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Anti-influenza H1N1/2009 vaccine in autoimmune rheumatic diseases patients

Grant number: 10/10749-0
Support type:Regular Research Grants
Duration: December 01, 2010 - November 30, 2012
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Eloisa Silva Dutra de Oliveira Bonfá
Grantee:Eloisa Silva Dutra de Oliveira Bonfá
Home Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
Assoc. researchers: Alexander Roberto Precioso ; Ana Cristina de Medeiros Ribeiro ; Ana Luisa Garcia Calich ; Carla Gonçalves Schahin Saad ; Cleonice Bueno ; Clovis Artur Almeida da Silva ; Eduardo Ferreira Borba Neto ; Jozélio Freire de Carvalho ; Julio Cesar Bertacini de Moraes ; Lucia Maria de Arruda Campos ; Maria Do Carmo Sampaio Tavares Timenetsky ; Nádia Emi Aikawa ; Rosa Maria Rodrigues Pereira ; Vilma dos Santos Trindade Viana

Abstract

The prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patients. Patients under immunosuppressive therapy have indication for immunization against H1N1 A/California/7/2009-like virus. There are, however, concerns about possibility of reactivation of autoimmune diseases, determine adverse events and insufficient immunogenicity in these patients. The lack of studies evaluating the efficacy and safety of the vaccine against H1N1 A/California/7/2009-like virus in these autoimmune rheumatic patients led to the development of this research. The objectives of this study are to evaluate the humoral response and safety of the vaccine H1N1 A/California/7/2009-like virus in immunosuppressed patients with rheumatic diseases compared to healthy controls. We have recruited 2665 patients including: rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus (SLE), dermatomyositis (DM), with mixed connective tissue disease, systemic vasculitis, systemic sclerosis (SSc) , with Sjögren's syndrome, antiphospholipid syndrome, juvenile idiopathic arthritis, juvenile SLE and juvenile DM, followed at Rheumatology Outpatient Division, HC-FMUSP and Unit Pediatric Rheumatology Children's Institute, HC-FMUSP. The control group recruited was 200 healthy employees of ICHC-FMUSP and 80 healthy children. All subjects were vaccinated against H1N1 A/California/7/2009-like virus (Instituto Butantan/Sanofi Pasteur S.A.). Blood samples were collected to measure levels of antibodies to H1N1 A/California/7/2009-like virus (inhibiting hemagglutination titer) and to characterize autoantibody profile immediately prior to vaccination and 21 days after vaccination. Side effects were also analyzed in this period. All patients with rheumatoid arthritis, spondyloarthritis, SLE, systemic vasculitis, juvenile idiopathic arthritis, juvenile SLE, and juvenile DM were assessed before and 21 days after vaccination for clinical, laboratory parameters of disease activity. Concomitant treatment was evaluated in all patients. (AU)

Scientific publications (16)
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
SAMPAIO-BARROS, PERCIVAL D. . RHEUMATOLOGY, v. 57, n. 10, p. 1721-1725, OCT 2018. Web of Science Citations: 2.
AIKAWA, NADIA E.; FRANCA, IVAN L. A.; RIBEIRO, ANA C.; SALLUM, ADRIANA M. E.; BONFA, ELOISA; SILVA, CLOVIS A. Short and long-term immunogenicity and safety following the 23-valent polysaccharide pneumococcal vaccine in juvenile idiopathic arthritis patients under conventional DMARDs with or without anti-TNF therapy. Vaccine, v. 33, n. 5, p. 604-609, JAN 25 2015. Web of Science Citations: 9.
DE MEDEIROS, D. MARTINS; SILVA, C. A.; BUENO, C.; MEDEIROS RIBEIRO, A. C.; VIANA, V. DOS SANTOS T.; CARVALHO, J. FREIRE; BONFA, E. Pandemic influenza immunization in primary antiphospholipid syndrome (PAPS): a trigger to thrombosis and autoantibody production?. Lupus, v. 23, n. 13, p. 1412-1416, NOV 2014. Web of Science Citations: 5.
AIKAWA, N. E.; TRUDES, G.; CAMPOS, L. M. A.; PEREIRA, R. M. R.; MORAES, J. C. B.; RIBEIRO, A. C.; MIRAGLIA, J.; TIMENETSKY, M. DO CARMO S.; BONFA, E.; SILVA, C. A. Immunogenicity and safety of two doses of a non-adjuvanted influenza A H1N1/2009 vaccine in young autoimmune rheumatic diseases patients. Lupus, v. 22, n. 13, p. 1394-1398, NOV 2013. Web of Science Citations: 7.
SILVA, CLOVIS A.; AIKAWA, NADIA E.; BONFA, ELOISA. Vaccinations in juvenile chronic inflammatory diseases: an update. Nature Reviews Rheumatology, v. 9, n. 9, p. 532-543, SEP 2013. Web of Science Citations: 20.
CAMPOS, LUCIA M. A.; SILVA, CLOVIS A.; AIKAWA, NADIA E.; JESUS, ADRIANA A.; MORAES, JULIO C. B.; MIRAGLIA, JOAO; ISHIDA, MARIA A.; BUENO, CLEONICE; PEREIRA, ROSA M. R.; BONFA, ELOISA. High Disease Activity: An Independent Factor for Reduced Immunogenicity of the Pandemic Influenza A Vaccine in Patients With Juvenile Systemic Lupus Erythematosus. ARTHRITIS CARE & RESEARCH, v. 65, n. 7, p. 1121-1127, JUL 2013. Web of Science Citations: 22.
PASOTO, SANDRA GOFINET; RIBEIRO, ANA CRISTINA; TRINDADE VIANA, VILMA SANTOS; LEON, ELAINE PIRES; BUENO, CLEONICE; LEVY NETO, MAURICIO; PRECIOSO, ALEXANDER ROBERTO; SAMPAIO TAVARES TIMENETSKY, MARIA DO CARMO; BONFA, ELOISA. Short and long-term effects of pandemic unadjuvanted influenza A(H1N1)pdm09 vaccine on clinical manifestations and autoantibody profile in primary Sjogren's syndrome. Vaccine, v. 31, n. 14, p. 1793-1798, APR 3 2013. Web of Science Citations: 12.
RIBEIRO, ANA C.; LAURINDO, IEDA M.; GUEDES, LISSIANE K.; SAAD, CARLA G.; MORAES, JULIO C.; SILVA, CLOVIS A.; BONFA, ELOISA. Abatacept and Reduced Immune Response to Pandemic 2009 Influenza A/H1N1 Vaccination in Patients With Rheumatoid Arthritis. ARTHRITIS CARE & RESEARCH, v. 65, n. 3, p. 476-480, MAR 2013. Web of Science Citations: 45.
AIKAWA, N. E.; CAMPOS, L. M. A.; GOLDENSTEIN-SCHAINBERG, C.; SAAD, C. G. S.; RIBEIRO, A. C.; BUENO, C.; PRECIOSO, A. R.; TIMENETSKY, MDOC; SILVA, C. A. A.; BONFA, E. Effective seroconversion and safety following the pandemic influenza vaccination (anti-H1N1) in patients with juvenile idiopathic arthritis. SCANDINAVIAN JOURNAL OF RHEUMATOLOGY, v. 42, n. 1, p. 34-40, 2013. Web of Science Citations: 15.
MIOSSI, RENATA; FULLER, RICARDO; MORAES, JULIO C. B.; RIBEIRO, ANA CRISTINA M.; SAAD, CARLA G. S.; AIKAWA, NADIA E.; MIRAGLIA, JOAO L.; ISHIDA, MARIA A.; BONFA, ELOISA; CALEIRO, M. TERESA C. Immunogenicity of influenza H1N1 vaccination in mixed connective tissue disease: effect of disease and therapy. Clinics, v. 68, n. 2, p. 129-133, 2013. Web of Science Citations: 7.
AVELINO FRANCA, IVAN LEONARDO; MEDEIROS RIBEIRO, ANA CRISTINA; AIKAWA, NADIA EMI; SCHAIN SAAD, CARLA GONCALVES; BERTACINE MORAES, JULIO CESAR; GOLDSTEIN-SCHAINBERG, CLAUDIA; MAGALHAES LAURINDO, IEDA MARIA; PRECIOSO, ALEXANDER ROBERTO; ISHIDA, MARIA AKIKO; CHRISTOVAM SARTORI, ANA MARLI; SILVA, CLOVIS ARTUR; BONFA, ELOISA. TNF blockers show distinct patterns of immune response to the pandemic influenza A H1N1 vaccine in inflammatory arthritis patients. RHEUMATOLOGY, v. 51, n. 11, p. 2091-2098, NOV 2012. Web of Science Citations: 34.
MIOSSI, RENATA; BENATTI, FABIANA B.; DE SA PINTO, ANA LUCIA; LIMA, FERNANDA R.; BORBA, EDUARDO F.; PRADO, DANILO M. L.; PERANDINI, LUIZ AUGUSTO; GUALANO, BRUNO; BONFA, ELOISA; ROSCHEL, HAMILTON. Using Exercise Training to Counterbalance Chronotropic Incompetence and Delayed Heart Rate Recovery in Systemic Lupus Erythematosus: A Randomized Trial. ARTHRITIS CARE & RESEARCH, v. 64, n. 8, p. 1159-1166, AUG 2012. Web of Science Citations: 31.
BORBA, EDUARDO F.; SAAD, CARLA G. S.; PASOTO, SANDRA G.; CALICH, ANA L. G.; AIKAWA, NADIA E.; RIBEIRO, ANA C. M.; MORAES, JULIO C. B.; LEON, ELAINE P.; COSTA, LUCIANA P.; GUEDES, LISSIANE K. N.; SILVA, CLOVIS A. A.; GONCALVES, CELIO R.; FULLER, RICARDO; OLIVEIRA, SUZIMARA A.; ISHIDA, MARIA A.; PRECIOSO, ALEXANDER R.; BONFA, ELOISA. Influenza A/H1N1 vaccination of patients with SLE: can antimalarial drugs restore diminished response under immunosuppressive therapy?. RHEUMATOLOGY, v. 51, n. 6, p. 1061-1069, JUN 2012. Web of Science Citations: 26.
AIKAWA, NADIA E.; CAMPOS, LUCIA M. A.; SILVA, CLOVIS A.; CARVALHO, JOZELIO F.; SAAD, CARLA G. S.; TRUDES, GUILHERME; DUARTE, ALBERTO; MIRAGLIA, JOAO L.; TIMENETSKY, MARIA DO CARMO S.; VIANA, VILMA S. T.; FRANCA, IVAN L. A.; BONFA, ELOISA; PEREIRA, ROSA M. R. Glucocorticoid: Major Factor for Reduced Immunogenicity of 2009 Influenza A (H1N1) Vaccine in Patients with Juvenile Autoimmune Rheumatic Disease. JOURNAL OF RHEUMATOLOGY, v. 39, n. 1, p. 167-173, JAN 2012. Web of Science Citations: 36.
RIBEIRO, ANA C. M.; GUEDES, LISSIANE K. N.; MORAES, JULIO C. B.; SAAD, CARLA G. S.; AIKAWA, NADIA E.; CALICH, ANA LUISA; FRANCA, IVAN L. A.; CARVALHO, JOZELIO F.; SAMPAIO-BARROS, PERCIVAL D.; GONCALVES, CELIO R.; BORBA, EDUARDO F.; TIMENETSKY, MARIA DO CARMO S.; PRECIOSO, ALEXANDER R.; DUARTE, ALBERTO; BONFA, ELOISA; LAURINDO, IEDA M. M. Reduced seroprotection after pandemic H1N1 influenza adjuvant-free vaccination in patients with rheumatoid arthritis: implications for clinical practice. ANNALS OF THE RHEUMATIC DISEASES, v. 70, n. 12, p. 2144-2147, DEC 2011. Web of Science Citations: 30.
SAAD, CARLA G. S.; BORBA, EDUARDO F.; AIKAWA, NADIA E.; SILVA, CLOVIS A.; PEREIRA, ROSA M. R.; CALICH, ANA LUISA; MORAES, JULIO C. B.; RIBEIRO, ANA C. M.; VIANA, VILMA S. T.; PASOTO, SANDRA G.; CARVALHO, JOZELIO F.; FRANCA, IVAN L. A.; GUEDES, LISSIANE K. N.; SHINJO, SAMUEL K.; SAMPAIO-BARROS, PERCIVAL D.; CALEIRO, MARIA T.; GONCALVES, CELIO R.; FULLER, RICARDO; LEVY-NETO, MAURICIO; TIMENETSKY, MARIA DO CARMO S.; PRECIOSO, ALEXANDER R.; BONFA, ELOISA. Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases. ANNALS OF THE RHEUMATIC DISEASES, v. 70, n. 6, p. 1068-1073, JUN 2011. Web of Science Citations: 51.

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