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).

OBJECTIVES: To determine the possible association of serum 25-hydroxyvitamin D (25OHD) levels with disease activity and respiratory infection in granulomatosis with polyangiitis patients during two different periods: winter/spring and summer/autumn. METHODS: Thirty-two granulomatosis with polyangiitis patients were evaluated in the winter/spring, and the same patients (except 5) were evaluated in summer/autumn (n=27). The 25OHD levels were measured by radioimmunoassay. Disease activity was assessed by the Birmingham Vasculitis Activity Score Modified for Wegener’s Granulomatosis (BVAS/WG) and antineutrophil cytoplasmic antibody (ANCA) positivity. Respiratory infection was defined according the Centers for Disease Control and Prevention criteria. RESULTS: 25OHD levels were lower among patients in winter/spring than in summer/autumn (32.31±13.10 vs. 38.98±10.97 ng/mL, p=0.04). Seven patients met the criteria for respiratory infection: 5 in winter/spring and 2 in summer/autumn. Patients with respiratory infection presented lower 25OHD levels than those without infection (25.15±11.70 vs. 36.73±12.08 ng/mL, p=0.02). A higher frequency of low vitamin D levels (25OHD<20 ng/mL) was observed in patients with respiratory infection (37.5% vs. 7.8, p=0.04). Serum 25OHD levels were comparable between patients with (BVAS/WG≥1 plus positive ANCA) and without disease activity (BVAS/WG=0 plus negative ANCA) (35.40±11.48 vs. 35.34±13.13 ng/mL, p=0.98). CONCLUSIONS: Lower 25OHD levels were associated with respiratory infection but not disease activity in granulomatosis with polyangiitis patients. Our data suggest that hypovitaminosis D could be an important risk factor for respiratory infection in granulomatosis with polyangiitis patients.

OBJETIVOS: Avaliar longitudinalmente o conteúdo mineral ósseo (CMO), a densidade mineral óssea (DMO) e a massa magra do corpo inteiro obtidos através da densitometria óssea de dupla absorção de Raios-X (DXA) em recém-nascidos pré-termo (RNPT) e comparar com seus pares a termo (RNT) desde o nascimento até 6 meses de idade pós-natal corrigida. MÉTODOS: Foram estudados 28 recém-nascidos adequados para a idade gestacional: 14 recém-nascidos pré-termo e 14 recém-nascidos a termo. Utilizando-se a DXA, foram determinados CMO, DMO e massa magra em três momentos: 40 semanas de idade pós-concepcional corrigida, 3 e 6 meses de idade pós-natal corrigida. Os recém-nascidos pré-termo apresentavam ao nascimento uma idade gestacional igual ou inferior a 32 semanas e receberam leite da própria mãe ou leite humano de banco. RESULTADOS: Todos os recém-nascidos apresentaram um aumento nos valores de CMO, DMO e massa magra durante o estudo. Os recém-nascidos pré-termo apresentaram menor CMO, DMO e massa magra, com 40 semanas de idade pós-concepcional corrigida, em relação aos recém-nascidos a termo (p < 0,001, p < 0,001, e p = 0,047, respectivamente). Entretanto, houve uma aceleração no processo de mineralização nos pré-termos, suficiente para atingirem os valores normais do recém-nascidos a termo aos 6 meses de idade corrigida. CONCLUSÕES: Este estudo sugere que a densitometria óssea de dupla absorção de Raios-X constitui um bom método para a avaliação dos parâmetros de composição corporal no início e no seguimento destes recém-nascidos pré-termo.

OBJECTIVES: To longitudinally assess bone mineral content (BMC), bone mineral density (BMD), and whole-body lean mass obtained through bone densitometry by dual-energy X-ray absorptiometry (DXA) in preterm newborns (PTNs) and compare them with full-term newborns (FTNs) from birth to 6 months of corrected postnatal age. METHODS: A total of 28 adequate for gestational age (AGA) newborns were studied: 14 preterm and 14 full-term newborns. DXA was used to determine BMC, BMD, and lean mass in three moments: 40 weeks corrected post-conceptual age, as well as 3 and 6 months of corrected postnatal age. PTNs had gestational age ≤ 32 weeks at birth and were fed their mother's own milk or milk from the human milk bank. RESULTS: All infants had an increase in BMC, BMD, and lean body mass values during the study. PTNs had lower BMC, BMD, and lean mass at 40 weeks of corrected post-conceptual age in relation to FTNs (p < 0.001, p < 0.001, p = 0.047, respectively). However, there was an acceleration in the mineralization process of PTNs, which was sufficient to achieve the normal values of FTNs at 6 months of corrected age. CONCLUSIONS: This study suggests that bone densitometry by dual-energy X-ray absorptiometry is a good method for the assessment of body composition parameters at baseline, and at the follow-up of these PTNs.