13 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

    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

    Development of cutaneous lymphoid hyperplasia after topical immunotherapy with squaric acid dibutyl ester

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    We describe a rare case where the development of cutaneous lymphoid hyperplasia was correlated with the topic administration of squaric acid dibutyl ester for immunotherapy in alopecia totalis. Because of the way this disease affects self-esteem and social interaction, an increasing number of patients seek medical attention. Hence, it is important to raise awareness regarding the possible side effects of alopecia treatments

    Erythema chronicum migrans and its clinical variants: a review

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    Erythema chronicum migrans (ECM) is the pathognomonic sign of the early stage of Lyme disease, a tick-borne illness caused by pathogenic species of Borrelia, a genus of bacteria of the spirochete phylum. Lyme disease has a broad spectrum of clinical manifestations that can vary in severity and imitate other diseases. ECM consists in a slow enlarging erythema with central clearing. Its recognition allows to state the diagnosis and prescribe the correct therapy and blood tests. But beside the classical manifestation of ECM, some other peculiar variants are possible, such as the vesiculobullous, the purpuric-hemorrhagic, the urticarial, the panniculitis-erysipeloid and the necrotic variant. It is important to know these variants in order to recognize Lyme disease in its early stage, and to avoid sequelae that can involve joints, hearts, central and peripheral nervous system. We present our experience with iconographic examples and check the literature about the possible manifestations of ECM

    Erythema chronicum migrans and its clinical variants: a review

    Get PDF
    Erythema chronicum migrans (ECM) is the pathognomonic sign of the early stage of Lyme disease, a tick-borne illness caused by pathogenic species of Borrelia, a genus of bacteria of the spirochete phylum. Lyme disease has a broad spectrum of clinical manifestations that can vary in severity and imitate other diseases. ECM consists in a slow enlarging erythema with central clearing. Its recognition allows to state the diagnosis and prescribe the correct therapy and blood tests. But beside the classical manifestation of ECM, some other peculiar variants are possible, such as the vesiculobullous, the purpuric-hemorrhagic, the urticarial, the panniculitis-erysipeloid and the necrotic variant. It is important to know these variants in order to recognize Lyme disease in its early stage, and to avoid sequelae that can involve joints, hearts, central and peripheral nervous system. We present our experience with iconographic examples and check the literature about the possible manifestations of ECM

    Interobserver agreement on dermoscopic features of small basal cell carcinoma (<5 mm) among low-experience dermoscopists

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    The basal cell carcinoma (BCC) assessment in dermoscopy is based on the recognition of specific characteristics synthesized and described as classical and non-classical criteria, but which may not necessarily present all at the same time. Consequently, a deep knowledge in detecting the aforementioned dermoscopic criteria is crucial in diagnosis. The aim of the study was to evaluate which criteria are more frequently recognized among a group of low-experienced dermoscopists when confronted with the difficult diagnosis of BCC with a diameter lower than 5 mm. We examined 100 BCC finding that data displays a full agreement only for one classical criterion, the lack of pigmented network (Fleiss' \u3ba = 1), while among other classical criteria only arborizing vessels and ulceration exhibit a good agreement among observers (Fleiss' \u3ba > 0.40). Analyzing non-classical criteria, only blue-whitish veil and blue in-focus dots show a good agreement among low-experience observers (Fleiss' \u3ba > 0.40). It is evident that in small size BCC classic dermoscopic criteria are often substituted by non-classical criteria, which represent the neoplasm's early phase. Thus, it is of importance, especially for low-experience dermoscopists, to analyze even the non-classical criteria in order to obtain a diagnosis of early BCC. \ua9 2016 Japanese Dermatological Associatio
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