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1. Immunogenicity decay and case incidence six months post Sinovac-CoronaVac vaccine in autoimmune rheumatic diseases patients

Author

Clovis A. Silva, Ana C. Medeiros-Ribeiro, Leonard V. K. Kupa, Emily F. N. Yuki, Sandra G. Pasoto, Carla G. S. Saad, Solange R. G. Fusco, Rosa M. R. Pereira, Samuel K. Shinjo, Ari S. R. Halpern, Eduardo F. Borba, Fernando H. C. Souza, Lissiane K. N. Guedes, Renata Miossi, Karina R. Bonfiglioli, Diogo S. Domiciano, Andrea Y. Shimabuco, Danieli C. O. Andrade, Luciana P. C. Seguro, Ricardo Fuller, Percival D. Sampaio-Barros, Ana P. L. Assad, Julio C. B. Moraes, Claudia Goldenstein-Schainberg, Henrique A. M. Giardini, Henrique C. Silva, Victor A. O. Martins, Lorena E. B. Villamarin, Renata S. Novellino, Lucas P. Sales, Carlo S. R. Araújo, Matheus S. R. Silva, Dilson M. N. Filho, Marta H. Lopes, Alberto J. S. Duarte, Esper G. Kallas, Nadia E. Aikawa, and Eloisa Bonfa

Subjects
Science
Abstract

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.

Published
2022
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2. Impaired anti-HBV vaccine response in non-cirrhotic chronic HCV is not overcome by double dose regimen: randomized control trial

Author

Roseane P. Medeiros, Norah A. Terrault, Daniel F. Mazo, Claudia P. Oliveira, Jennifer Dodge, Patricia M. Zitelli, Marta H. Lopes, Flair J. Carrilho, and Mário G. Pessoa

Subjects
Seroprotection, Fibrosis, Immunization, Prevention, Specialties of internal medicine, RC581-951
Abstract

Introduction and Objectives: Some studies suggest chronic HCV infection diminishes responses to the anti-HBV vaccine. We evaluated the efficacy of double versus standard dose HBV vaccination among HCV patients without cirrhosis. Patients and Methods: 141 adults with untreated chronic HCV were randomized to HBV vaccination with double dose (40μg) or standard dose (20μg) at 0, 1 and 6 months; 70 healthy HCV-negative patients given standard dose served as controls. Vaccine response was defined by anti-HBs ≥10 mIU/mL. Results: 128 patients (60 double, 68 standard doses) completed the study. Patients were of median age 52 years, 61% female, 60% fibrosis

Published
2023
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3. Strong response after fourth dose of mRNA COVID-19 vaccine in autoimmune rheumatic diseases patients with poor response to inactivated vaccine

Author

Nadia E Aikawa, Leonard V K Kupa, Clovis A Silva, Carla G S Saad, Sandra G Pasoto, Emily F N Yuki, Solange R G Fusco, Samuel K Shinjo, Danieli C O Andrade, Percival D Sampaio-Barros, Rosa M R Pereira, Anna C S Chasin, Andrea Y Shimabuco, Ana P Luppino-Assad, Elaine P Leon, Marta H Lopes, Leila Antonangelo, Ana C Medeiros-Ribeiro, and Eloisa Bonfa

Subjects
Rheumatology, Pharmacology (medical)
Abstract

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 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. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, CoronavRheum #NCT04754698.

Published
2022
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4. Strong response after 4th dose of mRNA COVID-19 vaccine in autoimmune rheumatic diseases patients with poor response to inactivated vaccine

Author

Nadia E, Aikawa, Leonard V K, Kupa, Clovis A, Silva, Carla G S, Saad, Sandra G, Pasoto, Emily F N, Yuki, Solange R G, Fusco, Samuel K, Shinjo, Danieli C O, Andrade, Percival D, Sampaio-Barros, Rosa M R, Pereira, Anna C S, Chasin, Andrea Y, Shimabuco, Ana P, Luppino-Assad, Elaine P, Leon, Marta H, Lopes, Leila, Antonangelo, Ana C, Medeiros-Ribeiro, and Eloisa, Bonfa

Abstract

To assess immunogenicity of a heterologous 4th dose of a mRNA (BNT162b2) SARS-CoV-2 vaccine in autoimmune rheumatic diseases (ARD) patients with poor/non-response to inactivated vaccine (Sinovac-CoronaVac).164 ARD patients who were COVID-19 poor/non-responders (negative anti-SARS-CoV-2 S1/S2 IgG and/or neutralising antibodies-NAb) to the 3rd dose of Sinovac-CoronaVac received an additional heterologous dose of mRNA (BNT162b2) three months after last dose. IgG and NAb were evaluated before and after the 4th dose.Significant increases were observed after 4th dose in IgG (66.4% vs 95.1%, p0.001), NAb positivity (5.5% vs 83.5%, p0.001) and GMT (29.5 vs 215.8 AU/ml, p0.001), and 28 (17.1%) remained poor/non-responders. Patients with negative IgG after 4th dose were more frequently under rituximab (p= 0.001). Negative NAb was associated with older age (p= 0.015), rheumatoid arthritis (p= 0.002), systemic sclerosis (p= 0.026), leflunomide (p= 0.016), and rituximab use (p= 0.007). In multiple logistic regression analysis, prednisone dose ≥7.5 mg/day (OR = 0.34; p= 0.047), leflunomide (OR = 0.32, p= 0.036) and rituximab use (OR = 0.19, p= 0.022) were independently associated with negative NAb after the 4th vaccine dose.This is the largest study to provide evidence of a remarkable humoral response after the 4th dose of heterologous mRNA SARS-CoV-2 vaccination in ARD patients with poor/no-response to the 3rd dose of an inactivated vaccine. We further identified that treatment, particularly rituximab and prednisone, impaired antibody response to this additional dose.ClinicalTrials.gov, https://clinicaltrials.gov, CoronavRheum #NCT04754698.

Published
2022

5. Immunogenicity decay and case incidence six months post Sinovac-CoronaVac vaccine in autoimmune rheumatic diseases patients

Author

Clovis A. Silva, Ana C. Medeiros-Ribeiro, Leonard V. K. Kupa, Emily F. N. Yuki, Sandra G. Pasoto, Carla G. S. Saad, Solange R. G. Fusco, Rosa M. R. Pereira, Samuel K. Shinjo, Ari S. R. Halpern, Eduardo F. Borba, Fernando H. C. Souza, Lissiane K. N. Guedes, Renata Miossi, Karina R. Bonfiglioli, Diogo S. Domiciano, Andrea Y. Shimabuco, Danieli C. O. Andrade, Luciana P. C. Seguro, Ricardo Fuller, Percival D. Sampaio-Barros, Ana P. L. Assad, Julio C. B. Moraes, Claudia Goldenstein-Schainberg, Henrique A. M. Giardini, Henrique C. Silva, Victor A. O. Martins, Lorena E. B. Villamarin, Renata S. Novellino, Lucas P. Sales, Carlo S. R. Araújo, Matheus S. R. Silva, Dilson M. N. Filho, Marta H. Lopes, Alberto J. S. Duarte, Esper G. Kallas, Nadia E. Aikawa, and Eloisa Bonfa

Subjects
Male, Multidisciplinary, COVID-19 Vaccines, SARS-CoV-2, Incidence, General Physics and Astronomy, COVID-19, Viral Vaccines, General Chemistry, Antibodies, Viral, Antibodies, Neutralizing, General Biochemistry, Genetics and Molecular Biology, Abatacept, Vaccines, Inactivated, Immunoglobulin G, Rheumatic Diseases, Humans, Prednisone, Tumor Necrosis Factor Inhibitors, Rituximab
Abstract

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 2nd 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 p p p

Published
2021

6. Double-dose hepatitis B vaccination in cirrhotic patients on a liver transplant waiting list

Author

Patricia R. Bonazzi, Telesforo Bacchella, Angela C. Freitas, Karina T. Osaki, Marta H. Lopes, Maristela P. Freire, Marcel C.C. Machado, and Edson Abdala

Subjects
Vaccine, cirrhotic, hepatitis B, liver transplant, Infectious and parasitic diseases, RC109-216, Microbiology, QR1-502
Abstract

Development of immunity to hepatitis B virus in cirrhotic patients waiting for liver transplantation is highly desirable. Though a double-dose regimen is available, little is know about its effectiveness. We examined the efficacy of double-dose hepatitis B virus vaccination in cirrhotic patients waiting for liver transplantation. We studied 43 patients who were waiting for liver transplantation. They were vaccinated with three doses of 40 mg hepatitis B vaccine at 0, 1 and 6 months; the normal dose is 20 mg. Efficacy was measured based on seroconversion of anti-HBs. Global response to the primary vaccination scheme was 67.5% (29 patients). Forty-one per cent of responders had anti-HBs titers above 1,000 IU/mL. No factors were associated with response, based on multivariate analysis. The vaccination scheme of 40 mg at 0, 1 and 6 months was superior to conventional vaccination doses (20 mg) for cirrhotic patients on a waiting list for liver transplantation.

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