PRISCILLA RAMOS COSTA
Projetos de Pesquisa
Unidades Organizacionais
LIM/60 - Laboratório de Imunologia Clínica e Alergia, Hospital das Clínicas, Faculdade de Medicina
3 resultados
Resultados de Busca
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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.
- Immunophenotypical Characterization of a Brazilian POIS (Post-Orgasmic Illness Syndrome) Patient: Adding More Pieces to Puzzle(2020) AMICIS, Karine De; COSTA, Priscilla Ramos; FIGO, Daniele Danella; LIMA, Cynthia Mafra Fonsecade De; CASTRO, Fabio Fernandes Morato; KALIL, Jorge; SANTOS, Keity Souza; GALVAO, Clovis Eduardo SantosPost-orgasmic illness syndrome (POIS) is a rare condition characterized by post-ejaculatory symptoms. Here is reported the first Brazilian POIS patient. Immunological investigation did not confirm the previous hypothesis of a hypersensitivity reaction. Cell immunophenotyping comparing healthy individuals produced evidence of abnormalities not associated to clinical manifestations. The patient was submitted to specific immunotherapy with transient clinical response and was referred to a psychologist but did not demonstrate clinical improvement of symptoms. Therefore, etiology of POIS remains unclear.
- Immune effects ofLactobacillus caseiShirota in treated HIV-infected patients with poor CD4+T-cell recovery(2020) TENORE, Simone de Barros; AVELINO-SILVA, Vivian Iida; COSTA, Priscilla Ramos; FRANCO, Lucas M.; SABINO, Ester Cerdeira; KALIL, Jorge; CERQUEIRA, Natalia Barros; NAKAGAWA, Zelinda; KALLAS, Esper GeorgesBackground: HIV infection leads to depletion of intestinal CD4+ T cells, mucosal barrier dysfunction, increased gut permeability and microbial translocation even among patients on suppressive ART. Previous studies suggest probiotics may help restore intestinal function. Methods: In this double-blind, placebo-controlled pilot study, we enrolled HIV-infected patients on suppressive ART with poor CD4+ recovery to address the effect of daily oral use ofLactobacillus caseiShirota (LcS) on CD4+ T-cell count and CD4+/CD8+ ratio at 6 and 12 weeks after treatment initiation; immune activation and intestinal microbiome composition were addressed as secondary outcomes. Results: From January 2015 to July 2016, 48 patients were randomized (1 : 1) to active intervention or placebo. Groups had comparable demographic and clinical characteristics; only CD4+ T-cell nadir was statistically different between groups. All participants were virologically suppressed under ART. At week 6, the increment in CD4+ T-cell count was 17 cells/mu l [interquartile range (IQR) -33 to 74] in the active intervention arm and 4 cells/mu l (IQR -43 to 51) in the placebo arm (P = 0.291); at week 12, the change in CD4+ T-cell count was 8 cells//mu l (IQR -30 to 70) in the active arm and 10 cells//mu l (IQR -50 to 33) among participants allocated to placebo (P = 0.495). Median change in CD4+/CD8+ ratio at week 6 compared with baseline was 0 (IQR -0.04 to 0.05) in the active intervention arm and -0.01 in the placebo arm (IQR -0.06 to 0.03;P = 0.671). At week 12, the change in CD4+/CD8+ ratio was higher in the active product group compared with placebo (respectively 0.07 and 0.01), but this difference failed to reach statistical significance (P = 0.171). We found no significant effects of LcS on immune activation markers, CD4+ and CD8+ subpopulations, sCD14 levels or NK cells at week 12. Finally, we found no statistically significant differences between groups in the change of enteric microbiome at week 12. Conclusion: In this pilot study, we found no statistically significant effect of LcS probiotic on CD4+ T-cell counts, CD4+/CD8+ ratio, immune activation or intestinal microbiome among HIV-infected patients on suppressive ART with poor CD4+ recovery.