Details

Autor(en) / Beteiligte

• Pereira, Rosa M.R.
• Dagostin, Marilia A.
• Caparbo, Valeria F.
• Sales, Lucas P.
• Pasoto, Sandra G.
• Silva, Clovis A.
• Yuki, Emily F.N.
• Saad, Carla G.S.
• Medeiros-Ribeiro, Ana C.
• Kupa, Leonard V.K.
• Fusco, Solange R.G.
• Martins, Victor A.O.
• Martins, Carolina C.M.F.
• Barbas, Carmen Valente
• Shinjo, Samuel K.
• Aikawa, Nadia E.
• Bonfa, Eloisa

Titel

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

Ist Teil von

• Clinics (São Paulo, Brazil), 2023-01, Vol.78, p.100150-100150, Article 100150

Ort / Verlag

United States: Elsevier España, S.L.U

Erscheinungsjahr

2023

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• •This study provides evidence that CoronaVac, an inactivated virus vaccine against SARS-CoV-2, is safe and has a moderate immunogenicity in AAV.•The authors identified that immunogenicity is negatively influenced by glucocorticoids.•A mild antibody decay occurs in 6-months with a good response with a booster dose, although lower than health controls. To evaluate inactivated CoronaVac prime vaccination, antibody decay, booster dose, and safety in ANCA-Associated Vasculitis (AAV) patients. 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). 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. 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).