid.org/0000-0002-5926-3388
  • Carolina C.M.F. Martins Universidade de São Paulo
  • Carmen Valente Barbas Universidade de São Paulo
  • Samuel K. Shinjo Universidade de São Paulo
  • Nadia E. Aikawa Universidade de São Paulo
  • Eloisa Bonfa Universidade de São Paulo

DOI:

https://doi.org/10.1016/j.clinsp.2022.100150

Keywords:

ANCA-associated vasculitis, Vaccine, SARS-CoV-2, Immunogenicity

Abstract

Objective: To evaluate inactivated CoronaVac prime vaccination, antibody decay, booster dose, and safety in ANCA-Associated Vasculitis (AAV) patients.

Methods: Fifty-three AAV patients and 106 Controls (CG) received CoronaVac on days: D0 (first dose), D28(second dose), and D210 (booster dose, 32 AAV: 32 CG). The primary outcome was immunogenicity after the second vaccine dose (day 69) assessed by Seroconversion Rates (SC) of anti-SARS-CoV-2 S1/S2 IgG and Neutralizing Antibodies (NAb). Secondary outcomes were safety, immunogenicity (D28/D240), 6-months antibody decay (D210) and the booster dose response (D240).

Results: At D69 SC (65.1% vs. 96.8%, p = 0.0001), GMT (21.3 UA/mL vs. 67.7 UA/mL, p < 0.001) and NAb- positivity (53.7% vs. 80.6%, p = 0.001) were moderate but lower in naïve-AAV patients than CG. Patients without SC used more often IS (93.3% vs. 53.3%, p = 0.015), mycophenolate mofetil (20% vs. 0%, p = 0.037) and prednisone (60.0% vs. 28.6%, p = 0.057) than seroconverted. NAb negativity in AAV patients was associated with prednisone treatment (57.9% vs. 18.2%, p = 0.015) and IS (84.2% vs. 55.0%, p = 0.046). Logistic regression analysis models showed that only prednisone was associated with lower seroconversion (OR = 0.2, 0,95% CI 0.05‒0.86, p = 0.030) and with lower NAb positivity (OR = 0.2, 0,95% CI 0.05‒0.88, p = 0.034). After six months (D69‒D210) a decrease in IgG positivity occurred in 32 AAV patients (15.7%, p = 0.074) and 32 CG (18.7%, p = 0.041). For the NAb positivity, the 6-month decrease was not significant (p = 0.114) whereas a major reduction occurred for CG (p < 0.001). A booster dose (D240) resulted in an increment in IgG-positivity (21.9%, p = 0.023) and NAb-positivity (34.4%, p = 0.006) in AAV patients. No moderate/severe adverse events attributable to the vaccine were observed.

Conclusion: This study provides novel data on the excellent safety and moderate immunogenicity of CoronaVac in AAV patients. A six-month mild antibody waning was observed with a good response to the booster dose, although levels remained lower than CG (CoronavRheum-NCT04754698).

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Published

2022-11-29

Issue

Vol. 78 (2023)

Section

Original Articles

How to Cite

Pereira, R. M., Dagostin, M. A., Caparbo, V. F., Sales, L. P., Pasoto, S. G., Silva, C. A., Yuki, E. F., Saad, C. G., Medeiros-Ribeiro, A. C., Kupa, L. V., Fusco, S. R., Martins, V. A., Martins, C. C., Barbas, C. V., Shinjo, S. K., Aikawa, N. E., & Bonfa, E. (2022). Anti-SARS-CoV-2 inactivated vaccine in patients with ANCA-associated vasculitis: Immunogenicity, safety, antibody decay and the booster dose. Clinics, 78, 100150. https://doi.org/10.1016/j.clinsp.2022.100150