The ongoing COVID-19 pandemic, caused by infection with SARS-CoV-2, is having a dramatic and deleterious impact on health services and the global economy. Grim public health statistics highlight the need for vaccines that can rapidly confer protection after a single dose and be manufactured using components suitable for scale-up and efficient distribution. In response, we have rapidly developed repRNA-CoV2S, a stable and highly immunogenic vaccine candidate comprised of an RNA replicon formulated with a novel Lipid InOrganic Nanoparticle (LION) designed to enhance vaccine stability, delivery and immunogenicity. We show that intramuscular injection of LION/repRNA-CoV2S elicits robust anti-SARS-CoV-2 spike protein IgG antibody isotypes indicative of a Type 1 T helper response as well as potent T cell responses in mice. Importantly, a single-dose administration in nonhuman primates elicited antibody responses that potently neutralized SARS-CoV-2. These data support further development of LION/repRNA-CoV2S as a vaccine candidate for prophylactic protection from SARS-CoV-2 infection.

中文翻译：

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单剂量复制RNA疫苗在非人类灵长类动物中诱导针对SARS-CoV-2的中和抗体。

由SARS-CoV-2感染引起的正在进行的COVID-19大流行，对卫生服务和全球经济产生了巨大而有害的影响。严峻的公共卫生统计数据突出显示了对疫苗的需求，这些疫苗可以在单剂后迅速提供保护，并使用适合扩大规模和有效分配的成分生产。作为响应，我们迅速开发了repRNA-CoV2S，这是一种稳定的，高度免疫原性的候选疫苗，它由RNA复制子组成，该复制子与新型脂质无机纳米颗粒（LION）配制在一起，旨在增强疫苗的稳定性，递送和免疫原性。我们显示，肌肉注射LION / repRNA-CoV2S会引起健壮的抗SARS-CoV-2穗状蛋白IgG抗体同种型，表明在小鼠中具有1型T辅助反应以及强效T细胞反应。重要的，在非人灵长类动物中单剂量给药可引起抗体反应，从而有效地中和SARS-CoV-2。这些数据支持进一步开发LION / repRNA-CoV2S作为候选疫苗来预防SARS-CoV-2感染。