saRNA SARS-CoV-2 vaccine

saRNA SARS-CoV-2 疫苗

• 批准号: MC_PC_19076
• 负责人: Robin Shattock
• 金额: $ 219.76万
• 依托单位: Imperial College London
• 依托单位国家: 英国
• 项目类别: Intramural
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MC_PC_19076
• 关键词: saRNA; SARS; CoV; vaccine

We will rapidly progress a synthetic vaccine against the novel Coronavirus into humanstudies within months. We have determined the genetic sequence (code) for the dominantsurface exposed protein of the virus, the key target for protective immune responses. Wehave modified this sequence to express a highly stabilised version of the protein,maximising its potential to evoke protective antibodies. We have used this modifiedsequence to generate a ribonucleic acid (RNA) based vaccine that can be amplified withincells following injection, maximising its expression. Our RNA vaccine delivers the geneticinstructions that tell muscles to make the viral surface protein which alerts the immunesystem to make protective antibodies. The advantage of our fully synthetic manufacturingprocess means that millions of doses can be made within weeks. This project will supportclinical grade manufacturing of our candidate vaccine, preclinical safety testing andhealthy volunteer studies to assess safety and immune potency of our vaccine. Shouldthis first phase be successful we would progress to wider clinical testing, including studiesto determine its protective effects against natural infection before making our vaccinewidely available.

我们将在几个月内迅速将针对新型冠状病毒的合成疫苗投入人体研究。我们已经确定了病毒主要表面暴露蛋白的基因序列（代码），这是保护性免疫反应的关键目标。我们修改了该序列以表达该蛋白质的高度稳定版本，最大限度地发挥其激发保护性抗体的潜力。我们使用这种修改后的序列来生成基于核糖核酸（RNA）的疫苗，该疫苗可以在注射后在细胞内扩增，从而最大化其表达。我们的 RNA 疫苗提供遗传指令，告诉肌肉产生病毒表面蛋白，从而提醒免疫系统产生保护性抗体。我们全合成制造工艺的优势意味着可以在几周内生产数百万剂。该项目将支持我们候选疫苗的临床级生产、临床前安全测试和健康志愿者研究，以评估我们疫苗的安全性和免疫效力。如果第一阶段取得成功，我们将进行更广泛的临床测试，包括在广泛使用我们的疫苗之前确定其对自然感染的保护作用的研究。

项目成果

Enhanced immune responses following heterologous vaccination with self-amplifying RNA and mRNA COVID-19 vaccines.

• DOI: 10.1371/journal.ppat.1010885
• 发表时间: 2022-10
• 期刊: PLOS PATHOGENS
• 影响因子: 6.7
• 作者: Elliott, Tamara;Cheeseman, Hannah M.;Evans, Abbey B.;Day, Suzanne;McFarlane, Leon R.;O'Hara, Jessica;Kalyan, Mohini;Amini, Fahimah;Cole, Tom;Winston, Alan;Fidler, Sarah;Pollock, Katrina M.;Harker, James A.;Shattock, Robin J.
• 通讯作者: Shattock, Robin J.

Robin Shattock: novel vaccine developer.

Robin Shattock：新型疫苗开发商。

• DOI: 10.1016/s0140-6736(21)00510-9
• 发表时间: 2021
• 期刊: Lancet (London, England)
• 作者: Samarasekera U

COVAC1 phase 2a expanded safety and immunogenicity study of a self-amplifying RNA vaccine against SARS-CoV-2.

• DOI: 10.1016/j.eclinm.2022.101823
• 发表时间: 2023-02
• 期刊: EClinicalMedicine
• 影响因子: 15.1
• 作者: Szubert AJ;Pollock KM;Cheeseman HM;Alagaratnam J;Bern H;Bird O;Boffito M;Byrne R;Cole T;Cosgrove CA;Faust SN;Fidler S;Galiza E;Hassanin H;Kalyan M;Libri V;McFarlane LR;Milinkovic A;O'Hara J;Owen DR;Owens D;Pacurar M;Rampling T;Skene S;Winston A;Woolley J;Yim YTN;Dunn DT;McCormack S;Shattock RJ;COVAC 1 Study Team
• 通讯作者: COVAC 1 Study Team

COVAC1 Phase 2a Expanded Safety and Immunogenicity Study of a Self-Amplifying RNA Vaccine Against SARS-CoV-2

COVAC1 2a 期扩展了针对 SARS-CoV-2 的自扩增 RNA 疫苗的安全性和免疫原性研究

• DOI: 10.2139/ssrn.4231236
• 发表时间: 2022
• 期刊: SSRN Electronic Journal
• 作者: Szubert A

Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against COVID-19: COVAC1, a Phase I, Dose-Ranging Trial

针对 COVID-19 的自扩增 RNA 疫苗的安全性和免疫原性：COVAC1，I 期剂量范围试验

• DOI: 10.2139/ssrn.3859294
• 发表时间: 2021
• 期刊: SSRN Electronic Journal
• 作者: Pollock K