疫苗的安全性和有效性ChAdOx1 nCoV-19 (AZD1222)对SARS-CoV-2:临时分析四个随机对照试验在巴西、南非和英国。

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疫苗的安全性和有效性ChAdOx1 nCoV-19 (AZD1222)对SARS-CoV-2:临时分析四个随机对照试验在巴西、南非和英国。

柳叶刀》。2020年12月8日。pii: s0140 - 6736 (20) 32661 - 1。doi: 10.1016 / s0140 - 6736 (20) 32661 - 1。

PubMed ID
33306989 (在PubMed
]
文摘

背景:一个安全、有效的疫苗严重急性呼吸系统综合症冠状病毒2 (SARS-CoV-2),如果部署高覆盖率,可能导致COVID-19流行病的控制。我们的安全性和有效性评估ChAdOx1 nCoV-19疫苗合用的临时分析四个试验。方法:分析包括数据从四个正在进行的蒙蔽,随机,对照试验在英国,巴西和南非。18岁及以上的参与者被随机分配(1:1)ChAdOx1 nCoV-19疫苗或控制(脑膜炎球菌A组C W,和Y结合疫苗或盐水)。参与者ChAdOx1 nCoV-19组两剂包含5 x 10(10)病毒颗粒(标准剂量;SD / SD队列);在英国的一个子集试验收到了一半剂量作为第一剂量(低剂量)和标准剂量作为他们的第二个剂量(LD / SD队列)。主要功效分析包括症状COVID-19与核酸扩增检测呈阳性血清反应阴性的参与者拭子超过14天之后第二个剂量的疫苗。参与者分析根据治疗收到,数据截止于2020年11月4日。疫苗功效计算1 -相对风险来源于一个健壮的泊松回归模型根据年龄进行调整。 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.

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