Pavel Shaikh Terkis Islam, Yetiskin Hazel, Uygut Muhammet Ali, Aslan Ahmet Furkan, Aydın Günsu, İnan Öznur, Kaplan Büşra, Ozdarendeli Aykut
Department of Microbiology, Medical Faculty, Erciyes University, Kayseri 38280, Turkey.
Vaccine Research, Development and Application Center, Erciyes University, Kayseri 38280, Turkey.
Vaccines (Basel). 2021 Nov 2;9(11):1266. doi: 10.3390/vaccines9111266.
The rapid spread of SARS-CoV-2 with its mutating strains has posed a global threat to safety during this COVID-19 pandemic. Thus far, there are 123 candidate vaccines in human clinical trials and more than 190 candidates in preclinical development worldwide as per the WHO on 1 October 2021. The various types of vaccines that are currently approved for emergency use include viral vectors (e.g., adenovirus, University of Oxford/AstraZeneca, Gamaleya Sputnik V, and Johnson & Johnson), mRNA (Moderna and Pfizer-BioNTech), and whole inactivated (Sinovac Biotech and Sinopharm) vaccines. Amidst the emerging cases and shortages of vaccines for global distribution, it is vital to develop a vaccine candidate that recapitulates the severe and fatal progression of COVID-19 and further helps to cope with the current outbreak. Hence, we present the preclinical immunogenicity, protective efficacy, and safety evaluation of a whole-virion inactivated SARS-CoV-2 vaccine candidate (ERUCoV-VAC) formulated in aluminium hydroxide, in three animal models, BALB/c mice, transgenic mice (K18-hACE2), and ferrets. The hCoV-19/Turkey/ERAGEM-001/2020 strain was used for the safety evaluation of ERUCoV-VAC. It was found that ERUCoV-VAC was highly immunogenic and elicited a strong immune response in BALB/c mice. The protective efficacy of the vaccine in K18-hACE2 showed that ERUCoV-VAC induced complete protection of the mice from a lethal SARS-CoV-2 challenge. Similar viral clearance rates with the safety evaluation of the vaccine in upper respiratory tracts were also positively appreciable in the ferret models. ERUCoV-VAC has been authorized by the Turkish Medicines and Medical Devices Agency and has now entered phase 3 clinical development (NCT04942405). The name of ERUCoV-VAC has been changed to TURKOVAC in the phase 3 clinical trial.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）及其变异毒株的迅速传播，在此次新型冠状病毒肺炎（COVID-19）大流行期间对全球安全构成了威胁。截至2021年10月1日，世界卫生组织（WHO）的数据显示，全球有123种候选疫苗正在进行人体临床试验，超过190种候选疫苗处于临床前研发阶段。目前已批准紧急使用的各类疫苗包括病毒载体疫苗（如腺病毒疫苗，牛津大学/阿斯利康、加马列亚研究所的卫星V疫苗以及强生公司的疫苗）、信使核糖核酸（mRNA）疫苗（莫德纳和辉瑞-BioNTech）以及全病毒灭活疫苗（科兴生物和国药集团）。在全球疫苗分配过程中，新病例不断出现且疫苗短缺的情况下，研发一种能够模拟COVID-19严重和致命病程并有助于应对当前疫情爆发的候选疫苗至关重要。因此，我们展示了一种在氢氧化铝中配制的全病毒灭活SARS-CoV-2候选疫苗（ERUCoV-VAC）在三种动物模型（BALB/c小鼠、转基因小鼠（K18-hACE2）和雪貂）中的临床前免疫原性、保护效力和安全性评估。hCoV-19/土耳其/ERAGEM-001/2020毒株用于ERUCoV-VAC的安全性评估。结果发现，ERUCoV-VAC具有高度免疫原性，能在BALB/c小鼠中引发强烈免疫反应。该疫苗在K18-hACE2小鼠中的保护效力表明，ERUCoV-VAC能使小鼠完全免受致死性SARS-CoV-2攻击。在雪貂模型中，该疫苗在上呼吸道的安全性评估中也显示出类似的病毒清除率，同样值得肯定。ERUCoV-VAC已获得土耳其药品和医疗器械局的批准，现已进入3期临床试验（NCT04942405）。在3期临床试验中，ERUCoV-VAC的名称已更改为TURKOVAC。
