DANIELI CASTRO OLIVEIRA DE ANDRADE

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Instituto Central, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/17 - Laboratório de Investigação em Reumatologia, Hospital das Clínicas, Faculdade de Medicina

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Autor e Coautores FMUSP-HC Normalizados: ANA CRISTINA DE MEDEIROS RIBEIRO ×

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  • conferenceObject
    Immunogenicity and Safety of an Inactivated Virus Vaccine Against SARS-CoV-2 in Patients with Autoimmune Rheumatic Diseases
    (2021) MEDEIROS-RIBEIRO, Ana; AIKAWA, Nadia; SAAD, Carla Goncalves Schahin; YUKI, Emily Figueiredo Vieira Neves; PEDROSA, Tatiana do Nascimento; FUSCO, Solange; ROJO, Priscila; PEREIRA, Rosa; SHINJO, Samuel; ANDRADE, Danieli; SAMPAIO-BARROS, Percival; RIBEIRO, Carolina; DEVEZA, Giordano; MARTINS, Victor Adriano de Oliveira; SILVA, Clovis Artur; LOPES, Marta; DUARTE, Alberto; ANTONANGELO, Leila; SABINO, Ester; KALLAS, Esper; PASOTO, Sandra Gofinet; BONFA, Eloisa
  • conferenceObject
    CORRELATION BETWEEN SHORTER DISEASE DURATION IN SYSTEMIC SCLEROSIS (SSC) AND ANTI-COLLAGEN TYPE V
    (2014) UGOLINI, M.; MANTOVANI, E.; DINIS, V.; BONOLDI, V.; RIBEIRO, A.; YOSHINARI, N.; ANDRADE, D.
  • article 4 Citação(ões) na Scopus
    Immunogenicity and safety of primary fractional-dose yellow fever vaccine in autoimmune rheumatic diseases
    (2021) TONACIO, Adriana Coracini; PEDROSA, Tatiana do Nascimento; BORBA, Eduardo Ferreira; AIKAWA, Nadia Emi; PASOTO, Sandra Gofinet; FERREIRA FILHO, Julio Cesar Rente; BARROS, Marilia Mantovani Sampaio; LEON, Elaine Pires; LOMBARDI, Suzete Cleusa Ferreira Spina; MENDRONE JUNIOR, Alfredo; AZEVEDO, Adriana de Souza; SCHWARCZ, Waleska Dias; FULLER, Ricardo; YUKI, Emily Figueiredo Neves; LOPES, Michelle Remiao Ugolini; PEREIRA, Rosa Maria Rodrigues; BARROS, Percival Degrava Sampaio; ANDRADE, Danieli Castro Oliveira de; MEDEIROS-RIBEIRO, Ana Cristina de; MORAES, Julio Cesar Bertacini de; SHINJO, Samuel Katsuyuki; MIOSSI, Renata; DUARTE, Alberto Jose da Silva; LOPES, Marta Heloisa; KALLAS, Esper Georges; SILVA, Clovis Artur Almeida da; BONFA, Eloisa
    Background Brazil faced a yellow fever(YF) outbreak in 2016-2018 and vaccination was considered for autoimmune rheumatic disease patients(ARD) with low immunosuppression due to YF high mortality. Objective This study aimed to evaluate, prospectively for the first time, the short-term immunogenicity of the fractional YF vaccine(YFV) immunization in ARD patients with low immunossupression. Methods and Results A total of 318 participants(159 ARD and 159 age- and sex-matched healthy controls) were vaccinated with the fractional-dose(one fifth) of 17DD-YFV. All subjects were evaluated at entry(D0), D5, D10, and D30 post-vaccination for clinical/laboratory and disease activity parameters for ARD patients. Post-vaccination seroconversion rate(83.7%vs.96.6%, p = 0.0006) and geometric mean titers(GMT) of neutralizing antibodies[1143.7 (95%CI 1012.3-1292.2) vs.731 (95%CI 593.6-900.2), p< 0.001] were significantly lower in ARD compared to controls. A lower positivity rate of viremia was also identified for ARD patients compared to controls at D5 (53%vs.70%, p = 0.005) and the levels persisted in D10 for patients and reduced for controls(51%vs.19%, p = 0.0001). The viremia was the only variable associated with seroconvertion. No serious adverse events were reported. ARD disease activity parameters remained stable at D30(p>0.05). Conclusion Fractional-dose 17DD-YF vaccine in ARD patients resulted in a high rate of seroconversion rate(> 80%) but lower than controls, with a longer but less intense viremia. This vaccine was immunogenic, safe and did not induce flares in ARD under low immunosuppression and may be indicated in YF outbreak situations and for patients who live or travel to endemic areas.
  • article 7 Citação(ões) na Scopus
    Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysis
    (2023) ASCEF, Bruna de Oliveira; ALMEIDA, Matheus Oliveira; MEDEIROS-RIBEIRO, Ana Cristina de; ANDRADE, Danieli Castro Oliveira de; OLIVEIRA JUNIOR, Haliton Alves de; SOAREZ, Patricia Coelho de
    Importance Biosimilar drugs are potentially lower-cost versions of biologics that may improve access to therapy. However, there is a lack of adequate systematic reviews demonstrating equivalence between these drugs for the treatment of rheumatoid arthritis (RA). Objectives To assess the efficacy, safety, and immunogenicity associated with biosimilars of adalimumab, etanercept, and infliximab compared with their reference biologics in patients with RA. Data SourcesMEDLINE via PubMed, Embase, Cochrane Central Register of Controlled Trials, and LILACS databases were searched from inception to September 2021. Study Selection Head-to-head randomized clinical trials (RCTs) of biosimilars of adalimumab, etanercept, and infliximab and their biologic reference drugs for RA were assessed. Data Extraction and Synthesis Two authors independently abstracted all data. Meta-analysis was conducted with bayesian random effects using relative risks (RRs) for binary outcomes and standardized mean differences (SMDs) for continuous outcomes, with 95% credible intervals (CrIs) and trial sequential analysis. Specific domains were assessed for the risk of bias in equivalence and noninferiority trials. This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline. Main Outcomes and Measures Equivalence was tested using prespecified margins for the American College of Rheumatology criteria, with at least 20% improvement in the core set measures (ACR20) (ie, RR, 0.94 to 1.06), and for the Health Assessment Questionnaire-Disability Index (HAQ-DI) (ie, SMD, -0.22 to 0.22). Secondary outcomes included 14 items measuring safety and immunogenicity. Results A total of 25 head-to-head trials provided data on 10642 randomized patients with moderate to severe RA. Biosimilars met equivalence with reference biologics in terms of ACR20 response (24 RCTs with 10259 patients; RR, 1.01; 95% CrI, 0.98 to 1.04; tau(2)=0.000) and change of HAQ-DI scores (14 RCTs with 5579 patients; SMD, -0.04; 95% CrI, -0.11 to 0.02; tau(2)=0.002) considering prespecified margins of equivalence. Trial sequential analysis found evidence for equivalence for ACR20 since 2017 and HAQ-DI since 2016. Overall, biosimilars were associated with similar safety and immunogenicity profiles compared with reference biologics. Conclusion and Relevance In this systematic review and meta-analysis, biosimilars of adalimumab, infliximab, and etanercept were associated with clinically equivalent treatment effects compared with their reference biologics for the treatment of RA.
  • article 13 Citação(ões) na Scopus
    Strong response after fourth dose of mRNA COVID-19 vaccine in autoimmune rheumatic diseases patients with poor response to inactivated vaccine
    (2022) AIKAWA, Nadia E.; KUPA, Leonard V. K.; SILVA, Clovis A.; SAAD, Carla G. S.; PASOTO, Sandra G.; YUKI, Emily F. N.; FUSCO, Solange R. G.; SHINJO, Samuel K.; ANDRADE, Danieli C. O.; SAMPAIO-BARROS, Percival D.; PEREIRA, Rosa M. R.; CHASIN, Anna C. S.; SHIMABUCO, Andrea Y.; LUPPINO-ASSAD, Ana P.; LEON, Elaine P.; LOPES, Marta H.; ANTONANGELO, Leila; MEDEIROS-RIBEIRO, Ana C.; BONFA, Eloisa
    Objectives. To assess immunogenicity of a heterologous fourth dose of an mRNA (BNT162b2) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in autoimmune rheumatic diseases (ARD) patients with poor/non-response to inactivated vaccine (Sinovac-CoronaVac). Methods. A total of 164 ARD patients who were coronavirus disease 2019 (COVID-19) poor/non-responders (negative anti-SARS-CoV-2 S1/S2 IgG and/or neutralizing antibodies-NAb) to the third dose of Sinovac-CoronaVac received an additional heterologous dose of mRNA (BNT162b2) 3 months after last dose. IgG and NAb were evaluated before and after the fourth dose. Results. Significant increases were observed after the fourth dose in IgG (66.4 vs 95.1%, P < 0.001), NAb positivity (5.5 vs 83.5%, P < 0.001) and geometric mean titre (29.5 vs 215.8 AU/ml, P < 0.001), and 28 (17.1%) remained poor/non-responders. Patients with negative IgG after a fourth dose were more frequently under rituximab (P = 0 .001) . Negative NAb was associated with older age (P = 0.015), RA (P = 0 .002) , SSc (P = 0 .026) , LEF (P = 0 .01 6) and rituximab use (P = 0.007) . In multiple logistic regression analysis, prednisone dose >= 7.5 mg/day (OR =0.34; P = 0.047) , LEF (OR =0.32, P = 0.036) and rituximab use (OR =0.19, P = 0.022) were independently associated with negative NAb after the fourth vaccine dose. Conclusions. This is the largest study to provide evidence of a remarkable humoral response after the fourth dose of heterologous mRNA SARS-CoV-2 vaccination in ARD patients with poor/non-response to the third dose of an inactivated vaccine. We further identified that treatment, particularly rituximab and prednisone, impaired antibody response to this additional dose.
  • article 22 Citação(ões) na Scopus
    Immunogenicity and safety of two doses of the CoronaVac SARS-CoV-2 vaccine in SARS-CoV-2 seropositive and seronegative patients with autoimmune rheumatic diseases in Brazil: a subgroup analysis of a phase 4 prospective study
    (2022) AIKAWA, Nadia E.; KUPA, Leonard V. K.; PASOTO, Sandra G.; MEDEIROS-RIBEIRO, Ana C.; YUKI, Emily F. N.; SAAD, Carla G. S.; PEDROSA, Tatiana; FULLER, Ricardo; SHINJO, Samuel K.; SAMPAIO-BARROS, Percival D.; ANDRADE, Danieli C. O.; PEREIRA, Rosa M. R.; SEGURO, Luciana P. C.; VALIM, Juliana M. L.; WARIDEL, Filipe; SARTORI, Ana Marli C.; DUARTE, Alberto J. S.; ANTONANGELO, Leila; SABINO, Ester C.; MENEZES, Paulo Rossi; KALLAS, Esper G.; SILVA, Clovis A.; BONFA, Eloisa
    Background We aimed to examine the immunogenicity pattern induced by the inactivated SARS-CoV-2 vaccine CoronaVac (Sinovac Life Sciences, Beijing, China) in SARS-CoV-2 seropositive patients with autoimmune rheumatic diseases compared with seropositive controls, seronegative patients with autoimmune rheumatic diseases, and seronegative controls. Methods CoronavRheum is an ongoing, prospective, controlled, phase 4 study, in which patients aged 18 years or older with autoimmune rheumatic diseases, and healthy controls were recruited from a single site (Rheumatology Division of Hospital das Clinicas, Faculdade de Medicina da Universidade de Sao Paulo) in Sao Paulo, Brazil Participants were vaccinated with two doses of CoronaVac (intramuscular injection, 3 mu g in 0middot5 mL of beta-propiolactone inactivated SARSCoV-2) on day 0 and on day 28. Blood samples were taken pre-vaccination on day 0, day 28, and also on day 69. For this subgroup analysis, participants were defined as being SARS-CoV-2 seropositive or seronegative prevaccination via anti-SARS-CoV-2 spike (S)1 or S2 IgG (cutoff of 15middot0 arbitrary units [AU] per mL) or neutralising antibody titres (cutoff of >= 30%) and were matched for age and sex, via convenience sampling, in a 1:3:1:1 ratio (seropositive patients to seronegative patients to seropositive controls to seronegative controls). The primary outcomes were rates of anti-SARSCoV-2 S1 and S2 IgG seropositivity and SARS-CoV-2 neutralising antibody positivity at day 28 and day 69 and immunogenicity dynamics assessed by geometric mean titres (GMTs) of IgG and median neutralising activity in seropositive patients with autoimmune rheumatic diseases compared with seronegative patients and seropositive and seronegative controls. We assessed safety in all participants randomly selected for this subgroup analysis. This study is registered with ClinicalTrials.gov, NCT04754698, and is ongoing for long-term immunogenicity evaluation. Findings Between Feb 4 and Feb 8, 2021, 1418 patients and 542 controls were recruited, of whom 1685 received two vaccinations (1193 patients and 492 controls). After random sampling, our immunogenicity analysis population comprised 942 participants, of whom 157 were SARS-CoV-2 seropositive patients with autoimmune rheumatic diseases, 157 were seropositive controls, 471 were seronegative patients, and 157 were seronegative controls; the median age was 48 years (IQR 38-56) and 594 (63%) were female and 348 (37%) were male. For seropositive patients and controls, an increase in anti-SARS-CoV-2 S1 and S2 IgG titres (seropositive patients GMT 52middot3 [95% CI 42middot9-63middot9] at day 0 vs 128middot9 [105middot6-157middot4] at day 28; seropositive controls 53middot3 [45middot4-62middot5] at day 0 vs 202middot0 [174middot8-233middot4] at day 28) and neutralising antibody activity (seropositive patients 59% [IQR 39-83] at day 0 vs 82% [54-96] at day 28; seropositive controls 58% [41-79] at day 0 vs 92% [79-96] at day 28), was observed from day 0 to day 28, without further increases from day 28 to day 69 (at day 69 seropositive patients' GMT was 137middot1 [116middot2-161middot9] and neutralising antibody activity was 79% [57-94]); and seropositive controls' GMT was 188middot6 [167middot4-212middot6] and neutralising antibody activity was 92% [75-96]). By contrast, for seronegative patients and controls, the second dose was required for maximum response at day 69, which was lower in seronegative patients than in seronegative controls. GMTs in seronegative patients were 2middot3 (95% CI 2middot2-2middot3) at day 0, 5middot7 (5middot1-6middot4) at day 28, and 29middot6 (26middot4-33middot3) at day 69, and in seronegative controls were 2middot3 (2middot1-2middot5) at day 0, 10middot6 (8middot7-13middot1) at day 28, and 71middot7 (63middot5-81middot0) at day 69; neutralising antibody activity in seronegative patients was 15% (IQR 15-15) on day 0, 15% (15-15) at day 28, and 39% (15-65) at day 69, and in seronegative controls was 15% (15-15) at day 0, 24% (15-37) at day 28, and 61% (37-79) at day 69. Neither seronegative patients nor seronegative controls reached the GMT or antibody activity levels of seropositive patients at day 69. Interpretation By contrast with seronegative patients with autoimmune rheumatic diseases, seropositive patients have a robust response after a single dose of CoronaVac. Our findings raise the possibility that the reduced immunogenicity observed in seronegative patients might not be the optimum response potential to SARS-CoV-2 vaccination, and therefore emphasise the importance of at least a single booster vaccination in these patients.
  • article 4 Citação(ões) na Scopus
    Immunogenicity decay and case incidence six months post Sinovac-CoronaVac vaccine in autoimmune rheumatic diseases patients
    (2022) SILVA, Clovis A.; MEDEIROS-RIBEIRO, Ana C.; KUPA, Leonard V. K.; YUKI, Emily F. N.; PASOTO, Sandra G.; SAAD, Carla G. S.; FUSCO, Solange R. G.; PEREIRA, Rosa M. R.; SHINJO, Samuel K.; HALPERN, Ari S. R.; BORBA, Eduardo F.; SOUZA, Fernando H. C.; GUEDES, Lissiane K. N.; MIOSSI, Renata; BONFIGLIOLI, Karina R.; DOMICIANO, Diogo S.; SHIMABUCO, Andrea Y.; ANDRADE, Danieli C. O.; SEGURO, Luciana P. C.; FULLER, Ricardo; SAMPAIO-BARROS, Percival D.; ASSAD, Ana P. L.; MORAES, Julio C. B.; GOLDENSTEIN-SCHAINBERG, Claudia; GIARDINI, Henrique A. M.; SILVA, Henrique C.; MARTINS, Victor A. O.; VILLAMARIN, Lorena E. B.; NOVELLINO, Renata S.; SALES, Lucas P.; ARAUJO, Carlo S. R.; SILVA, Matheus S. R.; FILHO, Dilson M. N.; LOPES, Marta H.; DUARTE, Alberto J. S.; KALLAS, Esper G.; AIKAWA, Nadia E.; BONFA, Eloisa
    Characterising the response to SARS-CoV-2 post vaccination is critical in the appraisement of the induced immune response, performance and protective potential. Here the authors present data from a phase 4 clinical trial in autoimmune rheumatic disease patients 6 months post second dose of Sinovac-CoronaVac inactivated vaccine that show a marked reduction in antibody particularly in males or those under treatment with immune targeting therapies but saw no rise in COVID-19 disease. The determination of durability and vaccine-associated protection is essential for booster doses strategies, however data on the stability of SARS-CoV-2 immunity are scarce. Here we assess anti-SARS-CoV-2 immunogenicity decay and incident cases six months after the 2(nd) dose of Sinovac-CoronaVac inactivated vaccine (D210) in 828 autoimmune rheumatic diseases patients compared with 207 age/sex-balanced control individuals. The primary outcome is the presence of anti-S1/S2 SARS-CoV-2 IgG at 6 months compared to 6 weeks after 2nd vaccine dose for decay evaluation. Secondary outcomes are presence of neutralizing antibodies, percent inhibition by neutralizing, geometric mean titers and cumulative incident cases at 6 months after 2nd dose. Anti-S1/S2 IgG positivity and titers reduce to 23.8% and 38% in patients (p < 0.001) during the six-month follow up and 20% and 51% in controls (p < 0.001), respectively. Neutralizing antibodies positivity and percent inhibition declines 41% and 54% in patients (p < 0.001) and 39.7% and 47% in controls (p < 0.001). Multivariate logistic regression analysis show males (OR = 0.56;95% CI0.40-0.79), prednisone (OR = 0.56; 95% CI0.41-0.76), anti-TNF (OR = 0.66;95% CI0.45-0.96), abatacept (OR = 0.29; 95% CI0.15-0.56) and rituximab (OR = 0.32;95% CI0.11-0.90) associate with a substantial reduction in IgG response at day 210 in patients. Although cellular immunity was not assessed, a decrease of COVID-19 cases (from 27.5 to 8.1/100 person-years; p < 0.001) is observed despite the concomitant emergence and spread of the Delta variant. Altogether we show a reduction in immunity 6-months of Sinovac-CoronaVac 2nd dose, particularly in males and those under immunosuppressives therapies, without a concomitant rise in COVID-19 cases. (CoronavRheum clinicaltrials.gov:NCT04754698).
  • article 29 Citação(ões) na Scopus
    Increment of immunogenicity after third dose of a homologous inactivated SARS-CoV-2 vaccine in a large population of patients with autoimmune rheumatic diseases
    (2022) AIKAWA, Nadia Emi; KUPA, Leonard de Vinci Kanda; MEDEIROS-RIBEIRO, Ana Cristina; SAAD, Carla Goncalves Schahin; YUKI, Emily Figueiredo Neves; PASOTO, Sandra Gofinet; ROJO, Priscila Tagliaferro; PEREIRA, Rosa Maria Rodrigues; SHINJO, Samuel Katsuyuki; SAMPAIO-BARROS, Percival Degrava; ANDRADE, Danieli Castro Oliveira; HALPERN, Ari Stiel Radu; FULLER, Ricardo; SOUZA, Fernando Henrique Carlos; GUEDES, Lissiane Karine Noronha; ASSAD, Ana Paula Luppino; MORAES, Julio Cesar Bertacini de; LOPES, Michelle Remiao Ugolini; MARTINS, Victor Adriano de Oliveira; BETANCOURT, Lorena; RIBEIRO, Carolina Torres; SALES, Lucas Peixoto; BERTOGLIO, Isabela Maria; BONOLDI, Virginia Lucia Nazario; MELLO, Renata Lys Pinheiro; BALBI, Gustavo Guimaraes Moreira; SARTORI, Ana Marli Christovam; ANTONANGELO, Leila; SILVA, Clovis Artur; BONFA, Eloisa
    Objective To determine the immunogenicity of the third dose of CoronaVac vaccine in a large population of patients with autoimmune rheumatic diseases (ARD) and the factors associated with impaired response. Methods Adult patients with ARD and age-balanced/sex-balanced controls (control group, CG) previously vaccinated with two doses of CoronaVac received the third dose at D210 (6 months after the second dose). The presence of anti-SARS-CoV-2 S1/S2 IgG and neutralising antibodies (NAb) was evaluated previously to vaccination (D210) and 30 days later (D240). Patients with controlled disease suspended mycophenolate mofetil (MMF) for 7 days or methotrexate (MTX) for 2 weekly doses after vaccination. Results ARD (n=597) and CG (n=199) had comparable age (p=0.943). Anti-S1/S2 IgG seropositivity rates significantly increased from D210 (60%) to D240 (93%) (p<0.0001) in patients with ARD. NAb positivity also increased: 38% (D210) vs 81.4% (D240) (p<0.0001). The same pattern was observed for CG, with significantly higher frequencies for both parameters at D240 (p<0.05). Multivariate logistic regression analyses in the ARD group revealed that older age (OR=0.98, 95% CI 0.96 to 1.0, p=0.024), vasculitis diagnosis (OR=0.24, 95% CI 0.11 to 0.53, p<0.001), prednisone >= 5 mg/day (OR=0.46, 95% CI 0.27 to 0.77, p=0.003), MMF (OR=0.30, 95% CI 0.15 to 0.61, p<0.001) and biologics (OR=0.27, 95% CI 0.16 to 0.46, p<0.001) were associated with reduced anti-S1/S2 IgG positivity. Similar analyses demonstrated that prednisone >= 5 mg/day (OR=0.63, 95% CI 0.44 to 0.90, p=0.011), abatacept (OR=0.39, 95% CI 0.20 to 0.74, p=0.004), belimumab (OR=0.29, 95% CI 0.13 to 0.67, p=0.004) and rituximab (OR=0.11, 95% CI 0.04 to 0.30, p<0.001) were negatively associated with NAb positivity. Further evaluation of COVID-19 seronegative ARD at D210 demonstrated prominent increases in positivity rates at D240 for anti-S1/S2 IgG (80.5%) and NAb (59.1%) (p<0.0001). Conclusions We provide novel data on a robust response to the third dose of CoronaVac in patients with ARD, even in those with prevaccination COVID-19 seronegative status. Drugs implicated in reducing immunogenicity after the regular two-dose regimen were associated with non-responsiveness after the third dose, except for MTX.
  • article 12 Citação(ões) na Scopus
    Immunogenicity, safety, and antiphospholipid antibodies after SARS-CoV-2 vaccine in patients with primary antiphospholipid syndrome
    (2022) SIGNORELLI, Flavio; BALBI, Gustavo Guimaraes Moreira; AIKAWA, Nadia E.; SILVA, Clovis A.; KUPA, Leonard de Vinci Kanda; MEDEIROS-RIBEIRO, Ana C.; YUKI, Emily F. N.; PASOTO, Sandra G.; SAAD, Carla G. S.; BORBA, Eduardo F.; SEGURO, Luciana Parente Costa; PEDROSA, Tatiana; OLIVEIRA, Vitor Antonio de Angeli; COSTA, Ana Luisa Cerqueira de Sant'Ana; RIBEIRO, Carolina T.; SANTOS, Roseli Eliana Beseggio; ANDRADE, Danieli Castro Oliveira; BONFA, Eloisa
    Objective Coronavirus disease 19 (COVID-19) has an increased risk of coagulopathy with high frequency of antiphospholipid antibodies (aPL). Recent reports of thrombosis associated with adenovirus-based vaccines raised concern that SARS-CoV-2 immunization in primary antiphospholipid syndrome (PAPS) patients may trigger clotting complications. Our objectives were to assess immunogenicity, safety, and aPL production in PAPS patients, after vaccinating with Sinovac-CoronaVac, an inactivated virus vaccine against COVID-19. Methods This prospective controlled phase-4 study of PAPS patients and a control group (CG) consisted of a two-dose Sinovac-CoronaVac (D0/D28) and blood collection before vaccination (D0), at D28 and 6 weeks after second dose (D69) for immunogenicity/aPL levels. Outcomes were seroconversion (SC) rates of anti-SARS-CoV-2 S1/S2 IgG and/or neutralizing antibodies (NAb) at D28/D69 in naive participants. Safety and aPL production were also assessed. Results We included 44 PAPS patients (31 naive) and 132 CG (108 naive) with comparable age (p=0.982) and sex (p>0.999). At D69, both groups had high and comparable SC (83.9% vs. 93.5%, p=0.092), as well as NAb positivity (77.4% vs. 78.7%, p=0.440), and NAb-activity (64.3% vs. 60.9%, p=0.689). Thrombotic events up to 6 months or other moderate/severe side effects were not observed. PAPS patients remained with stable aPL levels throughout the study at D0 vs. D28 vs. D69: anticardiolipin (aCL) IgG (p=0.058) and IgM (p=0.091); anti-beta-2 glycoprotein I (a beta 2GPI) IgG (p=0.513) and IgM (p=0.468). Conclusion We provided novel evidence that Sinovac-CoronaVac has high immunogenicity and safety profile in PAPS. Furthermore, Sinovac-CoronaVac did not trigger thrombosis nor induced changes in aPL production.
  • article 2 Citação(ões) na Scopus
    Effect of an exercise bout before the booster dose of an inactivated SARS-CoV-2 vaccine on immunogenicity in immunocompromised patients
    (2022) GUALANO, Bruno; SAAD, Carla G. S.; SIECZKOWSKA, Sofia M.; LEMES, Italo Ribeiro; SILVA, Rafael Pires da; PINTO, Ana J.; MAZZOLANI, Bruna C.; I, Fabiana Smaira; GIL, Saulo; OLIVEIRA-JUNIOR, Gersiel; AIKAWA, Nadia E.; MEDEIROS-RIBEIRO, Ana C.; SILVA, Clovis A.; YUKI, Emily F. N.; PASOTO, Sandra G.; PEREIRA, Rosa Maria R.; SHINJO, Samuel K.; ANDRADE, Danieli C. O.; SAMPAIO-BARROS, Percival D.; ROSCHEL, Hamilton; BONFA, Eloisa
    This randomized controlled study aimed to investigate whether a single bout of exercise before the homologous booster dose of a SARS-CoV-2 inactivated vaccine could enhance immunogenicity in patients with spondyloarthritis. We selected 60 consecutive patients with spondyloarthritis (SpA). Patients assigned to the intervention group performed an exercise bout comprising three exercises. Then, they remained at rest for 1 h before vaccination. The control group remained at rest before vaccination. Immunogenicity was assessed before (Pre) and 1 mo after (Post) the booster using seropositivity rates of total anti-SARS-CoV-2 S1/S2 IgG, geometric mean titers of anti-S1/S2 IgG (GMT), frequency of neutralizing antibodies (NAb) positivity, and NAb activity. At Pre, 16 patients from the exercise group and 16 patients from the control group exhibited seropositivity for IgG (59% vs. 57.1%), and 1 mo after the booster dose, seropositivity occurred in 96% versus 100% of the cases. Only 10 patients from the exercise group and 12 patients from the control group showed positive NAb serology at Pre (37% vs. 42.8%). One month following the booster, NAb positivity was 96% versus 93%. GMT was comparable between groups at Pre. At Post, GMT increased similarly in both groups. Likewise, NAb activity was similar between groups at Pre and increased similarly in both of them as a result of the booster (47.5% vs. 39.9%). In conclusion, a single bout of exercise did not enhance immunogenicity to a homologous booster dose of an inactivated SARS-CoV-2 vaccine among patients with spondyloarthritis. NEW & NOTEWORTHY We tested the role of exercise as an adjuvant to a booster of a COVID-19 vaccine. Immunocompromised patients were immunized after an acute bout of exercise or not. Patients exhibited an excellent immunogenicity in response to