效应对SARS-CoV-2灭活疫苗的安全性和免疫原性结果:临时的分析2随机临床试验。

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夏,段K,张Y,赵D,张H,谢Z,李X,彭C,张Y,张W,杨Y,陈W,高X,你W,王X, Z, Z,王Y,杨X,张L,黄L,王问,陆J,杨Y,郭J,周W, Wan X,吴C,王W,黄年代,Du J,孟Z,锅,元Z,沈年代,杨郭W X

效应对SARS-CoV-2灭活疫苗的安全性和免疫原性结果:临时的分析2随机临床试验。

《美国医学协会杂志》上。2020年8月13日。pii: 2769612。doi: 10.1001 / jama.2020.15543。

PubMed ID
32789505 (在PubMed
]
文摘

重要性:冠状病毒病疫苗2019 (COVID-19)是急需的。摘要目的:评价尚灭活病毒COVID-19疫苗的安全性和免疫原性。干预措施:在第一阶段试验中,96名参与者被分配给1的3个剂量组(2.5、5、10杯/剂量)和氢氧化铝(明矾)adjuvant-only组每组(n = 24),和接收3肌内注射在天0,28岁,而56。在第二阶段试验中,224名成年人被随机分配至5杯/剂量计划分成两组(注射在0和14天(n = 84)只对明矾(n = 28),和0天、21 (n = 84)和明矾只有[n = 28])。设计、设置和参与者:临时分析正在进行的随机、双盲、安慰剂对照,1和2期临床试验来评估一个灭活COVID-19疫苗。中国河南省进行了试验,在96年(第一阶段)和224(阶段2)年龄18到59岁之间的健康成年人。研究招生开始于2020年4月12日。临时的分析进行了6月16日,2020年,2020年7月27日,和更新。主要结果和措施:主要安全的结果是每次注射后,7天合并后的不良反应,主要免疫原性的结果是中和抗体反应14天全程接种疫苗后,由50%的蚀斑减少中和试验测量与生活严重急性呼吸系统综合症冠状病毒2 (SARS-CoV-2)。结果:320名患者被随机分配(平均年龄42.8岁; 200 women [62.5%]), all completed the trial up to 28 days after the whole-course vaccination. The 7-day adverse reactions occurred in 3 (12.5%), 5 (20.8%), 4 (16.7%), and 6 (25.0%) patients in the alum only, low-dose, medium-dose, and high-dose groups, respectively, in the phase 1 trial; and in 5 (6.0%) and 4 (14.3%) patients who received injections on days 0 and 14 for vaccine and alum only, and 16 (19.0%) and 5 (17.9%) patients who received injections on days 0 and 21 for vaccine and alum only, respectively, in the phase 2 trial. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted. The geometric mean titers of neutralizing antibodies in the low-, medium-, and high-dose groups at day 14 after 3 injections were 316 (95% CI, 218-457), 206 (95% CI, 123-343), and 297 (95% CI, 208-424), respectively, in the phase 1 trial, and were 121 (95% CI, 95-154) and 247 (95% CI, 176-345) at day 14 after 2 injections in participants receiving vaccine on days 0 and 14 and on days 0 and 21, respectively, in the phase 2 trial. There were no detectable antibody responses in all alum-only groups. Conclusions and Relevance: In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2000031809.

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