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

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

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.

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

Host-guest interaction into the cage of a supramolecular iron-organic complex - Is the process enthalpically or entropically- driven?

We report a calorimetric study of the binding in aqueous solution of some guests (dichloromethane, furan, tetrahydrofuran, 1,4- dioxane and tetrahydropyran) with the cage of the supramolecular iron-organic host ((Fe4L6)-L-II)(4-), where L is formed by 2-formylpyridine and 4,4'-diaminobiphenyl-2,2'-disulfonic acid. This supramolecular iron-organic host has a tetrahedral structure with a cage capable to complex specific guests. The study was carried out by using an isothermal titration calorimeter, allowing the determination of the binding constants between some of the guests with ((Fe4L6)-L-II)(4-). Depending on the molecular nature of the guests their incorporation can be fast or very slow. In this latter case, the rate of energy released during the process was used to determine the kinetic constant for the assemblage between the guests with ((Fe4L6)-L-II)(4-). For the cases of fast encapsulation, the correspondent values for Delta H-298(0), Delta HG(298)(0) and Delta S-298(0) were determined and the thermodynamic driven force was elucidated613619CONSELHO NACIONAL DE DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO - CNPQCOORDENAÇÃO DE APERFEIÇOAMENTO DE PESSOAL DE NÍVEL SUPERIOR - CAPESFUNDAÇÃO DE AMPARO À PESQUISA DO ESTADO DE SÃO PAULO - FAPESP301016/2015-1sem informação2015/25406-

Recomendaciones sobre la vacunación contra SAR S-CoV-2/COVID-19 en pacientes con enfermedad renal crónica y trasplante renal

– Los pacientes con enfermedad renal en todas sus etapas (ERC etapas 1-5, diálisis, trasplante renal) deben ser una población prioritaria en el plan de vacunación contra SARS-CoV-2. – En todos los casos, la vacunación debe administrarse sin importar si los pacientes tuvieron antes COVID-19 o si tienen títulos de IgG positivos para SARS-CoV-2. – Debe vacunarse a todos los pacientes con ERC avanzada, con o sin diálisis crónica, con los esquemas habituales propuestos para las diferentes vacunas disponibles en el medio. – Debe vacunarse a todos los pacientes en lista de espera de trasplante renal. En quienes se encuentran programdos para trasplante inter vivos es deseable que completen la vacunación un mes antes del procedimiento. – Hay que vacunar a todos los pacientes receptores de trasplante renal luego del primer mes del trasplante y aprovechar las situaciones clínicas de estabilidad y menor requerimiento de inmunosupresión. En las situaciones en que se administra timoglobulina o rituximab al trasplante se recomienda diferir la vacunación hasta el tercer mes. Cuando se indica tratamiento contra el rechazo (bolos de metilprednisolona, recambio plasmático terapéutico, gammaglobulina), se recomienda posponer la vacunación al menos dos semanas. – Es preciso vacunar a los pacientes con enfermedades autoinmunitarias (enfermedades autoinmunitarias sistémicas, glomerulopatías), con o sin tratamiento inmunosupresor, de preferencia en el momento en que la enfermedad subyacente esté estable y en el mejor momento de la inmunosupresión

Centro de Línguas do IBILCE

The Language Centre at the Institute of Biosciences, Humanities and Exact Sciences of São José do Rio Preto (CEL/IBILCE) acts as a connection between theory and practice in the training of future foreign languages teachers by providing the external and internal communities the contact with foreign languages as well as their cultures. It provides a space for conducting research on the processes of teaching and learning languages aimed at professional and academic improvement of future teachers and scholars. Therefore, we emphasize that these studies may be developed by junior and senior researchers and through scientific research (PIBIC and Scientific Initiation).O Centro de Ensino de Línguas no Instituto de Biociências, Letras e Ciências Exatas de São José do Rio Preto (CEL/IBILCE) atua como um eixo articulador entre teoria e prática na formação de futuros professores de línguas estrangeiras ao proporcionar às comunidades externa e interna o contato com línguas e culturas estrangeiras. Proporciona um espaço para a realização de pesquisas acerca dos processos de ensinar e aprender línguas, visando ao aprimoramento profissional e acadêmico dos professoresbolsistas. Dessa maneira, ressaltamos que esses estudos poderão ser desenvolvidos por professores-pesquisadores e pelos próprios professores-bolsistas, sob a forma de iniciação científica (PIBIC, Estágio Básico e Iniciação Científica)