nCoV: Rapid Clinical Development of ChAdOx1 nCoV-19

nCoV：ChAdOx1 nCoV-19 的快速临床开发

• 批准号: MC_PC_19055
• 负责人: Sarah Gilbert
• 金额: $ 277.12万
• 依托单位: University of Oxford
• 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_19055
• 关键词: nCoV; Rapid; Clinical; Development; ChAdOx1

ChAdOx1 is a safe and effective vaccine vector that can be used to produce vaccinesagainst many different diseases. Unlike other rapid vaccine technologies, only a singledose of the vaccine is likely to be needed. DNA, mRNA and recombinant protein vaccinestypically require two or three doses to achieve protective immunity. ChAdOx1 has beenused to make a Middle East Respiratory Syndrome Coronavirus vaccine which isprotective in non-human primates after a single dose, and is safe and highly immunogenicin humans as demonstrated in a phase I clinical trial. The same vaccine design has beenfollowed to produce ChAdOx1 nCoV. We now propose to manufacture this vaccine tocGMP and conduct a clinical trial in healthy volunteers in the UK. We will work closely withthe MHRA to complete all required testing of the vaccine and obtain regulatory approval inas short a time as possible, with the aim of initiaiting the clinical trial in June.We will also work with partners to demonstrate protective efficacy of ChAdOx1 nCoV intwo different animal models. This will provide the necessary information to support furtherclinical trials of this vaccine to demonstrate efficacy in humans.

ChAdOx1是一种安全有效的疫苗载体，可用于生产多种不同疾病的疫苗。与其他快速疫苗技术不同，可能只需要单剂疫苗。DNA、mRNA和重组蛋白疫苗通常需要两到三剂才能获得保护性免疫。ChAdOx1已被用于制造中东呼吸综合征冠状病毒疫苗，该疫苗在单剂接种后对非人类灵长类动物具有保护作用，并在I期临床试验中证明对人类是安全和高免疫原性的。同样的疫苗设计也被用于生产ChAdOx1nCoV。我们现在建议生产这种疫苗tocGMP，并在英国的健康志愿者身上进行临床试验。我们将与MHRA密切合作，在尽可能短的时间内完成所有必要的疫苗测试并获得监管部门的批准，以期在6月份启动临床试验。我们还将与合作伙伴合作，在两个不同的动物模型中证明ChAdOx1 nCoV的保护效果。这将提供必要的信息，以支持该疫苗的进一步临床试验，以证明其在人类身上的有效性。

项目成果

Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 lineages circulating in Brazil.

Chadox1 NCOV-19（AZD1222）疫苗对巴西循环的SARS-COV-2谱系的功效。

• DOI: 10.1038/s41467-021-25982-w
• 发表时间: 2021-10-06
• 期刊: Nature communications
• 影响因子: 16.6
• 作者: Clemens SAC;Folegatti PM;Emary KRW;Weckx LY;Ratcliff J;Bibi S;De Almeida Mendes AV;Milan EP;Pittella A;Schwarzbold AV;Sprinz E;Aley PK;Bonsall D;Fraser C;Fuskova M;Gilbert SC;Jenkin D;Kelly S;Kerridge S;Lambe T;Marchevsky NG;Mujadidi YF;Plested E;Ramasamy MN;Simmonds P;Golubchik T;Voysey M;Pollard AJ;AMPHEUS Project;Oxford COVID Vaccine Trial Team
• 通讯作者: Oxford COVID Vaccine Trial Team

Immunological and pathological outcomes of SARS-CoV-2 challenge after formalin-inactivated vaccine immunisation of ferrets and rhesus macaques

雪貂和恒河猴福尔马林灭活疫苗免疫后 SARS-CoV-2 攻击的免疫学和病理学结果

• DOI: 10.1101/2020.12.21.423746
• 发表时间: 2020
• 作者: Bewley K

Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial.

• DOI: 10.1016/s0140-6736(21)00628-0
• 发表时间: 2021-04-10
• 期刊: Lancet (London, England)
• 作者: Emary KRW;Golubchik T;Aley PK;Ariani CV;Angus B;Bibi S;Blane B;Bonsall D;Cicconi P;Charlton S;Clutterbuck EA;Collins AM;Cox T;Darton TC;Dold C;Douglas AD;Duncan CJA;Ewer KJ;Flaxman AL;Faust SN;Ferreira DM;Feng S;Finn A;Folegatti PM;Fuskova M;Galiza E;Goodman AL;Green CM;Green CA;Greenland M;Hallis B;Heath PT;Hay J;Hill HC;Jenkin D;Kerridge S;Lazarus R;Libri V;Lillie PJ;Ludden C;Marchevsky NG;Minassian AM;McGregor AC;Mujadidi YF;Phillips DJ;Plested E;Pollock KM;Robinson H;Smith A;Song R;Snape MD;Sutherland RK;Thomson EC;Toshner M;Turner DPJ;Vekemans J;Villafana TL;Williams CJ;Hill AVS;Lambe T;Gilbert SC;Voysey M;Ramasamy MN;Pollard AJ;COVID-19 Genomics UK consortium;AMPHEUS Project;Oxford COVID-19 Vaccine Trial Group
• 通讯作者: Oxford COVID-19 Vaccine Trial Group

Immunological and pathological outcomes of SARS-CoV-2 challenge following formalin-inactivated vaccine in ferrets and rhesus macaques.

• DOI: 10.1126/sciadv.abg7996
• 发表时间: 2021-09-10
• 期刊: Science advances
• 影响因子: 13.6
• 作者: Bewley KR;Gooch K;Thomas KM;Longet S;Wiblin N;Hunter L;Chan K;Brown P;Russell RA;Ho C;Slack G;Humphries HE;Alden L;Allen L;Aram M;Baker N;Brunt E;Cobb R;Fotheringham S;Harris D;Kennard C;Leung S;Ryan K;Tolley H;Wand N;White A;Sibley L;Sarfas C;Pearson G;Rayner E;Xue X;Lambe T;Charlton S;Gilbert S;Sattentau QJ;Gleeson F;Hall Y;Funnell S;Sharpe S;Salguero FJ;Gorringe A;Carroll M
• 通讯作者: Carroll M

Correlates of protection against symptomatic and asymptomatic SARS-CoV-2 infection.

• DOI: 10.1038/s41591-021-01540-1
• 发表时间: 2021-11
• 期刊: Nature medicine
• 影响因子: 82.9
• 作者: Feng S;Phillips DJ;White T;Sayal H;Aley PK;Bibi S;Dold C;Fuskova M;Gilbert SC;Hirsch I;Humphries HE;Jepson B;Kelly EJ;Plested E;Shoemaker K;Thomas KM;Vekemans J;Villafana TL;Lambe T;Pollard AJ;Voysey M;Oxford COVID Vaccine Trial Group
• 通讯作者: Oxford COVID Vaccine Trial Group