23 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

    Quality of fresh-cut avocado (Persea americana Mill.) stored under different temperatures Qualidade de abacates (Persea americana Mill.) minimally processados armazenados sob diferentes temperaturas

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    The goal of this work was to evaluate the effect of different storage temperatures on the quality maintenance of fresh-cut 'Fortuna' avocado (Persea americana Mill.). The fruit was selected, washed and sanitized with sodium hypochlorite solution (190 ppm total residual chlorinee) for 15 minutes. After that, the tip was cut and the fruit was also cut in halves, peeled and the pit removed, manually. Then the halves were immersed in 0.5% calcium chlorite + 0.5% cysteine solution for 2 minutes, to avoid darkening and packed in rigid plastic covered with 20 micrometer thick plastic wrap (PVC film) with a permeability to O2, CO2 and water vapor of 15,000, 80,000 and 390 cmÂł/mÂČ/day, respectively. The product was stored under 3 different temperatures 0, 5, 10ÂșC and evaluated at 5 different storege periods of 0, 2, 3, 5 and 6 days, in a randomized design in a 3x5 factorial. The storage of fresh-cut avocado at 5ÂșC is the best alternative because it determines better maintenance of quality of the avocado. These presented lower darkening of pulp, better scores for appearance and acceptability, lower softening and polyphenoloxidase activity, in comparison to those stored at 0 and 10ÂșC. The fresh-cut avocados stored at 5ÂșC presented a shelf life of 5 days, based, mainly on, appearance, score 7.3, sited between the concepts "like moderately" and "like very much" on a hedonic scale of 9 points and 86% of acceptability, at the end of 5 days of storage.Objetivou-se avaliar o efeito de diferentes temperaturas de armazenamento na manutenção da qualidade de abacates 'Fortuna' (Persea americana Mill.) minimally processados. Os frutos foram lavados e sanificados em solução de hipoclorito de sĂłdio (190 ppm de cloro residual total) por 15 minutos. Posteriormente, efetuou-se a retirada da extremidade onde se insere o pedĂșnculo, o corte em metades, retirada do caroço e casca, manualmente. Em seguida, as metades foram imersas em solução com cloreto de cĂĄlcio 0,5% + cisteĂ­na 0,5% durante 2 minutos, para prevenção do escurecimento, e entĂŁo acondicionadas em embalagens plĂĄsticas (PET) rĂ­gidas envoltas com filme (PVC) 20 micrometros de espessura e permeabilidade a O2, CO2 e vapor d'ĂĄgua de 15.000, 80.000 e 390 cmÂł/mÂČ/dia respectivamente. Em seguida, foram armazenadas em 3 diferentes temperaturas, 0, 5, 10ÂșC, as quais foram avaliadas em 5 diferentes tempos de armazenamento (0, 2, 3, 5 e 6 dias), seguindo um delineamento inteiramente casualizado fatorial 3 X 5. O armazenamento a 5ÂșC de abacates minimamente processados apresenta-se como a melhor alternativa, pois determinou melhor manutenção da qualidade dos abacates. Estes apresentaram, conjuntamente, menor escurecimento da polpa, melhores notas para aparĂȘncia e aceitabilidade, menor perda da firmeza e atividade da polyphenol oxidase , diferindo-se dos armazenados a 0 e 10ÂșC. Os abacates minimally processados armazenados a 5ÂșC apresentaram vida Ăștil de 5 dias baseando-se, principalmente, na aparĂȘncia nota 7,3, valor este situado entre os conceitos gostei moderadamente e gostei muito na escala hedĂŽnica de 9 pontos e 86% de aceitabilidade, ao final dos 5 dias de armazenamento
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