The Safety and Immunogenicity of the mRNA-BNT162b2 SARS-CoV-2 Vaccine in Hemodialysis Patients.
The Safety and Immunogenicity of the mRNA-BNT162b2 SARS-CoV-2 Vaccine in Hemodialysis Patients.
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DOI：
10.3389/fimmu.2021.704773
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发表时间：
2021
影响因子：
7.3
通讯作者：
Lhotta K
中科院分区：
文献类型：
--
作者：
Zitt E;Davidovic T;Schimpf J;Abbassi-Nik A;Mutschlechner B;Ulmer H;Benda MA;Sprenger-Mähr H;Winder T;Lhotta K
血液透析患者是严重COVID-19的高危人群。在这些患者中SARS-CoV-2疫苗接种相关的安全性和免疫原性数据很少。在这项观察性研究中，SARS-CoV-2血清阴性血液透析患者接种了两剂辉瑞/BioNTech mRNA-BNT 162 b2疫苗（COMIRNATY® 30 µg），并随访90天。在接种第一剂和第二剂疫苗后的第一个接种后周期间，在每次透析时评估局部和全身副作用。免疫原性在疫苗接种后四周通过定量抗SARS-CoV-2刺突蛋白IgG抗体（LIAISON® SARS-CoV-2-TrimericS IgG荧光免疫测定法）来测定，所述抗体以适应于WHO国际标准的每毫升结合活性单位（BAU/mL）表示。纳入了50例患者（32%女性，68%男性），平均（SD）年龄为67.6（14.8）岁。第一次注射后轻度局部反应占38%，第二次注射后轻度、中度和重度局部反应分别占29.2%、2.1%和2.1%。全身反应性事件发生频率较低，腹泻（4%轻度，4%中度）和疲乏（8%轻度）是最常见的事件。第一次注射后，使用33.8结合活性单位/毫升（BAU/mL）的测定特异性截止值，42%的患者产生阳性反应，中位（Q1，Q3）抗SARS-CoV-2加标IgG浓度为20.0（11.7，51.0）BAU/mL。第二次注射后，血清阳性患者的百分比增加到97.9%，抗SARS-CoV-2加标IgG浓度为1075（290.8，1735）BAU/mL。较高的年龄和免疫抑制与较低的骨化三醇治疗和先前的血清转化为B肝炎疫苗接种显着较高的抗体浓度。mRNA-BNT 162 b2 SARS-CoV-2疫苗似乎是安全的，耐受性良好，并在血液透析患者中显示出高免疫原性。
Hemodialysis patients are at high risk for severe COVID-19. SARS-CoV-2 vaccination related safety and immunogenicity data in these patients are rare. In this observational study SARS-CoV-2-seronegative hemodialysis patients were vaccinated with two doses of the Pfizer/BioNTech mRNA-BNT162b2 vaccine (COMIRNATY® 30 µg) and followed for 90 days. Local and systemic side effects were assessed at every dialysis session during the first post-vaccination week after the first and second vaccine dose. Immunogenicity was determined four weeks after vaccination by quantifying anti-SARS-CoV-2 spike protein IgG antibodies (LIAISON® SARS-CoV-2-TrimericS IgG chemiluminescent immunoassay) expressed in binding activity units per milliliter (BAU/mL) adapted to the WHO International standard. Fifty patients (32% women, 68% men) with a mean (SD) age of 67.6 (14.8) years were included. Mild local reactions occurred in 38% after the first injection, and in 29.2% with mild, in 2.1% with moderate and in 2.1% with severe degree after the second injection. Systemic reactive events occurred less often, with diarrhea (4% mild, 4% moderate) and fatigue (8% mild) being the most frequent ones. After the first injection 42% of the patients developed a positive response using the assay specific cut-off value of 33.8 binding activity units per milliliter (BAU/mL) with a median (Q1, Q3) anti-SARS-CoV-2 spike IgG concentration of 20.0 (11.7, 51.0) BAU/mL. After the second injection the percentage of seropositive patients increased to 97.9% with an anti-SARS-CoV-2 spike IgG concentration of 1075 (290.8, 1735) BAU/mL. Higher age and immunosuppression were associated with lower, calcitriol treatment and prior seroconversion to hepatitis B vaccination with significantly higher antibody concentration. The mRNA-BNT162b2 SARS-CoV-2 vaccine appears to be safe and well-tolerated and shows a high immunogenicity in hemodialysis patients.
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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：
6.1
作者：
Forbes, Suzanne;Davari, Maria;McCafferty, Kieran
通讯作者：
McCafferty, Kieran
影响因子：
4.8
作者：
Noh, Ji Yun;Song, Joon Young;Kim, Woo Joo
通讯作者：
Kim, Woo Joo
影响因子：
56.9
作者：
Liu, PT;Stenger, S;Modlin, RL
通讯作者：
Modlin, RL
影响因子：
158.5
作者：
STEVENS, CE;ALTER, HJ;SZMUNESS, W
通讯作者：
SZMUNESS, W