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

Anti-SARS-CoV-2 inactivated vaccine in patients with ANCA-associated vasculitis: Immunogenicity, safety, antibody decay and the booster dose. (2022). Clinics, 78, 100150. https://doi.org/10.1016/j.clinsp.2022.100150