18 research outputs found

    Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

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    BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

    Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

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    Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials

    Biochemical parameters of the giant anteater (Myrmecophaga tridactyla Linnaeus, 1758) of the Brazilian Cerrado

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    ABSTRACT: The giant anteater (Myrmecophaga tridactyla) is classified as a vulnerable species on Brazil’s list of species at risk of extinction mainly due to deforestation and forest fires. This has contributed to a considerable increase in detailed clinical case records of the treatment of wild species at veterinary institutions. However, the paucity of serum biochemical profiles of healthy giant anteaters has made it difficult to evaluate these animals, preventing diagnosis, treatment and prognosis. The objective of this work was to collect data about the biochemical profile of healthy giant anteaters from the Brazilian Cerrado raised in captivity, in order to better understand the physiological characteristics inherent to this species. Eighteen analytes from 12 healthy giant anteaters were measured. The following means and standard deviations were found in the biochemical analyses: albumin 3.29±0.33g/dL, ALT 15.49±7.98 IU/L, amylase 1037.92±149.04 IU/L, AST 21, 12±7.50 IU/L, total cholesterol 62.79±20.08mg/dL, HDL cholesterol 14.73±4.98mg/dL, LDL cholesterol 26.60±11.05mg/dL, VLDL cholesterol 2.14±1.06mg/dL, CK 111.61±70.16 IU/L, creatinine 1.05±0.37mg/dL, iron 194.64±81.17μg/dL, GGT 65.18±54.57 IU/L, glucose 103.71±29.63mg/dL, globulins 2.76±0.36g/dL, lipase 28.80±5.11 IU/L,TSP 6.05±0.56g/dL, triglycerides 10.71±5.29mg/dL, and urea 53.46±18.28mg/dL. The values found in this study can be used as references for the laboratory evaluation of giant anteaters living in conditions similar to those of this study. This is one of the first reports of biochemical examinations on giant anteaters of the Cerrado biome

    DETERMINATION OF PESTICIDE RESIDUES IN BOVINE MILK USING A MODIFIED QuEChERS METHOD AND GC-MS/MS

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    Considering the possibility that pesticides used in cattle raising produce residues in milk and cause harm to public health, this study developed a multiresidue method for determination of pesticide residues in bovine milk, using a modified QuEChERS method for sample preparation, and quantification by GC-MS/MS. The method proved to be efficient, resulting in satisfactory recoveries in the range 71.1 to 117.4%, for 45 of the 48 compounds analyzed with RSD values < 17.3%. The method LOD and LOQ were3.0 and 10.0 µg L-1, respectively, except for cyfluthrin which showed 7.5 and 25.0 µg L-1

    Punção aspirativa por agulha fina como método de coleta de material para a histopatologia no osteossarcoma canino

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    Para a obtenção do diagnóstico definitivo do osteossarcoma realizam-se exames citopatológico e histopatológico. O material para exame citopatológico é coletado através de punção aspirativa por agulha fina (PAAF), já para a realização do exame histopatológico é necessário uma amostra de tamanho maior, geralmente conseguida através de biópsia incisional. Este trabalho tem como objetivo desenvolver uma técnica de coleta de material em cães com suspeita de osteossarcoma através de PAAF para a realização de exame histopatológico. Foram coletadas duas amostras de 12 cães suspeitos de osteossarcoma por PAAF. O material obtido pela primeira coleta foi utilizado para confirmar o diagnóstico através do exame citopatológico, enquanto que o material oriundo da segunda coleta foi fixado em formol a 10% para a análise histopatológica. Quatro das 12 amostras (33,3%) avaliadas histopatologicamente pela metodologia proposta obtiveram também o diagnóstico de osteossarcoma. Esses resultados apontam para uma possível adequação da técnica de coleta de material por PAAF para exame histopatológico.<br>Cytopathologic and histopathologic tests are important to obtain a definitive diagnosis of osteosarcoma. The sample for cytopathological exam is collected through fine-needle aspiration cytology (FNA). On the other hand, histopathological exams need a larger sample that is usually obtained by incisional biopsy. The objective of this article is to develop a FNA technique to biopsy and evaluate histopatologically samples of dogs with suspected osteosarcoma. Two FNS samples were collected from 12 such dogs. Samples obtained in the first procedure were examined cytologically. The material sampled at the second biopsy was fixed in 10% formalin and submitted to histopathological analysis. Four out of the 12 samples (33.3%) examined by the herein proposed method were diagnosed as osteosarcoma. These results indicate a possible adaptation of FNA for histopathological examination
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