一种针对新冠病毒的全病毒灭活疫苗QazCovid-in®在健康成年人中的疗效和安全性：一项多中心、随机、单盲、安慰剂对照的3期临床试验，随访6个月。
Efficacy and safety of an inactivated whole-virion vaccine against COVID-19, QazCovid-in®, in healthy adults: A multicentre, randomised, single-blind, placebo-controlled phase 3 clinical trial with a 6-month follow-up.
作者信息
Khairullin Berik, Zakarya Kunsulu, Orynbayev Mukhit, Abduraimov Yergali, Kassenov Markhabat, Sarsenbayeva Gulbanu, Sultankulova Kulyaisan, Chervyakova Olga, Myrzakhmetova Balzhan, Nakhanov Aziz, Nurpeisova Ainur, Zhugunissov Kuandyk, Assanzhanova Nurika, Nurabayev Sergazy, Kerimbayev Aslan, Yershebulov Zakir, Burashev Yerbol, Kulmagambetov Ilyas, Davlyatshin Timur, Sergeeva Maria, Buzitskaya Zhanna, Stukova Marina, Kutumbetov Lespek
机构信息
Research Institute of Biological Safety Problems of the Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan, Gvardeysk, Kazakhstan.
Centre for Clinical Medicine and Research, Almaty, Kazakhstan.
出版信息
EClinicalMedicine. 2022 Jun 25;50:101526. doi: 10.1016/j.eclinm.2022.101526. eCollection 2022 Aug.
BACKGROUND
Vaccination remains the primary measure to prevent the spread of the SARS-CoV-2 virus, further necessitating the use of effective licensed vaccines.
METHODS
From Dec 25, 2020, to July 11, 2021, we conducted a multicenter, randomised, single-blind, placebo-controlled phase 3 efficacy trial of the QazCovid-in® vaccine with a 180-day follow-up period in three clinical centres in Kazakhstan. A total of 3000 eligible participants aged 18 years or older were randomly assigned (4:1) to receive two doses of the vaccine (5 μg each, 21 days apart) or placebo administered intramuscularly. QazCovid-in® is a whole-virion formaldehyde-inactivated anti-COVID-19 vaccine, adjuvanted with aluminium hydroxide. The primary endpoint was the incidence of symptomatic cases of the SARS-CoV-2 infection confirmed by RT-PCR starting from day 14 after the first immunisation. The trial was registered with ClinicalTrials.gov NCT04691908.
FINDINGS
The QazCovid-in® vaccine was safe over the 6-month monitoring period after two intramuscular immunisations inducing only local short-lived adverse events. The concomitant diseases of participants did not affect the vaccine safety. Out of 2400 vaccinated participants, 31 were diagnosed with COVID-19; 43 COVID-19 cases were recorded in 600 placebo participants with onset of 14 days after the first dose within the 180-day observation period. Only one severe COVID-19 case was identified in a vaccine recipient with a comorbid chronic heart failure. The protective efficacy of the QazCovid-in® vaccine reached 82·0% (95% CI 71.1-88.5) within the 180-day observation period.
INTERPRETATION
Two immunisations with the inactivated QazCovid-in® vaccine achieved 82·0% (95% CI 71.1-88.5) protective efficacy against COVID-19 within a 180-day follow-up period.
FUNDING
The work was funded by the Science Committee of the Ministry of Education and Science of Kazakhstan within the framework of the Scientific and Technical Program "Development of a vaccine against coronavirus infection COVID-19". State registration number 0.0927.
背景
接种疫苗仍然是预防严重急性呼吸综合征冠状病毒2（SARS-CoV-2）病毒传播的主要措施，因此进一步需要使用有效的获批疫苗。
方法
2020年12月25日至2021年7月11日，我们在哈萨克斯坦的三个临床中心进行了一项多中心、随机、单盲、安慰剂对照的3期疗效试验，对QazCovid-in®疫苗进行了为期180天的随访。共有3000名18岁及以上的符合条件的参与者被随机分配（4:1）接受两剂疫苗（每剂5μg，间隔21天）或肌肉注射安慰剂。QazCovid-in®是一种全病毒甲醛灭活抗2019冠状病毒病疫苗，佐以氢氧化铝。主要终点是从首次免疫后第14天开始，经逆转录聚合酶链反应（RT-PCR）确诊的SARS-CoV-2感染症状性病例的发生率。该试验已在ClinicalTrials.gov注册，注册号为NCT04691908。
结果
在两次肌肉注射后的6个月监测期内，QazCovid-in®疫苗是安全的，仅引起局部短期不良事件。参与者的合并疾病不影响疫苗安全性。在2400名接种疫苗的参与者中，31人被诊断为2019冠状病毒病；在600名安慰剂参与者中，有43例2019冠状病毒病病例在180天观察期内首次给药后14天内发病。在一名合并慢性心力衰竭的疫苗接种者中仅发现1例严重2019冠状病毒病病例。在180天观察期内，QazCovid-in®疫苗的保护效力达到82.0%（95%置信区间71.1-88.5）。
解读
灭活的QazCovid-in®疫苗两次接种在180天随访期内对2019冠状病毒病的保护效力达到82.0%（95%置信区间71.1-88.5）。
资助
这项工作由哈萨克斯坦教育和科学部科学委员会在“开发抗冠状病毒感染2019冠状病毒病疫苗”科技计划框架内资助。国家注册号0.0927。
Zotero 插件