SYLVIA COSTA LIMA FARHAT
Projetos de Pesquisa
Unidades Organizacionais
Instituto da Criança, Hospital das Clínicas, Faculdade de Medicina
LIM/05 - Laboratório de Poluição Atmosférica Experimental, Hospital das Clínicas, Faculdade de Medicina
LIM/05 - Laboratório de Poluição Atmosférica Experimental, Hospital das Clínicas, Faculdade de Medicina
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- Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomised placebo-controlled phase 2 trial(2020) KALLAS, Esper G.; PRECIOSO, Alexander Roberto; PALACIOS, Ricardo; THOME, Beatriz; BRAGA, Patricia Emilia; VANNI, Tazio; CAMPOS, Lucia M. A.; FERRARI, Lilian; MONDINI, Gabriella; SALOMAO, Maria da Graca; SILVA, Anderson da; ESPINOLA, Heloisa M.; SANTOS, Joane do Prado; SANTOS, Cecilia L. S.; TIMENETSKY, Maria do Carmo S. T.; MIRAGLIA, Joao Luiz; GALLINA, Neuza M. F.; WEISKOPF, Daniela; SETTE, Alessandro; GOULART, Raphaella; SALLES, Rafael Tavares; MAESTRI, Alvino; SALLUM, Adriana Maluf Elias; FARHAT, Sylvia Costa Lima; SAKITA, Neusa K.; FERREIRA, Juliana C. O. A.; SILVEIRA, Cassia G. T.; COSTA, Priscilla R.; RAW, Isaias; WHITEHEAD, Stephen S.; DURBIN, Anna P.; KALIL, JorgeBackground The Butantan Institute has manufactured a lyophilised tetravalent live-attenuated dengue vaccine Butantan-DV, which is analogous to the US National Institutes of Health (NIH) TV003 admixture. We aimed to assess the safety and immunogenicity of Butantan-DV. Methods We did a two-step, double-blind, randomised placebo-controlled phase 2 trial at two clinical sites in Sao Paulo, Brazil. We recruited healthy volunteers aged 18-59 years; pregnant women, individuals with a history of neurological, heart, lung, liver or kidney disease, diabetes, cancer, or autoimmune diseases, and individuals with HIV or hepatitis C were excluded. Step A was designed as a small bridge-study between Butantan-DV and TV003 in DENV-naive participants. In step A, we planned to randomly assign 50 dengue virus (DENV)-naive individuals to receive two doses of Butantan-DV, TV003, or placebo, given 6 months apart. In step B, we planned to randomly assign 250 participants (DENV-naive and DENV-exposed) to receive one dose of Butantan-DV or placebo. Participants were randomly assigned, by computer-generated block randomisation (block sizes of five); participants in step A were randomly assigned (2:2:1) to receive Butantan-DV, TV003, or placebo and participants in step B were randomly assigned (4:1) to receive Butantan-DV or placebo. Participants and study staff were unaware of treatment allocation. The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat. The primary immunogenicity outcome was seroconversion rates of the DENV-1-4 serotypes measured 91 days after the first vaccination, analysed in the per-protocol population, which included all participants in step A, and all participants included in step B who completed all study visits with serology sample collection. This trial is registered with ClinicalTrials. gov, NCT01696422. Findings Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants. Of the 155 DENV-naive participants, 97 (63%) received Butantan-DV, 17 (11%) received TV003, and 41 (27%) received placebo. Of the 145 DENV-exposed participants, 113 (78%) received Butantan-DV, three (2%) received TV003, and 29 (20%) received placebo. Butantan-DV and TV003 were both immunogenic, well-tolerated, and no serious adverse reactions were observed. In step A, rash was the most frequent adverse event (16 [845] of 19 participants in the Butantan-DV group and 13 [76%] of 17 participants in the TV003 group). Viraemia was similar between the Butantan-DV and TV003 groups. Of the 85 DENV-naive participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis and thus were included in the per-protocol analysis population, 74 (87%) achieved seroconversion to DENV-1, 78 (92%) to DENV-2, 65 (76%) to DENV-3, and 76 (89%) to DENV-4. Of the 101 DENV-exposed participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis, 82 (81%) achieved seroconversion to DENV-1, 79 (78%) to DENV-2, 83 (82%) to DENV-3, and 78 (77%) to DENV-4. Interpretation Butantan-DV and TV003 were safe and induced robust, balanced neutralising antibody responses against the four DENV serotypes. Efficacy evaluation of the Butantan-DV vaccine is ongoing.
- Air pollution and children's health: sickle cell disease(2015) BARBOSA, Silvia Maria de Macedo; FARHAT, Sylvia Costa Lima; MARTINS, Lourdes Conceicao; PEREIRA, Luiz Alberto Amador; SALDIVA, Paulo Hilario Nascimento; ZANOBETTI, Antonella; BRAGA, Alfesio Luis FerreiraThe hallmarks of sickle cell disease are anemia and vasculopathy. The aim of this study was to assess the association between air pollution and children's emergency room visits of sickle cell patients. We adopted a case-crossover design. Daily counts of children's and adolescents' sickle cell disease emergency room visits from the pediatric emergency unit in Sao Paulo, Brazil, were evaluated from September 1999 to December 2004, matching by temperature, humidity and controlling for day of the week. Interquartile range increases of the four-day moving averages of PM10, NO2, SO2, CO, and O-3 were associated with increases of 18.9% (95%CI: 11.2-26.5), 19% (95%CI: 8.3-29.6), 14.4% (95%CI: 6.5-22.4), 16,5% (95%CI: 8.9-24.0), and 9.8% (95%CI: 1.1-18.6) in total sickle cell emergency room visits, respectively. When the analyses were stratified by pain, PM10 was found to be 40.3% higher than in sickle cell patients without pain symptoms. Exposure to air pollution can affect the cardiovascular health of children and may promote a significant health burden in a sensitive group.
- High-fidelity simulation versus case-based discussion for teaching medical students in Brazil about pediatric emergencies(2015) COUTO, Thomaz Bittencourt; FARHAT, Sylvia C.L.; GEIS, Gary L.; OLSEN, Orjan; SCHVARTSMAN, ClaudioOBJECTIVE: To compare high-fidelity simulation with case-based discussion for teaching medical students about pediatric emergencies, as assessed by a knowledge post-test, a knowledge retention test and a survey of satisfaction with the method. METHODS: This was a non-randomized controlled study using a crossover design for the methods, as well as multiple-choice questionnaire tests and a satisfaction survey. Final-year medical students were allocated into two groups: group 1 participated in an anaphylaxis simulation and a discussion of a supraventricular tachycardia case, and conversely, group 2 participated in a discussion of an anaphylaxis case and a supraventricular tachycardia simulation. Students were tested on each theme at the end of their rotation (post-test) and 4-6 months later (retention test). RESULTS: Most students (108, or 66.3%) completed all of the tests. The mean scores for simulation versus case-based discussion were respectively 43.6% versus 46.6% for the anaphylaxis pre-test (p=0.42), 63.5% versus 67.8% for the post-test (p=0.13) and 61.5% versus 65.5% for the retention test (p=0.19). Additionally, the mean scores were respectively 33.9% versus 31.6% for the supraventricular tachycardia pre-test (p=0.44), 42.5% versus 47.7% for the post-test (p=0.09) and 41.5% versus 39.5% for the retention test (p=0.47). For both themes, there was improvement between the pre-test and the post-test (p<0.05), and no significant difference was observed between the post-test and the retention test (p>0.05). Moreover, the satisfaction survey revealed a preference for simulation (p<0.001). CONCLUSION: As a single intervention, simulation is not significantly different from case-based discussion in terms of acquisition and retention of knowledge but is superior in terms of student satisfaction.