Ghasemi Soheil, Naderi Saffar Kosar, Ebrahimi Firooz, Khatami Pezhman, Monazah Arina, Alizadeh Ghorban-Ali, Ettehadi Hossein-Ali, Rad Iman, Nojehdehi Shahrzad, Kehtari Mousa, Kouhkan Fatemeh, Barjasteh Hesam, Moradi Sohrab, Ghorbani Mohammad-Hosein, Khodaie Ali, Papizadeh Moslem, Najafi Roghayeh, Naghneh Ehsan, Sadeghi Davood, Karimi Rahjerdi Ahmad
Milad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, Iran.
Stem Cell Technology Research Center (STRC), Building No. 9, 2nd East Alley, Mohammad-Ali Keshavarz Blvd., Saadat Abad, Tehran 1997775555, Iran.
Vaccines (Basel). 2021 Nov 3;9(11):1271. doi: 10.3390/vaccines9111271.
The recent viral infection disease pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in a global public health crisis. Iran, as one of the countries that reported over five million infected cases by September 2021, has been concerned with the urgent development of effective vaccines against SARS-CoV-2. In this paper, we report the results of a study on potency and safety of an inactivated SARS-CoV-2 vaccine candidate (FAKHRAVAC) in a preclinical study so as to confirm its potential for further clinical evaluation. Here, we developed a pilot-scale production of FAKHRAVAC, a purified inactivated SARS-CoV-2 virus vaccine candidate that induces neutralizing antibodies in Balb/c mice, guinea pigs, rabbits, and non-human primates (Rhesus macaques-RM). After obtaining ethical code of IR.IUMS.REC.1399.566, immunizations of animals were conducted by using either of three different vaccine dilutions; High (H): 10 μg/dose, Medium (M): 5 μg/dose, and Low (L): 1 μg/dose, respectively. In the process of screening for viral seeds, viral strains that resulted in the most severe clinical manifestation in patients have been isolated for vaccine development. The viral seed produced the optimal immunity against SARS-CoV-2 virus, which suggests a possible broader neutralizing ability against SARS-CoV-2 strains. The seroconversion rate at the H-, M-, and L-dose groups of all tested animals reached 100% by 28 days after immunization. These data support the eligibility of FAKHRAVAC vaccine candidate for further evaluation in a clinical trial.
由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的近期病毒性传染病大流行已导致全球公共卫生危机。伊朗是截至2021年9月报告感染病例超过500万的国家之一，一直致力于紧急研发针对SARS-CoV-2的有效疫苗。在本文中，我们报告了一项关于一种灭活SARS-CoV-2候选疫苗（FAKHRAVAC）在临床前研究中的效力和安全性的研究结果，以确认其进一步进行临床评估的潜力。在此，我们开展了FAKHRAVAC的中试规模生产，FAKHRAVAC是一种纯化的灭活SARS-CoV-2病毒候选疫苗，可在Balb/c小鼠、豚鼠、兔子和非人类灵长类动物（恒河猴-RM）中诱导中和抗体。在获得IR.IUMS.REC.1399.566伦理代码后，使用三种不同的疫苗稀释液之一对动物进行免疫接种；高（H）：10μg/剂量，中（M）：5μg/剂量，低（L）：1μg/剂量。在筛选病毒种子的过程中，已分离出导致患者出现最严重临床表现的病毒株用于疫苗研发。该病毒种子产生了针对SARS-CoV-2病毒的最佳免疫力，这表明其对SARS-CoV-2毒株可能具有更广泛的中和能力。所有受试动物的高、中、低剂量组在免疫后28天血清转化率均达到100%。这些数据支持FAKHRAVAC候选疫苗有资格在临床试验中进行进一步评估。
