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Doctoral Thesis
DOI
10.11606/T.5.2013.tde-03122013-113148
Document
Author
Full name
Vanessa Ramos Guissa
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2013
Supervisor
Committee
Silva, Clovis Artur Almeida da (President)
Adde, Fabiola Villac
Len, Cláudio Arnaldo
Lotito, Ana Paola Navarrette
Pastorino, Antonio Carlos
Title in Portuguese
Imugenicidade e segurança da vacina contra influenza A H1N1/2009 em pacientes com dermatomiosite juvenil
Keywords in Portuguese
Adolescente
Criança
Dermatomiosite
Imunidade humoral
Vacinação
Vírus da influenza A subtipo H1N1
Abstract in Portuguese
Objetivos: Avaliar a imunogenicidade e segurança da vacina anti-influenza A/H1N1 2009 em pacientes com dermatomiosite juvenil (DMJ) comparados com controles saudáveis e a possível associação entre taxas de soroconversão com dados demográficos, enzimas musculares, escores da DMJ, linfopenia e tratamento nos pacientes com DMJ atendidos em dois serviços de Reumatologia Pediátrica. Métodos: Trinta pacientes com DMJ entre 9 e 21 anos e 81 controles saudáveis foram imunizados com a vacina anti-influenza A H1N1/2009 sem adjuvante. Todos foram avaliados pré e 21 dias após a vacinação. As taxas de soroproteção e soroconversão, a média geométrica dos títulos de anticorpos (MGT) e o fator de aumento (FA) na MGT foram calculados. Foram analisados os eventos adversos (EAs), assim como: enzimas musculares, instrumentos de força muscular, presença de linfopenia e tratamento atual da DMJ. Resultados: Pacientes com DMJ e controles foram comparáveis em relação à mediana de idade atual [15,5 (9- 21) vs. 15 (9-21) anos, p=0,511] e frequência do sexo feminino (63% vs. 51%, p=0,286). A mediana do tempo de duração da DMJ foi de 5,5 (2-17) anos. Após a imunização, as taxas de soroconversão foram significantemente menores em pacientes com DMJ comparados com controles saudáveis (86,7% vs. 97,5%, p=0,044), enquanto soroproteção (p=0,121), MGT (p=0,992) e FA na MGT (p=0,827) foram semelhantes entre os grupos. As avaliações clínicas e laboratoriais na DMJ mostraram que as medianas dos escores de avaliação da atividade doença e enzimas musculares permaneceram estáveis no período do estudo (p > 0,05). Uma alta frequência de curso clínico crônico da doença foi observada em pacientes que não apresentaram soroconversão em comparação aos pacientes soroconvertidos (100% vs. 27%, p=0,012). Em relação à influência do tratamento, baixas taxas de soroconversão foram observadas em pacientes em uso de metotrexate (100% vs. 38%, p=0,036) e associação de prednisona, metotrexate e ciclosporina (50% vs. 4%, p=0,039). EAs locais e/ou sistêmicos foram leves e similares entre pacientes e controles (p > 0,05). Conclusão: Este foi o primeiro estudo que avaliou a vacina anti-influenza A H1N1/2009 na DMJ, identificando que o curso crônico da doença e a terapia imunossupressora são fatores que podem prejudicar a resposta humoral nos pacientes. Uma única dose da vacina foi soroprotetora nos pacientes avaliados, sem evidências de efeitos deletérios na atividade da doença
Title in English
Immunogenicity and safety of the influenza A H1N1/2009 vaccine in juvenile dermatomyositis patients
Keywords in English
Adolescent
Child
Dermatomyositis
Humoral immunity
Influenza A Virus H1N1 subtype
Vaccination
Abstract in English
Objectives: To assess the immunogenicity and safety of influenza A H1N1/2009 vaccine in juvenile dermatomyositis (JDM) patients compared to age-matched controls and the possible association of seroconversion rates whith demographic, muscle enzymes, JDM scores, lymphopenia and treatment in JDM patients routinely followed at two Pediatric Rheumatology Units. Methods: Thirty JDM patients between 9 and 21 years old and 81 healthy age-matched controls were vaccinated with non-adjuvanted influenza A H1N1/2009 vaccine. All participants were evaluated pre- and 21 days postvaccination. Seroconversion and seroprotection rates, geometric mean titres (GMT) and factor increase (FI) in GMT were assessed. Adverse events, as well as muscle enzymes, JDM scores, lymphopenia and current treatment in JDM were also evaluated. Results: JDM patients and healthy controls had similar median of current age [15.5 (9-21) vs. 15 (9-21) years, p=0.511] and frequencies of female gender (63% vs. 51%, p=0.286). The median disease duration of JDM was 5.5 (2-17) years. After immunization, seroconversion rate was significantly lower in JDM patients compared to age-matched controls (86.7 vs. 97.5%, p=0.044), whereas seroprotection (p=0.121), GMT (p=0.992) and FI in GMT (p=0.827) were similar in both groups. Clinical and laboratorial evaluations revealed that JDM scores and muscle enzymes remained stable throughout the study (p > 0.05). A higher frequency of chronic course was observed in non-seroconvert compared to seroconverted (100% vs. 27%, p=0.012). Regarding treatment, a lower rate of seroconversion was observed in patients treated with methotrexate (100% vs. 38%, p=0.036) and in those with a combination of prednisone, methotrexate and cyclosporine (50% vs. 4%, p=0.039). Local and systemic adverse events were mild and similar in JDM patients and controls (p > 0.05). Conclusions: This was the first study that evaluated the influenza A H1N1/2009 vaccine in JDM, identified that chronic course and immunosuppressive therapy were factors hampering immune response in patients. A single dose of non-adjuvanted influenza A/H1N1 2009 vaccine was seroprotective in assessed patients with no evident deleterious effect in disease itself
 
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Publishing Date
2013-12-05
 
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