Alimohammadi Reza, Porgoo Meysam, Eftekhary Mohamad, Kiaie Seyed Hossein, Ansari Dezfouli Ehsan, Dehghani Maryam, Nasrollahi Kaveh, Malekshahabi Talieh, Heidari Maryam, Pouya Sedigheh, Alimohammadi Masoumeh, Sattari Khavas Dorsa, Modaresi Mohammad Sadra, Ghasemi Mohammad Hossein, Ramyar Hamed, Mohammadipour Fatemeh, Hamzelouei Fateme, Mofayezi Ahmadreza, Mottaghi Seyed Saeed, Rahmati Amirhosein, Razzaznian Mohsen, Tirandazi Vista, Tat Mahdi, Borzouee Fatemeh, Sadeghi Hossein, Haji Mohammadi Melika, Rastegar Leila, Safar Sajadi Seyed Milad, Ehsanbakhsh Hossein, Bazmbar Hamed, Baghernejadan Zeinab, Shams Nouraei Maedeh, Pazooki Pouya, Pahlavanneshan Mina, Alishah Khadijeh, Nasiri Fateme, Mokhberian Neda, Mohammadi Seyedeh Shima, Akar Shima, Niknam Hamidreza, Azizi Marzieh, Ajoudanian Mohammad, Moteallehi-Ardakani Mohammad Hossein, Mousavi Shaegh Seyed Ali, Ramezani Reihaneh, Salimi Vahid, Moazzami Reza, Hashemi Seyed Mahmoud, Dehghanizadeh Somaye, Khoddami Vahid
Department of Immunology, ReNAP Therapeutics, Tehran, Iran.
Department of Process Engineering, ReNAP Therapeutics, Tehran, Iran.
NPJ Vaccines. 2022 Sep 2;7(1):105. doi: 10.1038/s41541-022-00528-3.
At the forefront of biopharmaceutical industry, the messenger RNA (mRNA) technology offers a flexible and scalable platform to address the urgent need for world-wide immunization in pandemic situations. This strategic powerful platform has recently been used to immunize millions of people proving both of safety and highest level of clinical efficacy against infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here we provide preclinical report of COReNAPCIN; a vaccine candidate against SARS-CoV-2 infection. COReNAPCIN is a nucleoside modified mRNA-based vaccine formulated in lipid nanoparticles (LNPs) for encoding the full-length prefusion stabilized SARS-CoV-2 spike glycoprotein on the cell surface. Vaccination of C57BL/6 and BALB/c mice and rhesus macaque with COReNAPCIN induced strong humoral responses with high titers of virus-binding and neutralizing antibodies. Upon vaccination, a robust SARS-CoV-2 specific cellular immunity was also observed in both mice and non-human primate models. Additionally, vaccination protected rhesus macaques from symptomatic SARS-CoV-2 infection and pathological damage to the lung upon challenging the animals with high viral loads of up to 2 × 10 live viral particles. Overall, our data provide supporting evidence for COReNAPCIN as a potent vaccine candidate against SARS-CoV-2 infection for clinical studies.
在生物制药行业的前沿，信使核糖核酸（mRNA）技术提供了一个灵活且可扩展的平台，以满足大流行情况下全球免疫的迫切需求。这个具有战略意义的强大平台最近已被用于为数百万人接种疫苗，证明了其针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的安全性和最高水平的临床疗效。在此，我们提供了COReNAPCIN的临床前报告；COReNAPCIN是一种针对SARS-CoV-2感染的候选疫苗。COReNAPCIN是一种基于核苷修饰的mRNA疫苗，包裹在脂质纳米颗粒（LNP）中，用于在细胞表面编码全长预融合稳定的SARS-CoV-2刺突糖蛋白。用COReNAPCIN对C57BL/6和BALB/c小鼠以及恒河猴进行疫苗接种，可诱导产生高滴度的病毒结合和中和抗体，从而引发强烈的体液免疫反应。接种疫苗后，在小鼠和非人灵长类动物模型中均观察到了强大的SARS-CoV-2特异性细胞免疫。此外，疫苗接种可保护恒河猴免受有症状的SARS-CoV-2感染，并且在对动物接种高达2×10个活病毒颗粒的高病毒载量后，可防止肺部出现病理损伤。总体而言，我们的数据为COReNAPCIN作为一种针对SARS-CoV-2感染的有效候选疫苗用于临床研究提供了支持性证据。
