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

• Grant number: 10/10749-0
• Support Opportunities: Regular Research Grants
• Start date: December 01, 2010
• End date: November 30, 2012
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Eloisa Silva Dutra de Oliveira Bonfá
• Grantee: Eloisa Silva Dutra de Oliveira Bonfá
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated 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

(19)

(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)

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. (10/10749-0)

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, NOV 2012. (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, MAR 2013. (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, JAN 2012. (10/10749-0)

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. (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, SEP 2013. (08/58238-4, 11/12471-2, 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, JUN 2012. (10/10749-0)

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, AUG 2021. (18/09937-9, 17/14352-7, 10/10749-0, 15/03756-4, 18/16162-3)

NADIA EMI AIKAWA; EDUARDO FERREIRA BORBA; VERENA ANDRADE BALBI; ADRIANA MALUF ELIAS SALLUM; IZABEL MANTOVANI BUSCATTI; LUCIA MARIA ARRUDA CAMPOS; KÁTIA TOMIE KOZU; CRISTIANA COUTO GARCIA; ARTUR SILVA VIDAL CAPÃO; ADRIANA CORACINI TONACIO DE PROENÇA; et al. Safety and immunogenicity of influenza A(H3N2) component vaccine in juvenile systemic lupus erythematosus. ADVANCES IN RHEUMATOLOGY, v. 63, 2023-12-18. (17/14352-7, 18/16162-3, 15/03756-4, 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, NOV 2021. (10/10749-0, 17/14352-7, 18/16162-3, 17/11516-9)

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, OCT 2018. (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, NOV 2014. (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, JAN 25 2015. (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, NOV 2013. (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, APR 3 2013. (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, AUG 2012. (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, DEC 2011. (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, JUL 2013. (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, JUN 2011. (10/10749-0)