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

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)

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Scientific publications (17)
(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)
CLAUDINO FORMIGA, FRANCISCO FELLIPE; SILVA, CLOVIS ARTUR; PEDROSA, TATIANA DO NASCIMENTO; AIKAWA, NADIA EMI; PASOTO, SANDRA GOFINET; GARCIA, CRISTIANA COUTO; VIDAL CAPAO, ARTUR SILVA; DE OLIVEIRA MARTINS, VICTOR ADRIANO; TONACIO DE PROENCA, ADRIANA CORACINI; FULLER, RICARDO; et al. Influenza A/Singapore (H3N2) component vaccine in systemic lupus erythematosus: A distinct pattern of immunogenicity. Lupus, v. 30, n. 12, . (18/09937-9, 17/14352-7, 10/10749-0, 15/03756-4, 18/16162-3)
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; et al. 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, . (10/10749-0)
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, . (10/10749-0)
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, . (10/10749-0)
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.; et al. 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, . (10/10749-0)
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.; et al. 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, . (10/10749-0)
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, . (10/10749-0, 11/12471-2, 08/58238-4)
SAMPAIO-BARROS, PERCIVAL D.. Pandemic non-adjuvanted influenza A H1N1 vaccine in a cohort of patients with systemic sclerosis. RHEUMATOLOGY, v. 57, n. 10, p. 1721-1725, . (10/10749-0)
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, . (10/10749-0)
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, . (10/10749-0)
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, . (10/10749-0)
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, . (10/10749-0)
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, . (10/10749-0)
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, . (10/10749-0)
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.; et al. 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, . (10/10749-0)
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.; et al. 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, . (10/10749-0)
TONACIO, ADRIANA CORACINI; PEDROSA, TATIANA DO NASCIMENTO; BORBA, EDUARDO FERREIRA; AIKAWA, NADIA EMI; PASOTO, SANDRA GOFINET; RENTE FERREIRA FILHO, JULIO CESAR; SAMPAIO BARROS, MARILIA MANTOVANI; LEON, ELAINE PIRES; FERREIRA SPINA LOMBARDI, SUZETE CLEUSA; MENDRONE JUNIOR, ALFREDO; et al. mmunogenicity and safety of primary fractional-dose yellow fever vaccine in autoimmune rheumatic disease. PLoS Neglected Tropical Diseases, v. 15, n. 11, . (17/14352-7, 10/10749-0, 18/16162-3, 17/11516-9)

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