Low immunogenicity to SARS-CoV-2 vaccination among liver transplant recipients.
Low immunogenicity to SARS-CoV-2 vaccination among liver transplant recipients.
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DOI：
10.1016/j.jhep.2021.04.020
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发表时间：
2021-08
影响因子：
25.7
通讯作者：
Katchman H
中科院分区：
文献类型：
--
作者：
Rabinowich L;Grupper A;Baruch R;Ben-Yehoyada M;Halperin T;Turner D;Katchman E;Levi S;Houri I;Lubezky N;Shibolet O;Katchman H
两种SARS-CoV-2 mRNA疫苗被批准用于预防COVID-19感染，据报道疫苗有效性为95%。肝移植（LT）受者存在较低疫苗免疫原性的风险，未纳入注册试验。我们评估了疫苗在这一特殊人群中的免疫原性和安全性。在特拉维夫Sourasky医学中心接受LT的受试者和健康志愿者在接受第二剂Pfizer-BioNTech BNT 162 b2 SARS-CoV-2疫苗后10-20天检测针对刺突蛋白（S）和核衣壳蛋白（N）的SARS-CoV-2 IgG抗体。从患者和医疗记录中收集有关疫苗副作用和临床数据的信息。入组了80名LT接受者。平均年龄为60岁，30%为女性。25名健康志愿者对照组较年轻（平均年龄52.7岁，p = 0.013），大多数为女性（68%，p = 0.002）。所有参与者的IgG N蛋白血清学均为阴性，表明免疫力不是由先前的COVID-19感染引起的。所有对照的IgG S蛋白血清学均为阳性。LT受者的免疫原性明显较低，血清学阳性率仅为47.5%（p <0.001）。抗体滴度在该组中也显著较低（平均95.41 Au/ml对比对照中的200.5 Au/ml，p <0.001）。LT受者中阴性反应的预测因素是年龄较大、估计肾小球滤过率较低以及使用大剂量类固醇和霉酚酸酯治疗。两组均未报告严重不良事件。LT接受者对Pfizer-BioNTech SARS-CoV-2 mRNA疫苗的免疫应答显著降低。影响血清学抗体应答的因素包括年龄、肾功能和免疫抑制药物。这些发现需要重新评估该人群的疫苗方案。Pfizer-BioNTech BNT 162 b2 SARS-CoV-2疫苗在肝移植受者中引起的免疫力明显较差。不到一半的患者产生了足够水平的抗病毒抗体，在那些阳性的患者中，平均抗体水平比健康对照组低2倍。预测无应答的因素是年龄、肾功能和免疫抑制药物。
Two SARS-CoV-2 mRNA vaccines were approved to prevent COVID-19 infection, with reported vaccine efficacy of 95%. Liver transplant (LT) recipients are at risk of lower vaccine immunogenicity and were not included in the registration trials. We assessed vaccine immunogenicity and safety in this special population. LT recipients followed at the Tel-Aviv Sourasky Medical Center and healthy volunteers were tested for SARS-CoV-2 IgG antibodies directed against the Spike-protein (S) and Nucleocapsid-protein (N) 10–20 days after receiving the second Pfizer-BioNTech BNT162b2 SARS-CoV-2 vaccine dose. Information regarding vaccine side effects and clinical data was collected from patients and medical records. Eighty LT recipients were enrolled. Mean age was 60 years and 30% were female. Twenty-five healthy volunteer controls were younger (mean age 52.7 years, p = 0.013) and mostly female (68%, p = 0.002). All participants were negative for IgG N-protein serology, indicating immunity did not result from prior COVID-19 infection. All controls were positive for IgG S-protein serology. Immunogenicity among LT recipients was significantly lower with positive serology in only 47.5% (p <0.001). Antibody titer was also significantly lower in this group (mean 95.41 AU/ml vs. 200.5 AU/ml in controls, p <0.001). Predictors for negative response among LT recipients were older age, lower estimated glomerular filtration rate, and treatment with high dose steroids and mycophenolate mofetil. No serious adverse events were reported in either group. LT recipients developed substantially lower immunological response to the Pfizer-BioNTech SARS-CoV-2 mRNA-based vaccine. Factors influencing serological antibody responses include age, renal function and immunosuppressive medications. The findings require re-evaluation of vaccine regimens in this population. The Pfizer-BioNTech BNT162b2 SARS-CoV-2 vaccine elicited substantially inferior immunity in liver transplant recipients. Less than half of the patients developed sufficient levels of antibodies against the virus, and in those who were positive, average antibody levels were 2x less compared to healthy controls. Factors predicting non-response were older age, renal function and immunosuppressive medications.
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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
影响因子：
5.5
作者：
Levin, Adeera;Stevens, Paul E.
通讯作者：
Stevens, Paul E.
DOI：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
Baden LR;El Sahly HM;Essink B;Kotloff K;Frey S;Novak R;Diemert D;Spector SA;Rouphael N;Creech CB;McGettigan J;Khetan S;Segall N;Solis J;Brosz A;Fierro C;Schwartz H;Neuzil K;Corey L;Gilbert P;Janes H;Follmann D;Marovich M;Mascola J;Polakowski L;Ledgerwood J;Graham BS;Bennett H;Pajon R;Knightly C;Leav B;Deng W;Zhou H;Han S;Ivarsson M;Miller J;Zaks T;COVE Study Group
通讯作者：
COVE Study Group
影响因子：
8.8
作者：
Baluch, A.;Humar, A.;Kumar, D.
通讯作者：
Kumar, D.
影响因子：
25.7
作者：
Cornberg M;Buti M;Eberhardt CS;Grossi PA;Shouval D
通讯作者：
Shouval D