高危职业人群接种新冠病毒灭活疫苗的安全性和免疫原性：一项随机、平行、对照的临床试验。
Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial.
机构信息
Department of Epidemiology, School of Public Health, Shanxi Medical University, 56 Xinjian South Road, Taiyuan, 030001, Shanxi Province, China.
Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan, China.
出版信息
Infect Dis Poverty. 2021 Dec 22;10(1):138. doi: 10.1186/s40249-021-00924-2.
BACKGROUND
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have a substantial burden on health-care systems around the world. This is a randomized parallel controlled trial for assessment of the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, aiming to determine an appropriate vaccination interval of the vaccine for high-risk occupational population.
METHODS
In an ongoing randomized, parallel, controlled phase IV trial between January and May 2021 in Taiyuan City, Shanxi Province, China, we randomly assigned the airport ground staff and public security officers aged 18 to 59 years to receive two doses of inactivated SARS-CoV-2 vaccine at 14 days, 21 days, or 28 days. The serum neutralizing antibody to live SARS-CoV-2 was performed at baseline and 28 days after immunization. Long-term data are being collected. The primary immunogenicity endpoints were neutralization antibody seroconversion and geometric mean titer (GMT) at 28 days after the second dose. Analysis of variance (ANOVA), chi-square, and logistic regression analysis were used for data analysis.
RESULTS
A total of 809 participants underwent randomization and received two doses of injections: 270, 270, 269 in the 0-14, 0-21, and 0-28 vaccination group, respectively. By day 28 after the second injection, SARS-CoV-2 neutralizing antibody of GMT was 98.4 (95% CI: 88.4-108.4) in the 0-14 group, which was significantly lower compared with 134.4 (95% CI: 123.1-145.7) in the 0-21 group (P < 0.001 vs 0-14 group) and 145.5 (95% CI: 131.3-159.6) in the 0-28 group (P < 0.001 vs 0-14 group), resulting in the seroconversion rates to neutralizing antibodies (GMT ≥ 16) of 100.0% for all three groups, respectively. The intention-to-treat (ITT) analysis yielded similar results. All reported adverse reactions were mild.
CONCLUSIONS
Both a two-dose of inactivated SARS-CoV-2 vaccine at 0-21 days and 0-28 days regimens significantly improved SARS-CoV-2 neutralizing antibody level compared to the 0-14 days regimen in high-risk occupational population, with seroconversion rates of 100.0%.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR2100041705, ChiCTR2100041706. Registered 1 January 2021, www.chictr.org.cn .
背景
严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染和由此导致的 2019 年冠状病毒病（COVID-19）给全球卫生保健系统带来了巨大负担。这是一项评估灭活 SARS-CoV-2 疫苗免疫原性和安全性的随机平行对照试验，旨在确定高危职业人群接种疫苗的合适间隔。
方法
在 2021 年 1 月至 5 月期间，中国山西省太原市进行了一项正在进行的随机、平行、对照的 IV 期试验，我们将年龄在 18 至 59 岁的机场地勤人员和公安人员随机分配，在 14 天、21 天或 28 天内接受两剂灭活 SARS-CoV-2 疫苗。在基线和免疫接种后 28 天进行针对活 SARS-CoV-2 的血清中和抗体检测。正在收集长期数据。主要免疫原性终点为第二次接种后 28 天的中和抗体血清转化率和几何平均滴度（GMT）。采用方差分析（ANOVA）、卡方检验和逻辑回归分析进行数据分析。
结果
共有 809 名参与者接受了随机分组并接受了两剂注射：0-14 组、0-21 组和 0-28 组分别为 270、270 和 269 人。第二次注射后第 28 天，0-14 组 SARS-CoV-2 中和抗体 GMT 为 98.4（95%CI：88.4-108.4），明显低于 0-21 组的 134.4（95%CI：123.1-145.7）（P<0.001 对比 0-14 组）和 0-28 组的 145.5（95%CI：131.3-159.6）（P<0.001 对比 0-14 组），导致中和抗体血清转化率（GMT≥16）分别为 100.0%、100.0%和 100.0%。意向治疗（ITT）分析得出了类似的结果。所有报告的不良反应均为轻度。
结论
高危职业人群接种两剂灭活 SARS-CoV-2 疫苗，间隔 0-21 天和 0-28 天，与 0-14 天方案相比，均可显著提高 SARS-CoV-2 中和抗体水平，血清转化率均为 100.0%。
试验注册
中国临床试验注册中心，ChiCTR2100041705，ChiCTR2100041706。注册于 2021 年 1 月 1 日，www.chictr.org.cn。
Zotero 插件