Stability of Chimpanzee Adenovirus Vectored Vaccines (ChAdOx1 and ChAdOx2) in Liquid and Lyophilised Formulations.
Stability of Chimpanzee Adenovirus Vectored Vaccines (ChAdOx1 and ChAdOx2) in Liquid and Lyophilised Formulations.
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DOI：
10.3390/vaccines9111249
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发表时间：
2021-10-28
期刊：
影响因子：
7.8
通讯作者：
Douglas AD
中科院分区：
文献类型：
--
作者：
Berg A;Wright D;Dulal P;Stedman A;Fedosyuk S;Francis MJ;Charleston B;Warimwe GM;Douglas AD
腺病毒载体疫苗已在COVID-19大流行期间进入全球使用，并正在开发用于多种其他人类和兽医应用。该技术的一个吸引力是疫苗适合在2-8 °C下储存数月。广泛使用的COVID-19疫苗ChAdOx 1 nCoV-19（牛津大学/阿斯利康）是基于一种E猿腺病毒。种E猴血清型已用于广泛的其他开发项目，但此类载体的稳定性尚未在同行评审文献中广泛描述。在这里，我们探讨了两种候选疫苗的稳定性的基础上两个物种E血清型：裂谷热疫苗的基础上ChAdOx 1载体（Y25血清型）中使用的ChAdOx 1 nCoV-19，和狂犬病疫苗的基础上ChAdOx 2载体（AdC 68血清型）。我们使用体外和体内效力测量来描述每种载体在液体和冻干制剂中的稳定性。我们的数据支持这些载体的液体制剂在2-8 °C下储存长达1年的适用性，并可能在最后一段分销期间短期非冷藏储存（可能在20 ° C下储存1-3天-可接受的最后一段储存条件的精确定义需要进一步的产品特定数据）。根据经济上可接受的过程中效价损失水平，以及与可接受的储存结束效价维持相容的储存中损失水平，先前报道的冻干制剂可以在20 °C下储存更长时间或在30 °C下储存数天。
Adenovirus vectored vaccines have entered global use during the COVID-19 pandemic, and are in development for multiple other human and veterinary applications. An attraction of the technology is the suitability of the vaccines for storage at 2–8 °C for months. Widely used COVID-19 vaccine ChAdOx1 nCoV-19 (University of Oxford/AstraZeneca) is based on a species E simian adenovirus. Species E simian serotypes have been used in a wide range of other development programs, but the stability of such vectors has not been extensively described in the peer-reviewed literature. Here, we explore the stability of two candidate vaccines based on two species E serotypes: a Rift Valley fever vaccine based upon the ChAdOx1 vector (Y25 serotype) used in ChAdOx1 nCoV-19, and a rabies vaccine based upon a ChAdOx2 vector (AdC68 serotype). We describe each vector’s stability in liquid and lyophilised formulations using in vitro and in vivo potency measurements. Our data support the suitability of liquid formulations of these vectors for storage at 2–8 °C for up to 1 year, and potentially for nonrefrigerated storage for a brief period during last-leg distribution (perhaps 1–3 days at 20 °C—the precise definition of acceptable last-leg storage conditions would require further product-specific data). Depending upon the level of inprocess potency loss that is economically acceptable, and the level of instorage loss that is compatible with maintenance of acceptable end-of-storage potency, a previously reported lyophilised formulation may enable longer term storage at 20 °C or storage for a number of days at 30 °C.
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DOI：
10.1016/s0140-6736(20)32661-1
发表时间：
2021-01-09
期刊：
Lancet (London, England)
影响因子：
--
作者：
Voysey M;Clemens SAC;Madhi SA;Weckx LY;Folegatti PM;Aley PK;Angus B;Baillie VL;Barnabas SL;Bhorat QE;Bibi S;Briner C;Cicconi P;Collins AM;Colin-Jones R;Cutland CL;Darton TC;Dheda K;Duncan CJA;Emary KRW;Ewer KJ;Fairlie L;Faust SN;Feng S;Ferreira DM;Finn A;Goodman AL;Green CM;Green CA;Heath PT;Hill C;Hill H;Hirsch I;Hodgson SHC;Izu A;Jackson S;Jenkin D;Joe CCD;Kerridge S;Koen A;Kwatra G;Lazarus R;Lawrie AM;Lelliott A;Libri V;Lillie PJ;Mallory R;Mendes AVA;Milan EP;Minassian AM;McGregor A;Morrison H;Mujadidi YF;Nana A;O'Reilly PJ;Padayachee SD;Pittella A;Plested E;Pollock KM;Ramasamy MN;Rhead S;Schwarzbold AV;Singh N;Smith A;Song R;Snape MD;Sprinz E;Sutherland RK;Tarrant R;Thomson EC;Török ME;Toshner M;Turner DPJ;Vekemans J;Villafana TL;Watson MEE;Williams CJ;Douglas AD;Hill AVS;Lambe T;Gilbert SC;Pollard AJ;Oxford COVID Vaccine Trial Group
通讯作者：
Oxford COVID Vaccine Trial Group
影响因子：
9.2
作者：
Stedman, Anna;Wright, Daniel;Warimwe, George M.
通讯作者：
Warimwe, George M.
影响因子：
5.5
作者：
Afkhami, Sam;LeClair, Daniel A.;Xing, Zhou
通讯作者：
Xing, Zhou
影响因子：
5.1
作者：
Croyle, MA;Cheng, X;Wilson, JM
通讯作者：
Wilson, JM
影响因子：
5.5
作者：
Fedosyuk, Sofiya;Merritt, Thomas;Douglas, Alexander D.
通讯作者：
Douglas, Alexander D.