Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation.
Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation.
复制标题
DOI：
10.1038/s41598-021-03154-6
复制
发表时间：
2021-12-14
影响因子：
4.6
通讯作者：
Montefiori DC
中科院分区：
文献类型：
--
作者：
Huang Y;Borisov O;Kee JJ;Carpp LN;Wrin T;Cai S;Sarzotti-Kelsoe M;McDanal C;Eaton A;Pajon R;Hural J;Posavad CM;Gill K;Karuna S;Corey L;McElrath MJ;Gilbert PB;Petropoulos CJ;Montefiori DC
疫苗诱导的中和抗体（nAb）是被认为与疫苗有效性相关的关键生物标志物。在美国政府赞助的COVID-19疫苗的3期疗效试验中，nAb通过两种不同的经验证的基于假病毒的SARS-CoV-2中和试验进行测量，每次试验使用两种试验中的一种。在此，我们描述并比较了两种测定中获得的nAb滴度。我们观察到，当对世界卫生组织的抗SARS-CoV-2免疫球蛋白国际标准品、COVID-19恢复期血清和mRNA-1273疫苗接种者血清进行两种测定时，一种测定始终产生比另一种更高的nAb滴度。为了克服这一差异的挑战，在比较/结合数据的两种测定，我们评估了三种校准方法，并表明，从两种测定的读数可以校准到一个共同的规模。这些结果可能有助于基于这些检测的数据做出决策，以评估和许可新的或适应性的COVID-19疫苗。
Vaccine-induced neutralizing antibodies (nAbs) are key biomarkers considered to be associated with vaccine efficacy. In United States government-sponsored phase 3 efficacy trials of COVID-19 vaccines, nAbs are measured by two different validated pseudovirus-based SARS-CoV-2 neutralization assays, with each trial using one of the two assays. Here we describe and compare the nAb titers obtained in the two assays. We observe that one assay consistently yielded higher nAb titers than the other when both assays were performed on the World Health Organization’s anti-SARS-CoV-2 immunoglobulin International Standard, COVID-19 convalescent sera, and mRNA-1273 vaccinee sera. To overcome the challenge this difference in readout poses in comparing/combining data from the two assays, we evaluate three calibration approaches and show that readouts from the two assays can be calibrated to a common scale. These results may aid decision-making based on data from these assays for the evaluation and licensure of new or adapted COVID-19 vaccines.
登录
查看更多内容
影响因子：
2
作者：
Huang, Yunda;Huang, Ying;Moodie, Zoe;Li, Sue;Self, Steve
通讯作者：
Self, Steve
BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
DOI：
10.1056/nejmoa2107659
发表时间：
2021-09-23
期刊：
The New England journal of medicine
影响因子：
--
作者：
Heath PT;Galiza EP;Baxter DN;Boffito M;Browne D;Burns F;Chadwick DR;Clark R;Cosgrove C;Galloway J;Goodman AL;Heer A;Higham A;Iyengar S;Jamal A;Jeanes C;Kalra PA;Kyriakidou C;McAuley DF;Meyrick A;Minassian AM;Minton J;Moore P;Munsoor I;Nicholls H;Osanlou O;Packham J;Pretswell CH;San Francisco Ramos A;Saralaya D;Sheridan RP;Smith R;Soiza RL;Swift PA;Thomson EC;Turner J;Viljoen ME;Albert G;Cho I;Dubovsky F;Glenn G;Rivers J;Robertson A;Smith K;Toback S;2019nCoV-302 Study Group
通讯作者：
2019nCoV-302 Study Group
DOI：
10.1016/s0140-6736(21)00432-3
发表时间：
2021-03-06
期刊：
Lancet (London, England)
影响因子：
--
作者：
Voysey M;Costa Clemens SA;Madhi SA;Weckx LY;Folegatti PM;Aley PK;Angus B;Baillie VL;Barnabas SL;Bhorat QE;Bibi S;Briner C;Cicconi P;Clutterbuck EA;Collins AM;Cutland CL;Darton TC;Dheda K;Dold C;Duncan CJA;Emary KRW;Ewer KJ;Flaxman A;Fairlie L;Faust SN;Feng S;Ferreira DM;Finn A;Galiza E;Goodman AL;Green CM;Green CA;Greenland M;Hill C;Hill HC;Hirsch I;Izu A;Jenkin D;Joe CCD;Kerridge S;Koen A;Kwatra G;Lazarus R;Libri V;Lillie PJ;Marchevsky NG;Marshall RP;Mendes AVA;Milan EP;Minassian AM;McGregor A;Mujadidi YF;Nana A;Padayachee SD;Phillips DJ;Pittella A;Plested E;Pollock KM;Ramasamy MN;Ritchie AJ;Robinson H;Schwarzbold AV;Smith A;Song R;Snape MD;Sprinz E;Sutherland RK;Thomson EC;Török ME;Toshner M;Turner DPJ;Vekemans J;Villafana TL;White T;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：
9.4
作者：
Addetia A;Crawford KHD;Dingens A;Zhu H;Roychoudhury P;Huang ML;Jerome KR;Bloom JD;Greninger AL
通讯作者：
Greninger AL