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). Objective vaccination ANCAAssociated ANCA Associated (AAV Methods Fiftythree Fifty three 10 (CG days D first , dose) D28second Dsecond D28 D21 3 . CG) day 69 (SC antiSARSCoV2 antiSARSCoV anti SARS CoV 2 anti-SARS-CoV- S1S2 SS S1 S2 S S1/S NAb. (NAb) D28/D240, D28D240 DD D28/D240 D240 (D28/D240) 6months 6 (D210 D240. Results D6 65.1% 651 65 1 (65.1 vs 968 96 8 96.8% 0.0001, 00001 0.0001 0 0001 0.0001) 21.3 213 21 (21. UAmL UA mL 677 67 7 67. 0.001 001 53.7% 537 53 (53.7 806 80 80.6% naïveAAV naïve 93.3% 933 93 (93.3 533 53.3% 0.015, 0015 0.015 015 20% 20 (20 0% 0.037 0037 037 60.0% 600 60 (60.0 286 28 28.6% 0.057 0057 057 seroconverted 57.9% 579 57 9 (57.9 182 18 18.2% 84.2% 842 84 (84.2 550 55 55.0% 0.046. 0046 0.046 046 0.046) OR 02 0.2 095 95 0,95 005086 05 86 0.05–0.86 0.030 0030 030 005088 88 0.05–0.88 0.034. 0034 0.034 034 0.034) D69–D210 D69D210 (D69–D210 15.7%, 157 15 (15.7% 0.074 0074 074 18.7%, 187 (18.7% 0.041. 0041 0.041 041 0.041) 6month month 0.114 0114 114 0.001. (D240 IgGpositivity 21.9%, 219 (21.9% 0.023 0023 023 NAbpositivity 34.4%, 344 34 4 (34.4% 0.006 0006 006 moderatesevere severe Conclusion sixmonth CoronavRheumNCT04754698. CoronavRheumNCT04754698 CoronavRheumNCT CoronavRheum NCT04754698 NCT (CoronavRheum-NCT04754698) D2 anti-SARS-CoV S1S (NAb D28D24 D28/D24 D24 (D28/D240 (D21 65.1 (65. 96.8 0000 0.000 000 21. (21 0.00 00 53.7 5 (53. 80.6 93.3 (93. 53.3 0.01 01 (2 0.03 003 03 60.0 (60. 28.6 0.05 005 57.9 (57. 18.2 84.2 (84. 55.0 004 0.04 04 0. 09 0,9 00508 0.05–0.8 D69–D21 D69D21 (D69–D21 15.7% (15.7 0.07 007 07 18.7% (18.7 0.11 011 11 (D24 21.9% (21.9 0.02 002 34.4% (34.4 CoronavRheumNCT0475469 NCT0475469 (CoronavRheum-NCT04754698 D28D2 D28/D2 (D28/D24 (D2 65. (65 96. 0.0 53. (53 80. 93. (93 ( 60. (60 28. 57. (57 18. 84. (84 55. 0, 0050 0.05–0. D69–D2 D69D2 (D69–D2 15.7 (15. 18.7 (18. 0.1 21.9 34.4 (34. CoronavRheumNCT047546 NCT047546 (CoronavRheum-NCT0475469 D28D D28/D (D28/D2 (D (6 (5 (9 (8 0.05–0 D69–D D69D (D69–D 15. (15 (18 34. (34 CoronavRheumNCT04754 NCT04754 (CoronavRheum-NCT047546 (D28/D 0.05– (1 (3 CoronavRheumNCT0475 NCT0475 (CoronavRheum-NCT04754 CoronavRheumNCT047 NCT047 (CoronavRheum-NCT0475 CoronavRheumNCT04 NCT04 (CoronavRheum-NCT047 CoronavRheumNCT0 NCT0 (CoronavRheum-NCT04 (CoronavRheum-NCT0 (CoronavRheum-NCT

INTRODUÇÃO: A granulomatose de Wegener (GW) é uma forma de vasculite sistêmica que envolve primariamente as vias aéreas superiores e inferiores e os rins. As manifestações mais frequentes nas vias aéreas são estenose subglótica e inflamações, estenoses da traqueia e dos brônquios. A visualização endoscópica das vias aéreas é a melhor ferramenta para avaliação, diagnóstico e manejo dessas alterações. OBJETIVOS: Descrever as alterações endoscópicas encontradas na mucosa das vias aéreas de um grupo de pacientes com GW submetido à broncoscopia no Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP) e relatar as intervenções terapêuticas broncoscópicas utilizadas em alguns casos. MÉTODOS: Foram estudados 15 pacientes com diagnóstico de GW provenientes do Ambulatório de Vasculites da Disciplina de Pneumologia do HC-FMUSP, encaminhados para a realização de broncoscopia no serviço de Endoscopia Respiratória do HC-FMUSP no período de 2003 a 2007. RESULTADOS: Dos 15 pacientes avaliados, 11 eram mulheres (73,33%) com idade média de 34 ± 11,5 anos. Foram encontradas alterações das vias aéreas em 80% dos pacientes, e o achado endoscópico mais frequente foi estenose subglótica (n = 6). Realizou-se broncoscopia terapêutica em três pacientes com estenose subglótica e em outros três com estenose brônquica, todos apresentando bons resultados. CONCLUSÃO: A broncoscopia permite diagnóstico, acompanhamento e tratamento das lesões de vias aéreas na GW, constituindo-se um recurso terapêutico pouco invasivo em casos selecionados.

INTRODUCTION: Wegener's granulomatosis (WG) is a form of systemic vasculitis that involves primarily the upper and lower airways and the kidneys. The most frequent airway manifestations include subglottic stenosis and inflammation, and tracheal and bronchial stenoses. The endoscopic visualization of the airways is the best tool for assessing, diagnosing and managing those changes. OBJECTIVES: To describe the endoscopic abnormalities found in the airway mucosa of a group of patients with WG undergoing bronchoscopy at Hospital das Clínicas of the Faculdade de Medicina, Universidade de São Paulo (HC-FMUSP), and to report the therapeutic bronchoscopic interventions used in some cases. METHODS: The study assessed 15 patients diagnosed with GW from the Vasculitis Outpatient Clinic of the Department of Pulmonology, HC-FMUSP, referred for bronchoscopy at the Service of Respiratory Endoscopy, HC-FMUSP, from 2003 to 2007. RESULTS: Fifteen patients were studied [11 females (73.33%)]; mean age, 34 ± 11.5 years. Airway changes were found in 80% of the patients, and the most frequent endoscopic finding was subglottic stenosis (n = 6). Therapeutic bronchoscopy was performed in three patients with subglottic stenosis and in other three patients with bronchial stenosis, all showing good results. CONCLUSION: Bronchoscopy allows for diagnosing, monitoring, and treating the airway lesions in WG, being a minimally invasive therapeutic option in selected cases.

OBJECTIVE: The aim of this study was to quantify the interaction between increased intra-abdominal pressure and Positive-End Expiratory Pressure. METHODS: In 30 mechanically ventilated ICU patients with a fixed tidal volume, respiratory system plateau and abdominal pressure were measured at a Positive-End Expiratory Pressure level of zero and 10 cm H2O. The measurements were repeated after placing a 5 kg weight on the patients' belly. RESULTS: After the addition of 5 kg to the patients' belly at zero Positive-End Expiratory Pressure, both intra-abdominal pressure (p<0.001) and plateau pressures (p=0.005) increased significantly. Increasing the Positive-End Expiratory Pressure levels from zero to 10 cm H2O without weight on the belly did not result in any increase in intra-abdominal pressure (p=0.165). However, plateau pressures increased significantly (p< 0.001). Increasing Positive-End Expiratory Pressure from zero to 10 cm H2O and adding 5 kg to the belly increased intra-abdominal pressure from 8.7 to 16.8 (p<0.001) and plateau pressure from 18.26 to 27.2 (p<0.001). Maintaining Positive-End Expiratory Pressure at 10 cm H2O and placing 5 kg on the belly increased intra-abdominal pressure from 12.3 +/- 1.7 to 16.8 +/- 1.7 (p<0.001) but did not increase plateau pressure (26.6+/-1.2 to 27.2 +/-1.1 -p=0.83). CONCLUSIONS: The addition of a 5kg weight onto the abdomen significantly increased both IAP and the airway plateau pressure, confirming that intra-abdominal hypertension elevates the plateau pressure. However, plateau pressure alone cannot be considered a good indicator for the detection of elevated intra-abdominal pressure in patients under mechanical ventilation using PEEP. In these patients, the intra-abdominal pressure must also be measured.

Severe pulmonary involvement in malaria has been frequently reported in cases of Plasmodium falciparum infection, but rarely in vivax malaria. Among the 11 previous cases of vivax-related severe respiratory involvement described in the literature, all except one developed it after the beginning of anti-malarial treatment; these appear to correspond to an exacerbation of the inflammatory response. We report the case of a 43-year-old Brazilian woman living in a malaria-endemic area, who presented acute respiratory distress syndrome (ARDS) caused by P. vivax before starting anti-malarial treatment. The diagnosis was made based on microscopic methods. A negative rapid immunochromatographic assay, based on the detection of Histidine Rich Protein-2 (HRP-2) of P. falciparum, indicated that falciparum malaria was unlikely. After specific anti-plasmodial therapy and intensive supportive care, the patient was discharged from the hospital. We conclude that vivax malaria-associated ARDS can develop before anti-malarial therapy.