| Grant number: | 13/19611-0 |
| Support Opportunities: | Regular Research Grants |
| Start date: | March 01, 2014 |
| End date: | February 28, 2017 |
| Field of knowledge: | Health Sciences - Medicine - Maternal and Child Health |
| Principal Investigator: | Maria Teresa de Sande e Lemos Ramos Ascensão Terreri |
| Grantee: | Maria Teresa de Sande e Lemos Ramos Ascensão Terreri |
| Host Institution: | Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil |
| Associated researchers: | Maria Isabel de Moraes Pinto |
Abstract
Immunization of immunnosupressed patients is a subject that remains widely discussed due to the necessary protection of these individuals against agents that they are particularly more susceptible to. The main objective of this study is to evaluate the immunnogenicity and safety of the tetanus, diphtheria and acelullar pertussis (Tdap) in adolescents with systemic lupus erythematosus (JSLE) and juvenile idiopathic arthritis (JIA) taking anti-TNF. The cellular and humoral immunity response to the three vaccine antigens, the side effects of the vaccination, the reactivation or worsening of the disease due to the vaccine, maintenance of the humoral immune response over time and the response to the vaccination related to the immunophenotypic profile and the use of anti-TNF will also be evaluated. This study will be performed at the Universidade Federal de São Paulo, São Paulo, Brazil and will be submitted to the ethics review board of the institution. This is a prospective study where three groups will be assessed: one of adolescents with JSLE, one of adolescents with JIA and another one of healthy adolescents (control group) age and gender matched. Demographic, clinical and laboratorial data will be collected from the patients charts, and also the disease activity and medications in use. One dose of the Tdap vaccine will be prescribed via intramuscular in the non-dominant arm of the adolescents who have had five doses of the whole diphtheria, tetanus and pertussis vaccine (DTP) or the diphtheria and tetanus vaccine (dT) the last dose being at least over five years previously. The tolerability of the vaccine will be assessed by the occurrence of side effects in the first seven days after the vaccination. The safety of the vaccine will be assessed by the occurrence of side effects and the reactivation of the disease (JSLE or JIA). The immunogenicity will be assessed from the immunophenotyping of limphocytes from peripheral blood, blood culture and activation in vitro, evaluation of cytokines of cellular culture and immunoenzimatic assay (ELISA) for the detection of plasmatic antibodies. On admission to the study, a sample of 10 mL of peripheral blood will be collected from each subject in a heparinized tube. Another 5 mL will be collected on day 7 (6-9 days), day 28 (28-42), 6 months (5.5-6.5 months), 12 months (11.5-13 months), 24 months (23.5-25 months) and 36months (35.5-37 months) after the dose of Tdap. From each blood sample, a percentage will be separated, centrifuged and plasma samples will be stored at -80°C until the laboratory work-up. (AU)
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